Sophic Logo gordian knotBreast Cancer Clinical Trials Intelligence

Monthly Update Report for Trials Started in February 2026


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1: Summary data from new trials identified for Breast Cancer.


Overview

Number of Trials: 29

These 29 trials focus on breast cancer and other solid tumors, spanning early-stage to metastatic disease. Interventions include novel antibody-drug conjugates (ADCs), immune checkpoint inhibitors, targeted therapies (CDK4/6 inhibitors, SERDs, PARP inhibitors), lifestyle modifications (exercise, diet, time-restricted eating), and diagnostic imaging agents. Several trials evaluate biomarker-driven therapies, particularly for PIK3CA mutations, HER2 status, and TROP2 expression. Supportive care interventions address symptom management, cognitive function, and shared decision-making. Trials emphasize personalized medicine, early detection, and improving quality of life in cancer survivors.

Common Criteria Across Trials

Common Inclusion

  • Age ≥18 years
  • Histologically confirmed breast cancer diagnosis
  • Measurable or evaluable disease per RECIST v1.1
  • ECOG performance status 0-2
  • Adequate organ function (bone marrow, liver, kidney)
  • Life expectancy ≥6 months or ≥12 weeks
  • Ability to provide informed consent
  • Willingness to comply with study procedures
  • Negative pregnancy test for women of childbearing potential
  • Use of effective contraception during study

Common Exclusion

  • Pregnant or breastfeeding
  • Active brain metastases or leptomeningeal disease
  • Uncontrolled intercurrent illness or infection
  • History of other active malignancy within 3-5 years
  • Serious cardiac disease or arrhythmia
  • Psychiatric illness limiting compliance
  • Prior hypersensitivity to study drugs
  • Recent major surgery (within 4 weeks)
  • Active autoimmune disease requiring systemic therapy
  • Known HIV, hepatitis B, or hepatitis C infection (active)

Outcomes Summary

Primary Outcomes

Secondary Outcomes


2: Extracted Trials with New Information


Trials with Special Criteria

Genomic / Biomarker Trials

Unique or Unusual Criteria

Trials with Emerging Treatments


3: Individual Trial Overviews


NCT07340541

TBCRC Evolutionary Clinical Trial for Novel Biomarker-Driven Therapies (EVOLVE-BDT) Genomic-based

Organization/Sponsor: UNC Lineberger Comprehensive Cancer Center


Example patient: A 52-year-old woman with metastatic hormone receptor-positive, HER2-negative breast cancer, ECOG status 1, with accessible metastatic lesions, enrolled in parent protocol LCCC2521, requiring second-line biomarker-driven therapy.

Phase N/A

Interventions

  • Drug: Antiandrogen
    Summary: Blocks androgen receptors to reduce tumor growth in androgen receptor-positive triple-negative breast cancer; enzalutamide and bicalutamide are common agents showing efficacy in clinical trials (Summary of Web Search).
  • Drug: SOC
    Summary: Targets advanced hormone receptor-positive, HER2-negative breast cancer after CDK4/6 inhibitor and anti-estrogen therapy failure; involves immune modulation mechanism (Summary of Web Search).
  • Drug: SERD* + everolimus or capecitabine
    Summary: Combines selective estrogen receptor degrader with mTOR inhibitor everolimus or chemotherapy capecitabine for hormone receptor-positive breast cancer (Summary of Web Search).
  • Drug: SERD* + everolimus
    Summary: Blocks estrogen receptors and inhibits mTOR signaling to suppress cell growth in metastatic ER-positive breast cancer (Summary of Web Search).
  • Drug: SERD* + abemaciclib
    Summary: Combines selective estrogen receptor degrader with CDK4/6 inhibitor abemaciclib to block cell cycle progression in hormone receptor-positive, HER2-negative breast cancer (Summary of Web Search).

Key Inclusion

  • Age 18 years or older
  • ECOG Performance Status 0-2
  • Written informed consent and HIPAA authorization
  • Willing and able to comply with study procedures
  • Must fulfill LCCC2521 Parent Protocol eligibility
  • Consented to LCCC2521 Parent Protocol

Key Exclusion

  • Inaccessible metastatic lesion to research biopsy
  • Already initiated second line therapy
  • Concurrent disease rendering patient inappropriate for study

NCT07227077

An Adaptive Design for Dosing Physical Activity Among Older Cancer Survivors Who Experience Chronic Pain: a Micro-randomized Trial

Organization/Sponsor: Medical College of Wisconsin


Example patient: A 68-year-old English-speaking woman with treated early-stage breast cancer, no metastases or recurrence, who owns a smartphone and experiences chronic pain limiting her physical activity.

Phase N/A

Interventions

  • Behavioral: Physical Activity Promotion Intervention
    Summary: Behavioral intervention using pedometers and printed materials to increase exercise and daily steps in cancer survivors, targeting behavior change to improve health outcomes (Source: Web Search).

Key Inclusion

  • Age greater than or equal to 65 years
  • History of bladder, breast, cervical, colorectal, endometrial, lung, or prostate cancer diagnosis and treatment
  • Fluent in spoken and written English
  • Access to smartphone
  • Ability to understand and sign written informed consent

Key Exclusion

  • Metastatic disease
  • Cancer recurrence

NCT07287098

preEMBER: A Phase 2, Open-label Study Evaluating Imlunestrant in Premenopausal Women With Estrogen Receptor-Positive, HER2-Negative Breast Cancer Genomic-based

Organization/Sponsor: Eli Lilly and Company


Example patient: A 42-year-old premenopausal woman with Stage II ER-positive, HER2-negative invasive breast carcinoma with Ki-67 of 15%, ECOG status 0, no prior cancer treatment, and adequate organ function.

Phase 2

Interventions

  • Drug: Goserelin
    Summary: Goserelin is a synthetic GnRH agonist that suppresses pituitary gonadotropins, decreasing estrogen production in premenopausal women with hormone receptor-positive breast cancer. Available as subcutaneous implant in 3.6 mg and 10.8 mg formulations. Sources: FDA label, NCI Thesaurus, Web Search.
  • Device: pre-filled syringe
    Summary: A syringe designed to dispense a predetermined drug dose without requiring mixing or transfer between containers. Source: NCI Thesaurus.
  • Drug: Tamoxifen 20 mg
    Summary: Tamoxifen blocks estrogen receptors to inhibit growth of estrogen-dependent breast cancer cells and is used for treatment and prevention in high-risk women. Source: Web Search.
  • Drug Combination: Imlunestrant + Goserelin
    Summary: Combination therapy using Imlunestrant as a selective estrogen receptor degrader (SERD) with Goserelin for hormone suppression, studied for ER-positive, HER2-negative breast cancer. Source: Web Search.
  • Drug: Imlunestrant
    Summary: Investigational oral selective estrogen receptor degrader (SERD) that targets estrogen receptors to inhibit tumor growth, showing promising progression-free survival extension in clinical trials. Source: Web Search.

