Sophic Logo gordian knotBreast Cancer Clinical Trials Intelligence

Monthly Update Report for Trials Started in August 2026


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


Overview

Number of Trials: 20

The 20 trials span breast cancer research including drug therapies (targeted, endocrine, chemotherapy, immunotherapy), device/ablation approaches, supportive care, digital health tools, and lifestyle interventions. Most focus on metastatic or early-stage breast cancer subtypes (HR+/HER2-, HER2+, triple-negative) with genomic or biomarker-driven eligibility. Several trials evaluate novel agents like antibody-drug conjugates, SERDs, and vaccines, while others test behavioral, exercise, or navigation programs to improve quality of life and adherence.

Common Criteria Across Trials

Common Inclusion

  • Age ≥18 years
  • Histologically confirmed breast cancer diagnosis
  • Adequate organ and bone marrow function
  • ECOG performance status 0-2
  • Ability to provide informed consent
  • Negative pregnancy test/contraception use for reproductive-age participants

Common Exclusion

  • Pregnant or breastfeeding individuals
  • Uncontrolled cardiovascular disease
  • Active or uncontrolled infections (HIV, HBV, HCV)
  • Prior therapy with similar investigational agents
  • Significant hepatic or renal impairment
  • Untreated or unstable brain metastases

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


NCT07776613

A Phase II Study Evaluating the Efficacy and Safety of Romosozumab as a Bone-Modifying Agent in Patients With Metastatic Breast Cancer to Bones and Osteoporosis With High Fracture Risk (REMOLD-Breast)

Organization/Sponsor: Memorial Sloan Kettering Cancer Center


Example patient: A 62-year-old woman with ER-positive metastatic breast cancer to bone, on a CDK4/6 inhibitor plus endocrine therapy, with osteoporosis on DXA and no prior bisphosphonate use, normal calcium and vitamin D levels, and no history of MI, stroke, or jaw osteonecrosis.

Phase II

Interventions

  • Biologic (monoclonal antibody): Romosozumab
    Summary: A humanized IgG2 monoclonal antibody that inhibits sclerostin, stimulating bone formation and reducing bone resorption; used here to treat osteoporosis and reduce fracture risk in patients with hormone receptor-positive metastatic breast cancer to bone. Sources: FDA label, NCI Thesaurus, Web Search summary.

Key Inclusion

  • Age ≥18 years
  • Hormone-receptor positive (ER/PR >1%) metastatic breast cancer to bones
  • On any endocrine therapy with/without targeted therapy (CDK4/6, PI3K inhibitors, anti-HER2)
  • Osteoporosis on DXA scan
  • History of fragility fracture of spine or hip
  • Morphometric spine fracture evidence

Key Exclusion

  • Prior bone-modifying agent (IV bisphosphonate or denosumab) for metastatic bone disease
  • Vitamin D <20 ng/mL (unless repleted)
  • MI or stroke within past year
  • Current hyper- or hypocalcemia
  • History of non-healed dental/oral surgery
  • History of osteonecrosis of the jaw

NCT07487844

Image-Guided Pulsed Electric Field (PEF) Ablation of Soft Tissue Lesions in Metastatic Breast Cancer: A Pilot Study

Organization/Sponsor: University of California, San Francisco


Example patient: A 55-year-old woman with metastatic breast cancer and a 3 cm accessible subcutaneous chest wall lesion, ECOG 1, normal blood counts, no pacemaker, and able to pause systemic therapy for the procedure.

Phase N/A

Interventions

  • Procedure: Tumor Ablation
    Summary: Minimally invasive image-guided technique destroying tumor cells via freezing, burning, or electric fields to achieve local control with minimal side effects (Source: Summary of Web Search; NCI Thesaurus).
  • Device: Pulsed Electric Field (PEF) System
    Summary: Investigational device using electromagnetic pulses to disrupt cancer cell homeostasis, inducing regulated cell death and possible immune activation; used here to ablate cutaneous/subcutaneous metastatic breast cancer lesions (Source: Summary of Web Search; NCI Thesaurus).
  • Other: Questionnaires
    Summary: Patient-reported outcome tools assessing symptoms, quality of life, and treatment impact following PEF ablation (Source: Summary of Web Search; NCI Thesaurus).