Key Inclusion

  • ER-positive, HER2-negative invasive breast carcinoma
  • Cohort 1: Stage I-III with Ki-67 at least 10%
  • Cohort 2: Early-stage resected breast cancer without distant metastasis
  • Cohort 2: Received at least 4.5 years adjuvant endocrine therapy or 2 years without ovarian suppression
  • Premenopausal women
  • ECOG performance status 0 or 1
  • Adequate organ function
  • Able to swallow capsules or tablets

Key Exclusion

  • Bilateral invasive metastatic, occult primary, or inflammatory breast cancer
  • Prior bilateral oophorectomy or ovarian ablation
  • Prior therapy for invasive or non-invasive breast cancer (Cohort 1)
  • Prior anti-estrogen therapy including for osteoporosis or prevention (Cohort 1)
  • Prior treatment with SERD (Cohort 2)
  • History of other cancer unless in complete remission for minimum 1 year
  • Major surgery within 28 days prior to randomization
  • Current exogenous reproductive hormone therapy

NCT07179809

Pilot Randomized Trial of a Virtual, Group-based Comprehensive Lifestyle Program for Women With Metastatic Breast Cancer: Exploring Dose of Support to Optimize Adherence Genomic-based

Organization/Sponsor: M.D. Anderson Cancer Center


Example patient: A 52-year-old woman with HR-positive/HER2-negative metastatic breast cancer on first-line therapy, sedentary lifestyle with low fruit and vegetable intake, no diabetes, and smartphone access.

Phase N/A

Interventions

  • Behavioral: Demographics/Lifestyle Survey
    Summary: Survey tool targeting women with breast cancer to assess and improve health through nutrition, physical activity, and stress management, aiming to enhance quality of life and clinical outcomes in breast cancer survivorship (Web Search).

Key Inclusion

  • HR+/HER2 negative metastatic breast cancer
  • First- or second-line treatment
  • Life expectancy at least 12 months
  • Females age 18 years or older
  • Consume less than 3 servings of fruit and vegetables per day
  • Less than 150 minutes moderate/vigorous activity per week
  • Mind-body practice less than 4 times per month
  • Smartphone or computer with internet access

Key Exclusion

  • Another primary cancer diagnosis within past 5 years
  • Major thought disorder such as schizophrenia or dementia
  • Communication barriers like hard of hearing
  • Poorly-controlled or uncontrolled diabetes
  • Extreme mobility issues unable to get in and out of chair unassisted

NCT07189871

A Phase 1/2a Study of the Safety, Tolerability, and Preliminary Clinical Activity of 177LuBetaBart, a 177Lu-Labeled Anti-B7-H3 Monoclonal Antibody, in Patients With Relapsed/Refractory, Locally Advanced Inoperable, or Metastatic Solid Tumors

Organization/Sponsor: Radiopharm Theranostics, Ltd


Example patient: A 62-year-old woman with metastatic triple-negative breast cancer refractory to standard chemotherapy, ECOG status 1, with measurable lung metastases and adequate organ function including eGFR 65 mL/min and platelet count 150×10⁹/L.

Phase 1, Phase 2

Interventions

  • Radiopharmaceutical: 177Lu-BetaBart
    Summary: 177Lu-BetaBart is a radiolabeled monoclonal antibody that targets B7-H3 protein on cancer cells, delivering lutetium-177 radiation directly to tumors for targeted radiotherapy in solid malignancies including breast cancer (Web Search).

Key Inclusion

  • Age ≥18 years
  • Histopathologically confirmed CRPC, CRC, NSCLC, SCLC, HNSCC, ovarian, cervical, endometrial, TNBC, or ESCC
  • Documented disease progression during or after most recent anticancer therapy
  • Refractory to or intolerant of standard of care or no standard therapy available
  • At least 1 measurable target lesion per RECIST v1.1 (except CRPC)
  • ECOG performance status ≤2
  • Life expectancy ≥4 months
  • eGFR ≥50 mL/min, platelets ≥100×10⁹/L, ANC ≥1.5×10⁹/L, hemoglobin ≥9 g/dL

Key Exclusion

  • Prior organ transplant
  • Active malignancy except treated cervical intraepithelial neoplasia or non-melanoma skin cancer
  • Residual toxicity ≥Grade 2 from prior anticancer therapy (except alopecia and peripheral neuropathy)
  • eGFR <50 mL/min, platelets <100×10⁹/L, ANC <1.5×10⁹/L, hemoglobin <9 g/dL
  • ALT or AST >3×ULN (>5×ULN with liver metastases)
  • CRPC patients with prior Lu-177-PSMA radioligand therapy
  • Unstable angina, MI within 6 months, NYHA Class II or greater heart failure, QTcF >480 msec
  • Anticancer therapy within 28 days or 5 half-lives prior to first dose

NCT07368998

A Phase II, Randomized, Open-Label Study Evaluating Two Inavolisib Dose Levels in Combination With Fulvestrant in Participants With PIK3CA-Mutated, HR-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer Genomic-based

Organization/Sponsor: Hoffmann-La Roche


Example patient: A 62-year-old postmenopausal woman with ER-positive/HER2-negative metastatic breast cancer harboring PIK3CA mutation who progressed on palbociclib plus letrozole, has no diabetes or lung disease, and is not a candidate for chemotherapy.

Phase II

Interventions

  • Drug: Fulvestrant
    Summary: Fulvestrant is an estrogen receptor antagonist that blocks and degrades estrogen receptors, inhibiting cancer cell growth in hormone-dependent tumors. It is indicated for hormone receptor-positive, HER2-negative advanced breast cancer in postmenopausal women, administered as intramuscular injection (FDA label, NCI Thesaurus).
  • Drug: Inavolisib
    Summary: Inavolisib is a selective PI3Kα inhibitor targeting PIK3CA-mutated breast cancer to inhibit cell proliferation and induce apoptosis. It is being tested in combination therapies for advanced hormone receptor-positive, HER2-negative breast cancer (Summary of Web Search).