Key Inclusion

  • Histologically confirmed metastatic breast cancer
  • Measurable cutaneous/subcutaneous lesion 1-5 cm, image-guided accessible
  • Able to withhold systemic therapy 1 week before/2 weeks after PEF
  • Age ≥18 years
  • ECOG performance status ≤2
  • Adequate bone marrow function (ANC ≥1500, platelets ≥100,000)
  • Controlled HIV, HBV, or HCV infection if present
  • Able to withhold anticoagulation/antiplatelet therapy

Key Exclusion

  • Unresolved Grade >2 treatment-related adverse events
  • Pacemaker or other electronic implant
  • Unable to undergo moderate sedation/local anesthesia
  • Pregnant individuals
  • Breastfeeding/chestfeeding individuals
  • Condition impairing ability to comply with study procedures

NCT07685938

Pharmacologic Therapies to Mitigate Radiation-Associated Heart Disease

Organization/Sponsor: UNC Lineberger Comprehensive Cancer Center


Example patient: A 55-year-old non-pregnant woman with breast cancer receiving radiation therapy, not on statins or ACE-inhibitors, with normal blood pressure, consents to blood draws and study participation.

Phase N/A

Interventions

  • Drug: Placebo
    Summary: Inactive comparator with no therapeutic effect, used to assess efficacy of active treatment against radiation-associated heart disease. Source: NCI Thesaurus.
  • Drug: Atorvastatin and Lisinopril
    Summary: Atorvastatin inhibits HMG-CoA reductase to lower cholesterol and may modulate cancer proliferation; lisinopril is an ACE inhibitor controlling blood pressure. Combination studied to mitigate radiation-induced cardiac damage. Source: Summary of Web Search.

Key Inclusion

  • Written informed consent and HIPAA authorization
  • Willing and able to comply with study procedures
  • Consent for serial blood draws and biological specimen use
  • Age ≥ 18 years at consent

Key Exclusion

  • Pregnant or breastfeeding
  • Pre-existing use of a statin or ACE-inhibitor
  • Pre-existing hypotension

NCT07426822

A Phase II Trial to Improve Safety of Capivasertib for HR+/HER2- Metastatic Breast Cancer Genomic-based

Organization/Sponsor: Yale University


Example patient: A 62-year-old postmenopausal woman with HR+/HER2- metastatic breast cancer harboring a PIK3CA mutation, ECOG 1, and normal organ function, eligible for capivasertib plus fulvestrant with no prior AKT/PI3K inhibitor use.

Phase 2

Interventions

  • Antihistamine: Cetirizine
    Summary: Antihistamine used to manage allergy symptoms; included in this trial likely to help manage capivasertib-related skin toxicity. Source: Summary of Web Search.
  • Endocrine therapy: Fulvestrant
    Summary: Estrogen receptor antagonist that degrades ER protein, blocking estrogen signaling in HR+ breast cancer; used with capivasertib for advanced disease. Source: FDA label, NCI Thesaurus.
  • Antidiarrheal: Loperamide
    Summary: Opioid-receptor agonist that reduces GI motility, used to manage diarrhea, a common capivasertib side effect. Source: FDA label, NCI Thesaurus.
  • Kinase inhibitor: Capivasertib
    Summary: AKT inhibitor blocking PI3K/AKT/mTOR signaling, used with fulvestrant for HR+/HER2- metastatic breast cancer with PIK3CA/AKT1/PTEN alterations after endocrine therapy progression. Source: FDA label, NCI Thesaurus.

Key Inclusion

  • Age ≥18 years
  • Metastatic or locally advanced HR+/HER2- breast cancer
  • PIK3CA/AKT1/PTEN alterations confirmed by tumor tissue or ctDNA
  • Eligible for capivasertib and fulvestrant treatment
  • ECOG performance status 0-1
  • Adequate hematologic, hepatic, and renal function
  • Able to swallow oral medication
  • Willing to use effective contraception if of childbearing potential

Key Exclusion

  • Prior treatment with AKT or PI3K inhibitors
  • Uncontrolled diabetes or HbA1c ≥8.0%
  • Brain metastases requiring steroids or leptomeningeal disease
  • Severe or uncontrolled systemic disease/infection
  • History of interstitial lung disease
  • GI disorders precluding drug absorption
  • Recent major surgery or radiotherapy
  • Hypersensitivity to study drugs or excipients

NCT07391774

A Phase III Trial of Rx Therapy Guided by Genomic Risk Assessment For High Anatomic Stage ER-pos/HER2-neg Breast Cancer With RS Less Than or Equal to 25 (RxFINE-Low) Genomic-based

Organization/Sponsor: National Cancer Institute (NCI)


Example patient: A 62-year-old postmenopausal woman with pT2N2 ER-positive (85%), HER2-negative breast cancer, Oncotype DX Recurrence Score 18, normal labs, and no prior endocrine or chemotherapy, eligible for randomization 10 weeks post-surgery.