Key Inclusion

  • ER-positive/HER2-negative tumor per ASCO/CAP guidelines
  • Disease progression during or after CDK4/6 inhibitor plus endocrine therapy
  • ≤1 prior systemic therapy line in locally advanced or metastatic setting
  • Measurable or evaluable disease per RECIST v1.1
  • ≥1 study-eligible PIK3CA mutation confirmed
  • Endocrine-based therapy recommended, cytotoxic chemotherapy not indicated
  • Life expectancy >6 months

Key Exclusion

  • Metaplastic breast cancer
  • Prior chemotherapy in recurrent locally advanced/metastatic setting
  • Type 2 diabetes requiring systemic treatment or any Type 1 diabetes history
  • Prior PI3K/Akt/mTOR inhibitors in recurrent locally advanced/metastatic setting
  • Requirement for daily supplemental oxygen
  • Symptomatic active lung disease including pneumonitis

NCT07357298

Phase III Trial of Brain MRI Surveillance in Stage IV Breast Cancer Genomic-based

Organization/Sponsor: H. Lee Moffitt Cancer Center and Research Institute


Example patient: A 52-year-old woman with newly diagnosed stage IV HR+/HER2- breast cancer with bone and liver metastases, ECOG status 1, normal renal function, no neurologic symptoms, and no prior brain metastases.

Phase III

Interventions

  • Procedure: Standard of Care Brain Imaging
    Summary: Standard of care brain imaging uses MRI surveillance to detect brain metastases in asymptomatic stage IV breast cancer patients, relying on high-resolution imaging to identify cancerous spread (Summary of Web Search).
  • Procedure: Surveillance Brain MRI
    Summary: Surveillance Brain MRI involves regular scans every 6 months to detect brain metastases early in breast cancer, potentially altering treatment strategies (Summary of Web Search).

Key Inclusion

  • Histologic diagnosis of breast cancer with ER/PR/HER2 status documentation
  • Radiographic evidence of stage IV extracranial disease
  • Enrolled within 60 days of diagnosis or starting first line therapy
  • HR+/HER2- patients may be enrolled within 60 days of starting 2nd line therapy
  • Age ≥ 18 years
  • Life expectancy ≥ 6 months
  • ECOG performance status ≤ 2

Key Exclusion

  • Prior diagnosis or treatment of brain metastases or leptomeningeal disease
  • History of other non-breast malignancy requiring treatment
  • Neurologic symptoms warranting standard screening brain MRI at enrollment
  • Indications warranting brain MRI for other neurologic conditions
  • Contraindication towards MRI with contrast
  • Chronic kidney disease stage IV or V or CrCl <30 ml/min

NCT04362826

A Randomized, Double-blind, Placebo Controlled, Parallel Study to Investigate Efficacy of a Novel Probiotic on the Bacteriome and Mycobiome of Breast Cancer Patients

Organization/Sponsor: Case Comprehensive Cancer Center


Example patient: A 52-year-old woman with newly diagnosed invasive ductal carcinoma, 1.5 cm tumor, BMI 26, no recent antibiotic use, willing to avoid probiotic foods during the study.

Phase N/A

Interventions

  • Dietary Supplement: Novel probiotic
    Summary: Novel probiotics modulate gut and breast microbiomes to enhance immune response against breast cancer through immune system modulation and metabolic changes (Summary of Web Search).
  • Other: Placebo
    Summary: Inactive compound identical in appearance to the probiotic being tested, used to distinguish between active treatment effects and suggestive effects (NCI Thesaurus).

Key Inclusion

  • Diagnosis of breast cancer (invasive ductal carcinoma or invasive lobular carcinoma)
  • Minimum breast tumor size of 1.0 cm
  • BMI between 18.5 to 29.9 kg/m2
  • Agree to abstain from unpasteurized bacteria-fermented foods one week prior to baseline and throughout study
  • Agree to not change dietary habits (apart from avoiding probiotics) and activity levels during study
  • Childbearing potential must use medically approved birth control and have negative pregnancy test

Key Exclusion

  • Pregnant, breastfeeding, or planning pregnancy during trial
  • Use of antibiotics within 5 weeks of randomization
  • History of chronic inflammation or structural abnormality of digestive tract
  • Use of probiotic and/or prebiotic supplements prior to screening and throughout study
  • Change in anti-psychotic medication within 3 months prior to randomization
  • Alcohol or drug abuse in the past year
  • Known allergy to test material's active or inactive ingredients

NCT07387445

Time Restricted Eating During Chemotherapy for Breast Cancer

Organization/Sponsor: University of Illinois at Chicago


Example patient: A 52-year-old woman with Stage II breast cancer, ECOG 0, BMI 32 kg/m2, no diabetes, not on weight loss programs, starting chemotherapy.

Phase N/A

Interventions

  • Behavioral: Time restricted eating
    Summary: Time restricted eating (TRE) is a dietary intervention that targets biological mechanisms in breast cancer by lowering IGF-1 levels and reducing oxidative stress, potentially improving outcomes and reducing chemotherapy side effects (Source: Web Search).

Key Inclusion

  • Age 25-99 years
  • ECOG performance status 0 or 1
  • Histologically confirmed Stage I-III breast cancer or Stage IV with approval
  • Absolute neutrophil count ≥1,500/μL
  • English or Spanish language
  • Negative pregnancy test for women of childbearing potential

Key Exclusion

  • Type 1 or insulin dependent type 2 diabetes
  • BMI >45 kg/m2 or <18.5 kg/m2
  • Pregnant or nursing women
  • Shift workers
  • History of eating disorders
  • Weight change >4kg within 3 months
  • Currently participating in weight loss programs or using GLP-1 medications
  • Illicit drug use within 3 months or excessive alcohol use

NCT07067138

An Exploratory Study Using a Synthetic Lethality-Focused Algorithm to Identify Therapeutic Options in Advanced Metastatic Breast Cancer (SYNTHESIS-Breast) Genomic-based

Organization/Sponsor: National Institutes of Health Clinical Center (CC)


Example patient: A 52-year-old woman with triple-negative metastatic breast cancer, ECOG 1, who progressed after two lines of chemotherapy with measurable lung and liver metastases and adequate organ function.

Phase N/A

Interventions

  • Diagnostic Test: TruSeq Matched Tumor Normal Whole Exome Sequencing Assay
    Summary: Analyzes DNA from tumor and normal cells to identify genetic mutations targeting cancer-related alterations, aiding personalized treatment strategies for breast cancer (Summary of Web Search).
  • Diagnostic Test: TruSight(R) Oncology 500
    Summary: Genomic profiling assay analyzing over 500 genes for mutations, fusions, and alterations in solid tumors to guide treatment decisions (Summary of Web Search).
  • Procedure: Expression Networks for highLIGHting Tumor vulnerabilities (ENLIGHT)
    Summary: Gene-expression profiling intervention identifying tumor vulnerabilities by leveraging expression differences between cancer and healthy cells to enhance cytotoxic effects (Summary of Web Search).