Phase 3

Interventions

  • Drug: Anastrozole
    Summary: Non-steroidal aromatase inhibitor that blocks estrogen synthesis to treat ER-positive breast cancer in postmenopausal patients. Source: FDA label, NCI Thesaurus.
  • Drug: Exemestane
    Summary: Irreversible steroidal aromatase inhibitor reducing estrogen levels for adjuvant/advanced ER-positive breast cancer treatment. Source: FDA label, NCI Thesaurus.
  • Drug: Letrozole
    Summary: Nonsteroidal aromatase inhibitor reducing estrogen synthesis, used for hormone receptor-positive breast cancer treatment. Source: FDA label, NCI Thesaurus.
  • Drug: Ribociclib Succinate
    Summary: CDK4/6 inhibitor blocking cell cycle progression, used with aromatase inhibitors for HR-positive, HER2-negative breast cancer. Source: FDA label, NCI Thesaurus.
  • Procedure: Biospecimen Collection
    Summary: Collection of tissue/blood samples for genomic and molecular analysis to support research correlatives. Source: NCI Thesaurus.
  • Procedure: Bone Scan
    Summary: Nuclear imaging technique to detect bone metastases via technetium-99m uptake. Source: NCI Thesaurus.
  • Drug: Chemotherapy
    Summary: General cytotoxic treatment targeting rapidly dividing cancer cells; comparator/standard-of-care arm component. Source: NCI Thesaurus.
  • Procedure: Computed Tomography
    Summary: Cross-sectional X-ray imaging used for disease staging and surveillance. Source: NCI Thesaurus.
  • Diagnostic Test: Oncotype DX Breast Cancer Assay
    Summary: 21-gene assay generating a Recurrence Score to guide chemotherapy/endocrine therapy decisions in early ER-positive breast cancer. Source: NCI Thesaurus.
  • Procedure: Positron Emission Tomography
    Summary: Imaging technique using radiotracers to assess metabolic activity and detect metastatic disease. Source: NCI Thesaurus.

Key Inclusion

  • Age ≥18, postmenopausal woman or man
  • ECOG performance status 0-2
  • pT0-T3 with N2/N3 or 3+ positive nodes, no T4
  • ER-positive (>10%) and HER2-negative tumor
  • Final breast cancer surgery <16 weeks prior to registration
  • Oncotype DX Recurrence Score 0-25
  • Adequate organ/marrow function (ANC, platelets, hemoglobin, liver, renal)
  • No prior chemotherapy, endocrine therapy, or CDK4/6 inhibitor for this cancer

Key Exclusion

  • T4 breast cancer
  • Prior invasive ER-positive breast cancer
  • Recurrence Score >25
  • Known contraindication or hypersensitivity to ribociclib
  • Major surgery/radiotherapy within 14 days of randomization
  • QTcF ≥450 msec or abnormal resting heart rate
  • Cardiac disease worse than NYHA class 2
  • Concurrent systemic hormone replacement therapy

NCT07619365

Phase II Trial Evaluating Trastuzumab Deruxtecan and Lovastatin in HER2-low and Ultralow Advanced or Metastatic Breast Cancer (MBC) Genomic-based

Organization/Sponsor: Washington University School of Medicine


Example patient: A 58-year-old woman with HER2-low metastatic breast cancer, ECOG 1, normal organ function, no brain metastases, and no prior T-DXd or statin use.

Phase 2

Interventions

  • Drug: Trastuzumab deruxtecan
    Summary: HER2-directed antibody-drug conjugate delivering a topoisomerase I inhibitor payload to HER2-expressing cells; indicated for HER2-low/positive breast cancer per FDA label.
  • Drug: Lovastatin
    Summary: HMG-CoA reductase inhibitor approved for cholesterol lowering; under investigation for antineoplastic effects including apoptosis induction and radiosensitization (NCI Thesaurus).

Key Inclusion

  • HER2 low (IHC1+/2+) or ultralow breast cancer
  • Advanced/unresectable or metastatic disease
  • No more than 1 prior chemotherapy line
  • Measurable disease per RECIST 1.1
  • Age ≥18
  • ECOG ≤2
  • Adequate organ/bone marrow function
  • LVEF ≥50%

Key Exclusion

  • Prior T-DXd or topoisomerase I ADC use
  • Statin use within 7 days prior
  • Unresolved toxicities from prior therapy
  • Untreated brain metastases
  • History of ILD/pneumonitis requiring steroids
  • Severe pulmonary or cardiovascular disease
  • Pregnant or breastfeeding
  • Uncontrolled active infection

NCT07408856

A Phase I/Ib Study Evaluating Intralesional TLR7 Agonist, CAN1012, in Pre-malignant Ductal Carcinoma in Situ and Lobular Carcinoma in Situ

Organization/Sponsor: Providence Health & Services


Example patient: A 45-year-old woman with a 2 cm biopsy-confirmed DCIS lesion, no invasive disease, normal labs, ECOG 0, and no autoimmune or infectious comorbidities, using non-hormonal contraception.

Phase 1, Phase 1b

Interventions

  • Drug: CAN1012
    Summary: TLR7 agonist administered intratumorally; activates TLR7 pathways to stimulate dendritic cell maturation and cytokine release, driving CTL- and B-cell-mediated antitumor immune responses leading to tumor cell lysis. Source: NCI Thesaurus.

Key Inclusion

  • DCIS or LCIS confirmed by core biopsy
  • Single lesion 1-5 cm without invasive disease
  • US negative for suspicious ipsilateral lymph nodes
  • Age 18 or older
  • ECOG performance status 0-1
  • Adequate hematologic, renal, hepatic labs
  • Negative pregnancy test
  • Agreement to use non-hormonal contraception

Key Exclusion

  • Serious underlying medical/psychiatric condition
  • Need for high-dose corticosteroids
  • Need for hormonal contraception or sensitive CYP substrate medications
  • Active autoimmune disease
  • History of bone marrow transplant or GVHD
  • Active infection requiring systemic therapy
  • Active/uncontrolled Hepatitis B, C, or HIV/AIDS
  • QTc >480 msec or history of bowel perforation risk factors

NCT06811454

A Daily, Digital Mindfulness-Based Intervention for Depressive Symptoms After Serious Medical Illness

Organization/Sponsor: Case Comprehensive Cancer Center


Example patient: A 55-year-old woman with stage II breast cancer who finished chemotherapy 8 months ago, reports moderate depressive symptoms (PHQ-9 score 12), has no suicidal ideation, and owns a smartphone.

Phase N/A

Interventions

  • Behavioral/Control: Enhanced Usual Care (EUC)
    Summary: Standard treatment protocol without added intervention, used as a control arm to benchmark digital mindfulness intervention effects. Source: Summary of Web Search.
  • Behavioral/Digital Intervention: MINDSET
    Summary: Digital mindset-based intervention helping cancer patients adopt adaptive beliefs about cancer and their bodies to reduce depressive symptoms and improve well-being via theory-based cognitive-emotional techniques. Source: Summary of Web Search; NCI Thesaurus.

Key Inclusion

  • Mild to moderately-severe depressive symptoms (PHQ-9 score 5-19)
  • Stage 0-III breast, prostate, or colorectal cancer diagnosis
  • Completed primary cancer treatment within 2 years (excluding hormone therapy)
  • Able to provide informed consent
  • Able to read and speak English
  • Access to a web-enabled device

Key Exclusion

  • Minimal or severe depressive symptoms (PHQ-9 <4 or >20)
  • Suicidal ideation (item 9 PHQ-9 score >1)
  • Comorbid psychological/medical condition requiring priority treatment
  • Current or recent substance abuse/dependence
  • Stage IV cancer diagnosis
  • Active cancer recurrence requiring treatment
  • Active mindfulness practice
  • Prior formal mindfulness program participation

NCT07541079

A Phase IIIb, Single-Arm, Open-Label Study Evaluating Adherence, Tolerability, and Patient Reported Outcomes (PRO) of Giredestrant in Patients With ER+/HER2- Early Breast Cancer Who Are Intolerant to Adjuvant Aromatase Inhibitor Therapy

Organization/Sponsor: Genentech, Inc.