Key Inclusion

  • Histologically confirmed metastatic breast cancer
  • TNBC (ER <10% or PR <10%) or HR+ endocrine-refractory disease
  • HER2-negative per ASCO-CAP guidelines
  • At least one prior line of systemic therapy for metastatic disease
  • Measurable disease per RECIST v1.1
  • Archival FFPE tumor tissue from biopsy within past 6 months
  • ECOG performance status <2
  • Adequate organ and marrow function

Key Exclusion

  • Active visceral crisis
  • Symptomatic brain metastases requiring local therapy
  • Active leptomeningeal disease
  • Uncontrolled intercurrent illness
  • Symptomatic congestive heart failure or unstable angina
  • Lung disease requiring continuous oxygen
  • Decompensated cirrhosis or dialysis-dependent kidney disease
  • Pregnancy

NCT06828588

Pilot Study of [68Ga]Ga-ABY-025 Imaging in Patients Undergoing Treatment With HER2-targeted Therapy Genomic-based

Organization/Sponsor: Vanderbilt-Ingram Cancer Center


Example patient: A 52-year-old woman with HER2-positive metastatic breast cancer with lung and bone metastases, starting trastuzumab therapy, able to lie flat for imaging.

Phase N/A

Interventions

  • Diagnostic Imaging Agent: [68Ga]Ga-ABY-025
    Summary: A radiopharmaceutical diagnostic imaging agent that targets HER2 receptors to quantify HER2 status in tumors, particularly in breast cancer, and visualize metastases (Summary of Web Search).
  • Diagnostic Loading Dose: ABY-025 Loading Dose
    Summary: A loading dose of ABY-025 used in conjunction with the radiolabeled tracer to optimize HER2 receptor imaging in HER2-positive cancers (Summary of Web Search).

Key Inclusion

  • Age ≥ 18 years
  • Unresectable locally advanced or metastatic cancer eligible for HER2-targeted therapy
  • HER2+ solid cancer or breast cancer (HER2+ or HER2-low) by IHC, FISH, or liquid biopsy
  • Measurable disease outside the liver on CT, FDG-PET, or MRI
  • Life expectancy at least 6 months
  • No more than 6 cycles of HER2 treatment received

Key Exclusion

  • Measurable disease only in the liver
  • Hypersensitivity or allergy to [68Ga]Ga-ABY-025
  • Pregnant or breastfeeding
  • HER2-negative cancers without FDA-approved HER2-directed therapy indication
  • Inability to lie flat for 30 minutes
  • Medical or psychiatric co-morbidities preventing study participation

NCT07331077

Movement and Memory After Breast Cancer: The MAMA Trial

Organization/Sponsor: Mayo Clinic


Example patient: A 58-year-old sedentary Hispanic woman with Stage II breast cancer, 8 months post-surgery and radiation, cleared by her physician for exercise participation.

Phase N/A

Interventions

  • Behavioral: Aerobic Exercise
    Summary: Sustained exercise increasing oxygen demand on cardiovascular system, enhancing cardiorespiratory fitness and potentially improving immune function and survival outcomes in cancer patients (NCI Thesaurus, Web Search).
  • Behavioral: Health Education
    Summary: Educational intervention targeting lifestyle, physical activity, and nutrition behavior change to improve self-esteem and treatment adherence in breast cancer patients (Web Search).
  • Diagnostic: Functional Magnetic Resonance Imaging
    Summary: Brain imaging measuring activity via blood flow changes, used to assess chemotherapy-related brain changes and cognitive function in breast cancer patients (Web Search).
  • Assessment: Neurocognitive Assessment
    Summary: Evaluation of cognitive function through testing, targeting brain function to measure and reduce cognitive impairment following cancer treatment (Web Search).
  • Assessment: Physical Performance Testing
    Summary: Tests assessing exercise capacity and physical function including walking speed and timed activities to evaluate fitness and guide treatment management (NCI Thesaurus, Web Search).
  • Assessment: Gait Assessment Test
    Summary: Evaluation of walking patterns and balance targeting muscle strength and coordination, measuring exercise intervention impact on physical function (Web Search).
  • Assessment: Accelerometry
    Summary: Objective measurement of physical activity levels using wearable devices, showing inverse association with breast cancer risk in postmenopausal women (Web Search).
  • Assessment: Questionnaire Administration
    Summary: Patient self-reported outcome collection assessing quality of life, psychological and physical impacts of treatment in breast cancer patients (NCI Thesaurus, Web Search).
  • Assessment: Interview
    Summary: Qualitative method gathering patient-reported outcomes and experiences regarding treatment impact and personal details to inform trial endpoints (NCI Thesaurus, Web Search).
  • Assessment: Electronic Health Record Review
    Summary: Analysis of patient data from electronic records to assess physical activity and quality of life, providing personalized feedback to improve outcomes (NCI Thesaurus, Web Search).

Key Inclusion

  • Age 50 years or older
  • Self-identifies as Hispanic (any race)
  • Stage I-IIIa breast cancer, first-time primary diagnosis
  • Post-surgery, completed primary treatment 3-36 months prior
  • Sedentary, no more than 90 minutes weekly moderate exercise in last 6 months
  • No cognitive impairment (TICS-M score ≥21)
  • Physician clearance for exercise program
  • Willing to be randomized

Key Exclusion

  • Stage 0 or metastatic breast cancer
  • Currently receiving or <3 months since chemotherapy/radiation, or >36 months post-treatment
  • Secondary cancer diagnosis (excluding non-invasive skin cancers)
  • History of stroke, TIA, or neurological disorders
  • Unable to walk without assistance or devices
  • Contraindications to fMRI
  • Enrolled in another physical activity program
  • Pregnancy

NCT07102212

Randomized Clinical Trial of a Telemedicine-mHealth Symptom Cluster Intervention for Advanced Cancer Patients: Increasing Access in Rural Areas

Organization/Sponsor: Ohio State University Comprehensive Cancer Center


Example patient: A 62-year-old English-speaking woman with stage IV breast cancer experiencing moderate insomnia and fatigue, who uses email regularly and has an ECOG performance status of 1.

Phase N/A

Interventions

  • Behavioral: mHealth Intervention
    Summary: Mobile technology-based intervention using telemedicine to address symptom clusters including insomnia, depression, anxiety, and fatigue in advanced cancer patients, offering personalized support and tracking (Web Search).

Key Inclusion

  • Advanced cancer (stage IIIb/c or IV lung, stage IV breast, stage IV prostate, advanced multiple myeloma, stage IIIb/IV melanoma)
  • Age 18 years or older
  • Able to read and write in English
  • Use internet and email
  • Meet clinical cut-offs on at least two symptoms: insomnia (ISI ≥8), depression (PHQ-2 ≥3), anxiety (GAD-2 ≥2), or fatigue (FSI ≥3)

Key Exclusion

  • Night-shift work
  • Untreated bipolar disorder
  • Substance use disorder
  • Cognitive impairment
  • ECOG performance status 3 or greater (in bed 50% or more of day)
  • Less than 6 months predicted survival

NCT07357597

A Phase IV, Open-Label, Single-Arm Study of Prophylaxis for Datopotamab Deruxtecan-related Stomatitis in Eligible Patients With Metastatic or Inoperable Locally Recurrent Breast Cancer or Locally Advanced or Metastatic Epidermal Growth Factor Receptor-Mutated Non-Small Cell Lung Cancer (TROPION-SWISH) Genomic-based

Organization/Sponsor: AstraZeneca


Example patient: A 52-year-old woman with metastatic HR+/HER2- breast cancer who has progressed on endocrine therapy and chemotherapy, ECOG status 1, with adequate bone marrow function and no active oral lesions.