Example patient: A 62-year-old postmenopausal woman with ER+/HER2- Stage II breast cancer, previously treated with surgery and 8 months of letrozole, now experiencing Grade 2 joint pain leading to consideration of switching to giredestrant.

Phase IIIb

Interventions

  • Drug: Giredestrant
    Summary: Oral selective estrogen receptor degrader (SERD) that binds ER, inducing conformational change and degradation, blocking ER-mediated signaling to inhibit growth of ER+ breast cancer cells. Used here as a switch therapy for AI-intolerant early breast cancer patients. Source: NCI Thesaurus.

Key Inclusion

  • ER+/HER2- Stage I-III early breast cancer
  • Postmenopausal female
  • Prior adjuvant AI use ≥6 months, with ≥3 months immediately before consent
  • Grade 2 or 3 AE attributed to AI intolerance
  • First planned switch from AI
  • Completed prior surgery/chemo/radiotherapy as applicable
  • ECOG 0 or 1

Key Exclusion

  • Recent investigational anti-cancer therapy within 6 months
  • Rheumatoid arthritis or other inflammatory connective tissue disease
  • Prior fulvestrant or oral SERD use
  • Active cardiac disease or dysfunction
  • Significant liver disease (Child-Pugh B/C, active hepatitis, cirrhosis)
  • Use of strong CYP3A inhibitors/inducers within 14 days or 5 half-lives
  • Serious medical condition precluding safe participation

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

Organization/Sponsor: M.D. Anderson Cancer Center


Example patient: A 52-year-old woman with HR+/HER2 negative metastatic breast cancer on first-line therapy, sedentary lifestyle, and smartphone access, without other cancers or major cognitive issues.

Phase N/A

Interventions

  • Behavioral/Survey: Demographics/Lifestyle Survey
    Summary: A survey-based lifestyle assessment tool used to evaluate nutrition, physical activity, and stress management behaviors in women with metastatic breast cancer, supporting a virtual group lifestyle intervention aimed at improving quality of life and clinical outcomes. Source: Summary of Web Search.

Key Inclusion

  • HR+/HER2 negative metastatic breast cancer
  • First- or second-line treatment
  • Life expectancy at least 12 months
  • Female, age 18+
  • English literate
  • Smartphone or computer with internet access
  • Low fruit/vegetable intake (<3 servings/day)
  • Low physical activity and mind-body practice frequency

Key Exclusion

  • Another primary cancer diagnosis within 5 years
  • Major thought disorder (e.g., schizophrenia, dementia)
  • Communication barriers
  • Poorly-controlled diabetes
  • Extreme mobility issues

NCT06983691

Evaluating a Patient Navigation Program to Improve Therapy Management for HER2+ Metastatic Breast Cancer Patients Treated With Tucatinib Genomic-based

Organization/Sponsor: Duke University


Example patient: A 52-year-old English-speaking woman with HER2+ metastatic breast cancer currently receiving tucatinib, capecitabine, and trastuzumab, with no cognitive or sensory impairments.

Phase N/A

Interventions

  • Behavioral/Supportive Care: Patient Navigation Program
    Summary: A support service guiding patients through healthcare systems to reduce barriers to treatment access, follow-up, and supportive care; aims to improve therapy management for HER2+ metastatic breast cancer patients on tucatinib-based regimens (Source: NCI Thesaurus; Summary of Web Search).

Key Inclusion

  • Female (sex assigned at birth)
  • Age 18 or older
  • Diagnosed with HER2+ metastatic breast cancer
  • Receiving tucatinib combined with capecitabine and trastuzumab
  • Able to speak and read English

Key Exclusion

  • Visual or hearing impairment
  • Severe cognitive impairment
  • Severe mental illness interfering with participation

NCT07765927

Pilot Feasibility Trial for the Exercise Oncology Clinic in Breast and Gynecologic Oncology Patients

Organization/Sponsor: University of Iowa


Example patient: A 55-year-old woman with stage II breast cancer, medically cleared via PAR-Q+, consents to join a supervised exercise program with no cardiovascular contraindications.

Phase N/A

Interventions

  • Behavioral/Exercise Intervention: Supervised, Personalized Exercise Program
    Summary: A supervised, individualized program combining resistance and aerobic exercise to improve strength, fitness, and quality of life in cancer patients; managed physical activity to reduce fatigue and enhance wellbeing. Source: NCI Thesaurus, Web Search Summary.

Key Inclusion

  • Age 18 years or older
  • Confirmed diagnosis of breast or gynecologic cancer (any stage)
  • Willing to participate in exercise oncology program and research procedures
  • Able to provide informed consent
  • Cleared for exercise via PAR-Q+ and clinical screening

Key Exclusion

  • Absolute contraindications to exercise (e.g., unstable cardiovascular disease)
  • Acute illness precluding safe physical activity
  • Provider determination that patient is not appropriate for exercise
  • Inability to complete required screening procedures including PAR-Q+

NCT07768436

STUDY OF DOSE DENSE CMF (Cyclophosphamide, Methotrexate, Fluorouracil) as an Alternative to AC (Doxorubicin, Cyclophosphamide) in 2 Regimens in EARLY STAGE BREAST CANCER for Patients Greater or Equal to 70 Genomic-based

Organization/Sponsor: Memorial Sloan Kettering Cancer Center


Example patient: A 74-year-old woman with newly diagnosed triple-negative early-stage breast cancer, ECOG performance status 1, adequate organ function, who received one cycle of neoadjuvant carboplatin/paclitaxel without pembrolizumab and is not frail per CARG score.

Phase N/A

Interventions

  • Chemotherapy: Paclitaxel
    Summary: Microtubule inhibitor that disrupts mitotic spindle function, inducing apoptosis in dividing cancer cells; used in breast cancer (adjuvant/metastatic) often combined with carboplatin/pembrolizumab in neoadjuvant triple-negative regimens. Source: FDA label.
  • Chemotherapy regimen: CMF Regimen
    Summary: Combination of alkylating (cyclophosphamide) and antimetabolite (methotrexate, fluorouracil) agents that inhibit DNA synthesis and cell division; used as adjuvant/neoadjuvant therapy for early-stage or triple-negative breast cancer. Source: NCI Thesaurus.

Key Inclusion

  • Histologically confirmed breast adenocarcinoma confirmed at MSK
  • Age ≥70 years
  • ECOG performance status >2 or Karnofsky ≥60%
  • Cohort 1: any histology except HER2+ in adjuvant/neoadjuvant setting
  • Cohort 2: triple negative breast cancer in neoadjuvant setting
  • Cohort 2: received ≥1 dose carboplatin/paclitaxel ± pembrolizumab
  • Adequate hematologic, renal, and hepatic function
  • Written informed consent given

Key Exclusion

  • Stage IV breast cancer
  • CARG frailty score ≥4 (high frail)
  • HER2 3+/amplified breast cancer
  • No prior chemotherapy within 1 year of enrollment
  • Cohort 2: pembrolizumab not permitted during dd CMF treatment

NCT06658912

Planning Grant for Take Off Pounds Sensibly (TOPS) Classes for Breast Cancer Survivors

Organization/Sponsor: Duke University


Example patient: A 52-year-old woman who completed chemotherapy and radiation for breast cancer, has a BMI of 28, no diabetes, and owns a smartphone with internet access.

Phase N/A

Interventions

  • Behavioral: TOPS Classes
    Summary: Community-led weight loss program using peer support and structured strategies to improve health outcomes in breast cancer survivors. Source: Summary of Web Search.

Key Inclusion

  • Women diagnosed with breast cancer
  • BMI ≥ 25 kg/m2
  • Completed primary therapy (surgery, radiation, adjuvant or neo-adjuvant chemotherapy)

Key Exclusion

  • Oncology provider disagrees with participation
  • History of Type II Diabetes Mellitus
  • Currently participating in another weight loss program
  • Currently taking weight loss medication
  • No smartphone or internet access or inability to attend Zoom meetings

NCT07694986

Phase 2 Trial With a Safety Run-in of Combinatorial Therapies With Intrathecal (IT) Dendritic Cell Vaccines (cDC1s) inHER+ (Combined With IT Trastuzumab) and HER2- (Combined With IT Nivolumab) Breast Cancer (BC) Leptomeningeal Disease (LMD) Genomic-based

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


Example patient: A 52-year-old woman with HER2-positive metastatic breast cancer and confirmed leptomeningeal disease, ECOG 1, with an Ommaya reservoir and no active infections or shunts, eligible for IT trastuzumab plus cDC1 vaccine therapy.