Phase 4

Interventions

  • BLA: Datopotamab Deruxtecan (Dato-DXd)
    Summary: Antibody-drug conjugate targeting Trop-2 combining monoclonal antibody with topoisomerase inhibitor payload for selective tumor cell death in metastatic HR+/HER2- breast cancer, TNBC, and EGFRm NSCLC; FDA approved January 2025 (Web Search).
  • Drug: Dexamethasone mouthwash
    Summary: Corticosteroid mouthwash used prophylactically to prevent chemotherapy-induced stomatitis by reducing oral inflammation; shown effective in reducing mouth sores in clinical trials (Web Search).

Key Inclusion

  • Unresectable or metastatic HR+/HER2- breast cancer with prior endocrine therapy and chemotherapy
  • Unresectable or metastatic TNBC not candidates for PD-1/PD-L1 inhibitor therapy
  • Locally advanced or metastatic EGFRm NSCLC with prior EGFR-directed therapy and platinum-based chemotherapy
  • Age ≥18 years
  • ECOG performance status 0 or 1
  • Adequate bone marrow function (hemoglobin ≥9 g/dL)
  • Negative serum pregnancy test for women of childbearing potential
  • Willing to comply with prophylactic dexamethasone mouthwash

Key Exclusion

  • Prior receipt of Dato-DXd
  • Active and uncontrolled stomatitis or mouth ulcers at baseline
  • Active oral infections where steroid mouthwash is contraindicated
  • Known hypersensitivity to corticosteroids or Dato-DXd ingredients
  • Uncontrolled infection requiring IV antibiotics
  • Clinically significant corneal disease
  • History of severe hypersensitivity to monoclonal antibodies
  • Pregnant, breastfeeding, or planning pregnancy

NCT06502691

[18F]FTT Positron Emission Tomography (PET) in Patients With Metastatic Breast Cancer

Organization/Sponsor: University of Washington


Example patient: A 52-year-old woman with metastatic invasive breast cancer, ECOG status 1, with available archival tumor tissue, starting PARP inhibitor therapy and willing to undergo serial PET imaging and biopsies.

Phase N/A

Interventions

  • Diagnostic Imaging: Positron Emission Tomography
    Summary: PET uses radioactive tracers to visualize metabolic activity in tissues by detecting gamma radiation from positron-electron collisions, helping evaluate treatment response and metastatic spread in breast cancer (NCI Thesaurus, Web Search).
  • Drug: Poly (ADP-Ribose) Polymerase Inhibitor
    Summary: PARP inhibitors block PARP1 enzyme causing DNA damage accumulation in cancer cells, particularly effective in breast cancers with BRCA mutations (Web Search).
  • Drug: Immune Checkpoint Inhibitor
    Summary: ICIs target proteins like PD-1 and CTLA-4 to enhance immune response against cancer cells, used to improve outcomes especially in triple-negative breast cancer (Web Search).
  • Diagnostic Radiopharmaceutical: Fluorine F 18 Fluorthanatrace
    Summary: [18F]FTT is a PET imaging tracer that detects PARP enzyme activity in cancer cells, potentially aiding in breast cancer diagnosis and treatment monitoring (Web Search).
  • Diagnostic Radiopharmaceutical: Fludeoxyglucose F-18
    Summary: FDG F-18 is a positron-emitting radiopharmaceutical that mimics glucose uptake, localizing to areas of increased metabolism to detect cancer with 109.7-minute half-life (FDA label, NCI Thesaurus).
  • Procedure: Electronic Health Record Review
    Summary: Systematic checking and assessment of patient data in electronic health records to improve care and monitor outcomes (NCI Thesaurus).
  • Diagnostic Imaging: Computed Tomography
    Summary: CT uses X-rays and computer processing to construct cross-sectional images for detecting cancer spread and monitoring tumor progression (NCI Thesaurus, Web Search).
  • Procedure: Biopsy of Breast
    Summary: Tissue sample removal from breast or metastatic sites to diagnose cancer and examine cellular characteristics (Web Search).
  • Other: Best Practice
    Summary: Informed treatment recommendation expected to benefit the greatest number of patients within a specific group (NCI Thesaurus).

Key Inclusion

  • Histologically confirmed invasive breast cancer with metastatic disease
  • Candidates for PARP inhibitor as single agent or with ICI per physician discretion
  • Evaluable disease or measurable lesion by RECIST 1.1
  • Age 18 years or older
  • KPS ≥50% or ECOG performance status 0-2
  • Archival FFPE tissue from metastatic site available or willing to undergo biopsy
  • Willing to undergo on-treatment biopsy if on-treatment [18F]FTT PET performed
  • Negative serum pregnancy test within 7 days prior to imaging for women of childbearing potential

Key Exclusion

  • Prior myelodysplastic syndrome or acute myeloid leukemia
  • Pregnant or breastfeeding women
  • Known hypersensitivity to proposed PARP inhibitor
  • Uncontrolled intercurrent illness including active infection or symptomatic heart failure
  • Unstable angina pectoris or cardiac arrhythmia
  • Psychiatric illness or social situations limiting compliance
  • Unable to swallow orally administered medication
  • Gastrointestinal disorders interfering with PARP inhibitor absorption

NCT07285993

Improving Detection and Outcomes in Patients With Metastatic Invasive Lobular Breast Cancer Through Novel F-18 FAPI PET Imaging

Organization/Sponsor: Icahn School of Medicine at Mount Sinai


Example patient: A 52-year-old woman with metastatic invasive lobular breast cancer, ECOG status 1, on stable anticancer therapy with normal liver and kidney function.

Phase N/A

Interventions

  • Diagnostic Test: PET/CT
    Summary: PET/CT uses radioactive tracers to detect cancer cells by showing metabolic activity, evaluates treatment response, and identifies metastases in breast cancer (Summary of Web Search).
  • Radiopharmaceutical: 18F-FDG
    Summary: A radioactive glucose analog with high uptake in tumor cells, not further metabolized after phosphorylation, used in PET scans to detect and monitor breast cancer (NCI Thesaurus, Summary of Web Search).
  • Radiopharmaceutical: 18F-FAPI-74
    Summary: Targets fibroblast activation protein (FAP) for PET imaging to detect metastatic breast cancer with improved accuracy compared to traditional methods, currently in clinical trials (Summary of Web Search).

Key Inclusion

  • Females over 18 years of age
  • Diagnosis of invasive lobular breast cancer with pathologically confirmed metastatic disease
  • ECOG performance status 0-2
  • No planned change in anticancer therapy between FDG and FAPI PET scans

Key Exclusion

  • Patients who are pregnant or lactating
  • Patients who cannot undergo PET/CT scanning
  • Total serum bilirubin or serum creatinine greater than 1.5 times the upper limit of normal

NCT07206121

A Feasibility Study for the SIRA-1000, SIRA® RFA Electrosurgical Device as an Adjunct to Breast Conserving Surgery Genomic-based

Organization/Sponsor: Innoblative Designs, Inc.


Example patient: A 62-year-old woman with a 2.5cm Grade II infiltrating ductal carcinoma that is ER/PR positive and Her2neu negative, located centrally in the left breast with no palpable lymph nodes and good performance status.

Phase N/A

Interventions

  • Device: Radiofrequency ablation Electrosurgical Device
    Summary: Radiofrequency ablation uses high-frequency electrical currents to destroy tumor cells by inducing coagulation necrosis, studied as adjunct to breast conserving surgery for early-stage breast cancer (Summary of Web Search).
  • Procedure: Radiofrequency ablation alone
    Summary: Minimally invasive procedure using high-frequency electrical currents to heat tumors above 60°C, inducing coagulation necrosis to destroy breast cancer cells (Summary of Web Search).

Key Inclusion

  • Biologic female 50 years and older
  • Infiltrating ductal carcinoma ER/PR+ Her2neu-
  • Grade I, II, or III
  • Unicentric unilateral tumor ≤3cm
  • Tumor location ≥2cm from skin
  • Zubrod Performance Status 0-2
  • No palpable lymphadenopathy

Key Exclusion

  • Pregnant or breastfeeding
  • Neoadjuvant chemotherapy
  • Cardiac arrhythmia
  • Active implantable medical devices
  • Current or history of breast implants
  • Multi-centric or bilateral breast cancer
  • Diffuse microcalcifications

NCT07146568

Evaluating the Implementation and Effectiveness of the Pink and Pearl Campaign on Lung Cancer Screening at Christian Hospital

Organization/Sponsor: Washington University School of Medicine


Example patient: A 62-year-old woman with 25 pack-year smoking history presenting for routine screening mammography at Christian Hospital who speaks English and is willing to pursue treatment if cancer is detected.

Phase N/A

Interventions

  • Behavioral: Pink and Pearl Campaign
    Summary: Campaign targeting breast and lung cancer awareness to improve lung cancer screening uptake among eligible women through early detection education (Web Search).

Key Inclusion

  • Undergoing screening mammography at Christian Hospital
  • Ages 50-80 years inclusive
  • 20 pack-year smoking history or quit within past 15 years
  • Can speak and understand English
  • Willing and able to get treatment if lung cancer is found

Key Exclusion

  • Diagnosed with serious health problem limiting life expectancy
  • Previous history of lung cancer
  • Symptoms of lung cancer such as hemoptysis
  • Unexplained weight loss more than 6.8 kg in previous year

NCT07290309

Efficacy of a Group-based Videoconference Intervention to Increase Physical Activity in Cancer Survivors

Organization/Sponsor: Colorado State University


Example patient: A 58-year-old English-speaking breast cancer survivor who completed chemotherapy 6 months ago, currently on aromatase inhibitor therapy, sedentary with controlled blood pressure, and able to walk independently.

Phase N/A

Interventions

  • Behavioral: Asynchronous Group
    Summary: Pre-recorded exercise videos providing aerobic and strength training for cancer patients via remote monitoring and telehealth supervision to improve physical fitness and health outcomes (Summary of Web Search).
  • Behavioral: Virtually Supervised Exercise Sessions
    Summary: Live online group exercise classes designed to reduce fatigue and improve fitness and quality of life in cancer patients through supervised aerobic and strength training (Summary of Web Search).

Key Inclusion

  • Able to speak/read English
  • Diagnosed with any type of cancer within the last 5 years
  • Completed primary or adjuvant treatment (chemotherapy, radiation therapy, surgery)
  • No planned treatment within the next nine months
  • Long-term therapies such as anti-hormone or targeted therapies allowed

Key Exclusion

  • Existing participation in ≥150 minutes per week of moderate intensity aerobic exercise
  • Uncontrolled hypertension
  • Inability to walk without an assistive device
  • Current or planned participation in another structured exercise program

NCT07386444

Effects of Inspiratory Muscle Training Among Breast Cancer Patients Undergoing Active Treatment (IMACT)

Organization/Sponsor: Ohio State University Comprehensive Cancer Center


Example patient: A 52-year-old English-speaking woman with early-stage breast cancer who just started chemotherapy and can exercise independently without assistive devices.

Phase N/A

Interventions

  • Behavioral: Inspiratory muscle training
    Summary: Inspiratory muscle training strengthens breathing muscles to reduce dyspnea and improve respiratory muscle endurance and cycling endurance in breast cancer survivors (Web Search).

Key Inclusion

  • Age ≥ 18 years
  • Within 3 weeks of starting chemotherapy
  • Early-stage breast cancer diagnosis
  • Able to exercise independently without support
  • Ability to read, speak, understand English

Key Exclusion

  • Metastatic breast cancer
  • Unwilling or unable to follow protocol requirements
  • Significant health condition increasing participation risks

NCT07360314

A Phase 1, 2-Part, Multicenter, Open-Label, First-in-Human Study of the Anti-Ly6E Exatecan Antibody-Drug Conjugate M7437 in Participants With Advanced Solid Tumors Genomic-based

Organization/Sponsor: EMD Serono


Example patient: A 58-year-old woman with metastatic triple-negative breast cancer refractory to standard chemotherapy, ECOG status 1, with high Ly6E expression on tumor biopsy and no brain metastases.

Phase 1

Interventions

  • Drug: M7437
    Summary: M7437 is an antibody-drug conjugate targeting Ly6E with exatecan payload, designed for advanced solid tumors with high Ly6E expression including triple-negative breast cancer and other malignancies (Source: Web Search).