Phase 2

Interventions

  • Biologic - Immune checkpoint inhibitor: Nivolumab
    Summary: PD-1 blocking monoclonal antibody that enhances T-cell mediated anti-tumor immunity by blocking PD-1/PD-L1 interaction; used here intrathecally combined with cDC1 vaccine for HER2- BC leptomeningeal disease. Source: FDA label, NCI Thesaurus.
  • Biologic - HER2-targeted monoclonal antibody: Trastuzumab
    Summary: Humanized monoclonal antibody binding HER2 receptor, inhibiting tumor growth and inducing antibody-dependent cytotoxicity; administered intrathecally with cDC1 vaccine for HER2+ BC leptomeningeal disease. Source: FDA label, NCI Thesaurus.
  • Cellular therapy - Dendritic cell vaccine: cDC1 Vaccine
    Summary: Personalized dendritic cell vaccine using patient's own cells to present tumor antigens and stimulate immune response against breast cancer, administered intrathecally via Ommaya reservoir. Source: Summary of Web Search.

Key Inclusion

  • Histologically confirmed breast cancer with leptomeningeal disease (LMD)
  • CSF-positive malignant cells or characteristic radiographic LMD findings
  • ECOG performance status ≤2
  • Prior or planned craniospinal radiotherapy (at least WBRT)
  • Stable coincident brain/spinal metastases allowed
  • Age ≥18 years
  • Life expectancy ≥8 weeks
  • Has Ommaya reservoir or equivalent CSF access device

Key Exclusion

  • Recent LMD-specific treatment within 2 weeks or 5 half-lives
  • Immunotherapy use within past 4 weeks
  • Unable to undergo contrast-enhanced brain MRI
  • Active second malignancy requiring treatment
  • Active infection requiring systemic therapy
  • Presence of ventricular shunt
  • History of intracranial thrombosis
  • Known HIV, active hepatitis B or C infection

NCT07229378

Respiratory Muscle Strength Training to Prevent Dyspnea in the Newly Diagnosed Breast Cancer Patient Prior to Surgery

Organization/Sponsor: University of Florida


Example patient: A 55-year-old English-speaking woman recently diagnosed with breast cancer, scheduled for surgery, with no prior respiratory training, pregnancy, or uncontrolled conditions, able to complete ten sessions.

Phase N/A

Interventions

  • Behavioral: Guided Imagery Exercises
    Summary: Promotes relaxation and reduces stress via visualization, aiding psychological well-being and pain management in breast cancer patients; source: Summary of Web Search, NCI Thesaurus.
  • Behavioral: Respiratory muscle strength training
    Summary: Strengthens diaphragm and intercostal muscles through resistance and endurance breathing exercises to prevent respiratory muscle weakness before surgery; source: Summary of Web Search, NCI Thesaurus.

Key Inclusion

  • Community-dwelling adults over 18
  • Recently diagnosed with breast cancer
  • Scheduled for breast cancer surgery
  • English speaking and able to follow protocol

Key Exclusion

  • Already completed respiratory muscle strength training
  • Pregnancy
  • Recent pneumothorax
  • Ruptured eardrum
  • Uncontrolled hypertension or reflux
  • Cannot complete at least ten exercise sessions

NCT07458113

Sacituzumab Tirumotecan to Treat Patients With Brain Metastases From Triple-negative Breast Cancer Genomic-based

Organization/Sponsor: Yale University


Example patient: A 52-year-old woman with ER/PR-negative, HER2-negative metastatic breast cancer and new progressing brain metastases, ECOG 1, previously treated with an antibody-drug conjugate, with no leptomeningeal disease or uncontrolled comorbidities.

Phase N/A

Interventions

  • Antibody-drug conjugate: Sacituzumab Tirumotecan
    Summary: TROP2-targeting antibody-drug conjugate that delivers a topoisomerase I inhibitor payload to TROP2-expressing tumor cells, causing DNA damage and apoptosis; being studied for intracranial activity in TNBC brain metastases. Sources: NCI Thesaurus, Summary of Web Search.