Key Inclusion

  • Histologically proven advanced solid tumors with known prevalent and high Ly6E expression
  • Unresectable locally advanced or metastatic solid tumor refractory to standard therapies
  • Triple-negative breast cancer with prior lines of therapy
  • Non-small cell lung cancer, squamous cell carcinoma of head and neck, pancreatic ductal adenocarcinoma, gastric cancer, or epithelial ovarian cancer
  • ECOG Performance Status ≤1
  • Adequate blood, liver, and kidney function

Key Exclusion

  • History of another malignancy within 3 years before enrollment with exceptions
  • Known brain metastases unless treated, stable for 4 weeks, and no neurological symptoms
  • Diarrhea or ileus Grade >1 within 1 week of Cycle 1 Day 1
  • Active chronic inflammatory bowel disease or bowel obstruction
  • History of serious gastrointestinal bleeding within 3 months
  • History of hematopoietic allogenic transplantation

NCT07216495

Pilot Study of an Aerobic Exercise Intervention During Immune Checkpoint Inhibitor Therapy in Early-stage Triple Negative Breast Cancer

Organization/Sponsor: M.D. Anderson Cancer Center


Example patient: A 52-year-old woman with stage 2 triple negative breast cancer, ECOG status 0, scheduled for neoadjuvant carboplatin/paclitaxel with pembrolizumab, physically active and able to walk independently.

Phase N/A

Interventions

  • Behavioral: Exercise
    Summary: Aerobic exercise intervention targeting tumor growth and treatment outcomes through hormone modulation and immune system enhancement, shown to reduce recurrence and improve survival rates in breast cancer (Source: Summary of Web Search).

Key Inclusion

  • Female and male participants 18 years or older
  • Clinical stage 2 or 3 TNBC (ER/PR ≤10%, HER2 negative)
  • Physically able to walk independently without assistive device
  • ECOG Performance Status 0-1
  • Planned neoadjuvant chemoICI therapy (carboplatin/taxane with pembrolizumab)
  • Normal bone marrow function
  • Able to read/complete study forms in English
  • Clearance from medical oncologist

Key Exclusion

  • Uncontrolled cardiac/respiratory disease or symptomatic conditions
  • Stroke or myocardial infarction in past year
  • Corticosteroids >10 mg prednisone equivalent or immunosuppressive medications
  • Infection or vaccination within last 4 weeks
  • HIV-positive on antiretroviral therapy
  • Concurrent participation in therapeutic trial or exercise program
  • Pregnant or medically advised not to exercise
  • Prior or concurrent non-breast malignancy (except curative intent)

NCT07069595

PREDICT-RD: Postoperative Molecular Residual Disease by ctDNA Surveillance in TNBC With Residual Disease Genomic-based

Organization/Sponsor: UNC Lineberger Comprehensive Cancer Center


Example patient: A 52-year-old woman with stage III triple-negative breast cancer who completed neoadjuvant chemotherapy but had RCB III residual disease at surgery, with no distant metastases on imaging.

Phase N/A

Interventions

  • Diagnostic Test: Circulating tumor DNA (ctDNA) testing
    Summary: ctDNA testing detects cancer-derived DNA in blood plasma to monitor treatment response and detect minimal residual disease. It identifies genetic mutations for targeted therapy decisions in breast cancer. Source: NCI Thesaurus, Web Search.
  • Drug: Datopotamab deruxtecan
    Summary: TROP2-directed antibody-drug conjugate delivering topoisomerase I inhibitor DXd to cancer cells. FDA-approved for EGFR-mutated NSCLC and HR+/HER2- breast cancer; shows efficacy in triple-negative breast cancer. Source: FDA label, NCI Thesaurus.

Key Inclusion

  • Age ≥18 years
  • Histologically confirmed TNBC (ER/PR <10%, HER2 0-1+ or FISH negative)
  • Stage II/III TNBC
  • Treated with neoadjuvant systemic therapy
  • Residual disease RCB II/III at surgery
  • No evidence of metastatic disease on staging scans
  • Archival diagnostic or surgical tissue available

Key Exclusion

  • Pregnant or breastfeeding

NCT07123649

Individualizing Approaches to Surveillance Mammography in Older Breast Cancer Survivors - The I-MAMMO Study

Organization/Sponsor: Dana-Farber Cancer Institute


Example patient: An 82-year-old woman with stage II ER-positive breast cancer treated with lumpectomy 18 months ago, currently on letrozole, with recent normal mammogram and receiving follow-up care at Dana-Farber.

Phase N/A

Interventions

  • Behavioral: Shared Decision-Making Toolkit
    Summary: A toolkit that aids breast cancer patients in making informed treatment decisions through shared decision-making principles, helping evaluate treatment options and assess patient-provider communication effectiveness in clinical trials (Source: Web Search).

Key Inclusion

  • Women aged ≥80 years
  • History of stage 0-III breast cancer including DCIS or invasive breast cancer
  • At least one intact breast
  • Mammogram screening within last 24 months
  • ≥12 months since most recent breast surgery to affected breast
  • No active cancer-directed therapy except hormonal therapy and/or CDK 4/6 inhibitor
  • Receiving oncology follow-up care at participating site
  • Most recent mammogram did not recommend additional diagnostic work-up

Key Exclusion

  • History of recurrent or metastatic breast cancer
  • Assigned male sex at birth
  • Breast or imaging findings requiring diagnostic testing at baseline
  • Prior discontinuation of mammography
  • Prior atypical ductal hyperplasia or non-pleomorphic LCIS only
  • Psychiatric illness limiting compliance
  • In hospice care
  • Clinician unwilling to participate

NCT07287995

A Phase 1b/2 Study of ASP2998 as Monotherapy and in Combination With Standard Therapies in Participants With Locally Advanced Unresectable or Metastatic Solid Tumors Genomic-based

Organization/Sponsor: Astellas Pharma Inc


Example patient: A 58-year-old woman with metastatic HER2-negative breast cancer, ECOG status 1, who has progressed after two prior lines of chemotherapy and has measurable lung metastases without CNS involvement.

Phase 1, Phase 2

Interventions

  • Drug: ASP2998
    Summary: ASP2998 is an investigational agent targeting TROP2 and STING pathways to modulate immune responses and enhance anti-tumor activity in solid tumors including breast cancer (Web Search).
  • Drug: Carboplatin
    Summary: Carboplatin is a platinum-based chemotherapy agent that forms DNA cross-links, inducing apoptosis in cancer cells; FDA-approved for ovarian cancer and used in various solid tumors (FDA label, NCI Thesaurus).
  • Drug: Enfortumab Vedotin
    Summary: Enfortumab vedotin is a Nectin-4-directed antibody-drug conjugate delivering MMAE to disrupt microtubules and induce cell death; FDA-approved for locally advanced or metastatic urothelial cancer (FDA label, NCI Thesaurus).
  • Drug: Pembrolizumab
    Summary: Pembrolizumab is a humanized anti-PD-1 monoclonal antibody that blocks PD-1/PD-L1 interaction, enhancing T-cell-mediated immune responses; FDA-approved for multiple solid and hematologic malignancies (FDA label, NCI Thesaurus).

Key Inclusion

  • Locally advanced unresectable or metastatic solid tumors including urothelial carcinoma, NSCLC, gastric/GEJ cancer, or HER2-negative breast cancer
  • ECOG performance status 0 or 1
  • At least one measurable lesion per RECIST v1.1
  • Life expectancy ≥12 weeks
  • Adequate organ function per laboratory values
  • Progressed on or ineligible for standard therapies
  • Known PD-L1 status for NSCLC cohorts without actionable oncogenic alterations
  • No more than 3 prior lines of therapy for expansion cohorts

Key Exclusion

  • Active CNS metastases requiring glucocorticoids
  • History of Grade 4 adverse events or recurrent Grade 3 immune-related adverse events
  • Active autoimmune or inflammatory disorders requiring systemic immunosuppressive therapy within 3 years
  • QTcF ≥470 msec or congenital long QT syndrome
  • Current Grade ≥1 interstitial lung disease or pneumonitis
  • Major surgery within 4 weeks or radiation therapy within 14 days
  • Prior TROP2, STING agonist, or topoisomerase I inhibitor therapy (for most cohorts)
  • Weight <40 kg

NCT07408089

An Open-Label, Multicenter, First-in-Human, Phase 1 Study of BBI-940 in Advanced or Metastatic Breast Cancer: Kinesin Oral Molecular Degrader for Oncology (KOMODO-1) Genomic-based

Organization/Sponsor: Boundless Bio, Inc.


Example patient: A 58-year-old postmenopausal woman with metastatic ER+/HER2- breast cancer without ESR1 mutation, ECOG 1, previously treated with endocrine therapy and CDK4/6 inhibitor, with measurable lung metastases and adequate organ function.

Phase 1

Interventions

  • Drug: BBI-940
    Summary: BBI-940 is a novel oral kinesin protein degrader targeting extrachromosomal DNA segregation to disrupt ecDNA inheritance in cancer cells (Summary of Web Search).
  • Drug: Fulvestrant
    Summary: Fulvestrant is an estrogen receptor antagonist and degrader for hormone receptor-positive, HER2-negative advanced breast cancer in postmenopausal women, administered intramuscularly (FDA label, NCI Thesaurus).

Key Inclusion

  • Locally advanced or metastatic breast cancer (ER+/HER2- or TNBC-LAR with AR ≥10%)
  • Prior standard therapies including endocrine therapy with CDK4/6 inhibition for ER+/HER2-
  • Measurable disease per RECIST v1.1 (except Part 1A)
  • Molecular eligibility: absence of ESR1 mutation (Part 2A) or FGFR1 amplification (Part 2B)
  • Archival or new FFPE tumor tissue available for biomarker analyses
  • ECOG performance status 0 or 1
  • Adequate hematologic, hepatic, renal, and coagulation function
  • Life expectancy at least 12 weeks

Key Exclusion

  • Prior exposure to kinesin inhibitor or degrader
  • Known hypersensitivity to study interventions or excipients
  • Recent anticancer therapy within protocol-defined washout periods
  • Baseline QTcF >470 msec or congenital long QT syndrome
  • Clinically significant pulmonary embolism within 6 weeks
  • Major surgery within 4 weeks or minor surgery within 2 weeks
  • Active infection requiring systemic therapy within 2 weeks
  • Pregnant, breastfeeding, or planning conception during study

NCT07040891

A Pilot Cluster Randomized Controlled Trial of "Just ASK™", an Intervention to Increase Discussions About Breast Cancer Clinical Trials

Organization/Sponsor: University of Pennsylvania


Example patient: A 52-year-old woman newly diagnosed with breast cancer who is being evaluated at the Abramson Cancer Center and has not yet enrolled in any treatment clinical trial.

Phase N/A

Interventions

  • Behavioral: Just ASK training
    Summary: Training program designed to improve oncology team communication skills to increase discussions about breast cancer clinical trial participation with eligible patients.

Key Inclusion

  • Age >18
  • Diagnosed with breast cancer
  • Potentially eligible for at least one breast cancer treatment clinical trial
  • Evaluated at Abramson Cancer Center
  • Able to provide informed consent

Key Exclusion

  • Already consented to participate in a breast cancer clinical trial for their treatment

NCT07320664

Alcohol Counter Marketing as a Breast Cancer Prevention Strategy in Young Women

Organization/Sponsor: Ohio State University Comprehensive Cancer Center


Example patient: A 22-year-old female college student residing in Ohio who drinks alcohol socially several times per month, owns a smartphone, and is not pregnant.

Phase N/A

Interventions

  • Behavioral: Skin Cancer Risk Messages
    Summary: Tailored messages targeting young adults to reduce skin cancer risk by modifying sun protection and UV exposure behaviors (Summary of Web Search).
  • Behavioral: Alcohol and Breast Cancer Risk Messages
    Summary: Co-created counter marketing messages aimed at reducing alcohol consumption in young women to lower breast cancer risk (Summary of Web Search).

Key Inclusion

  • Assigned female at birth
  • Age 18-25 at enrollment
  • Report drinking alcohol at least once in the past 30 days
  • Not pregnant or intending to become pregnant
  • Reside in Ohio, Michigan, Illinois, Wisconsin, or New Jersey
  • Has personal mobile smartphone with texting capabilities

Key Exclusion

  • Assigned male at birth
  • Ages <18 or >25 at enrollment
  • Do not report drinking alcohol at least once in the past 30 days
  • Pregnant or intending to become pregnant
  • Do not reside in Ohio, Michigan, Illinois, Wisconsin, or New Jersey
  • Not willing to complete procedures

NCT06896474

SDM POSSIBLE: A Cluster RCT of a Breast Cancer Treatment Decision Aid for Women 70+ With Low-Risk Stage I Breast Cancers Genomic-based

Organization/Sponsor: Beth Israel Deaconess Medical Center


Example patient: A 74-year-old Spanish-speaking woman with newly diagnosed 1.5 cm ER-positive, HER2-negative, lymph node-negative invasive breast cancer meeting with her surgeon for initial treatment discussion.

Phase N/A

Interventions

  • Behavioral: Shared Decision-Making Training and Decision Aid
    Summary: Collaborative approach where clinicians and breast cancer patients discuss treatment options using decision aids to clarify choices and outcomes, enhancing patient engagement and informed decision-making in breast cancer care (Web Search).

Key Inclusion

  • Biological female aged 70 or older
  • First primary invasive breast cancer
  • Clinically ≤2 cm tumor size
  • Clinically lymph node negative
  • Estrogen receptor positive (ER+) HER2-negative
  • English or Spanish speaking
  • Scheduled with participating surgeon for initial encounter

Key Exclusion

  • Age <70 years
  • Biological males
  • History of invasive breast cancer
  • History of DCIS treated with radiation
  • Paget's disease, inflammatory breast cancer, or Phyllodes tumor
  • In hospice
  • Non-English or non-Spanish speaking
  • Psychiatric illness limiting compliance