Key Inclusion

  • Metastatic triple-negative breast cancer (ER<10%, PR<10%, HER2-negative)
  • New or progressing brain metastases
  • Measurable intracranial disease per RANO-BM
  • No immediate need for local CNS therapy
  • ECOG performance status 0-1
  • Prior antibody-drug conjugate therapy required
  • Adequate organ function
  • Controlled HIV/HBV/HCV allowed

Key Exclusion

  • Prior sacituzumab tirumotecan use
  • Documented leptomeningeal disease
  • Uncontrolled seizures or significant CNS/psychiatric disorders
  • Severe cardiovascular or cerebrovascular disease
  • Concomitant anticancer therapy
  • Pregnant or lactating women
  • Active infection requiring systemic therapy
  • Grade >2 pneumonitis/interstitial lung disease

NCT07599618

Evaluation of a Patient-Centered Decision-Making Support Tool for Older Adults With Advanced Breast Cancer and Their Care Partners

Organization/Sponsor: University of Rochester


Example patient: A 68-year-old English-speaking woman with metastatic breast cancer currently undergoing systemic therapy enrolls with her daughter as care partner, both providing informed consent.

Phase N/A

Interventions

  • Behavioral/Digital Health Tool: Decision-making support tool
    Summary: A patient-centered digital decision support tool (Manta Cares platform) that facilitates shared decision-making between patients and care partners regarding treatment choices in metastatic breast cancer; not a drug intervention. Source: Summary of Web Search.

Key Inclusion

  • Diagnosis of metastatic breast cancer
  • Age 65 or older (patient)
  • Currently receiving or considering systemic treatment
  • Able to speak and read English
  • Able to provide informed consent
  • Care partner age 18 or older
  • Verbal permission from patient to enroll care partner

Key Exclusion

  • Early-stage breast cancer
  • Diagnosis of any other cancer besides metastatic breast cancer
  • Care partner enrolled without patient permission

NCT07482384

Supporting Health Including Endocrine Treatment for Long Duration: A Pilot Intervention

Organization/Sponsor: Dana-Farber Cancer Institute


Example patient: A 42-year-old premenopausal woman with stage II HR+ breast cancer, currently on long-term endocrine therapy, fluent in English, and owning a US mobile phone.

Phase N/A

Interventions

  • Digital Health Tool/App: SHIELD portal
    Summary: App-based portal supporting adherence and education for long-term endocrine therapy in HR+ breast cancer patients. Source: Summary of Web Search.

Key Inclusion

  • Female
  • Age 18-49 at diagnosis of stage 0-IIIa HR+ breast cancer
  • Premenopausal
  • Currently in active treatment including long-term endocrine therapy
  • Able to speak, understand, and read English
  • Access to US-based mobile phone number
  • Cognitively able to complete study requirements
  • Willing to receive digital communications from study team

Key Exclusion

  • Age under 18 or over 50 at diagnosis
  • Stage IV or metastatic breast cancer
  • Pregnant patients
  • No US mobile phone number
  • Male sex

NCT07426952

Development and Pilot Testing of a Novel Intervention to Reduce Cardiovascular Disease Risk Among Breast Cancer Survivors Living in Rural, Medically Underserved Communities

Organization/Sponsor: Duke University


Example patient: A 55-year-old woman with stage II breast cancer who completed chemotherapy 2 years ago, has a BMI of 33, reports moderate fatigue and sadness, and has no cognitive or sensory impairments.

Phase N/A

Interventions

  • Behavioral: WeCan-Rural Program
    Summary: A behavioral, home-based program for rural breast cancer survivors combining symptom management, weight management, and psychosocial support to reduce cardiovascular disease risk and improve survivorship outcomes. Source: Summary of Web Search.

Key Inclusion

  • Aged 18 years or older
  • Female (biological sex)
  • Stage I-III breast cancer diagnosis
  • Completed curative-intent treatment (except hormonal therapy) within last 5 years
  • BMI >30
  • Healthy enough for home-based physical activity
  • Able to speak/read English
  • Moderate or greater symptom rating (pain, fatigue, sadness, distress) in last month

Key Exclusion

  • Visual, hearing, or cognitive impairment interfering with participation
  • Severe mental illness interfering with participation