Sophic Logo gordian knotBreast Cancer Clinical Trials Intelligence

Monthly Update Report for Trials Started in May 2026


Powered by Sophic Starlight


Disclaimer and Important Notice:

Sophic does not practice medicine nor provide medical advice. The Sophic Starlight Cancer Clinical Trials Intelligence Report is provided for educational and consulting purposes only. This report is not a substitute for professional medical advice, diagnosis, or treatment. Sophic shall not be held responsible for any interpretation, application, or use of this report beyond these purposes.

The Sophic Starlight Cancer Clinical Trials Intelligence Report is intended solely as an educational resource that provides access to publicly available clinical trial data integrated within Sophic’s proprietary knowledgebase and summarized with AI. Reports are provided entirely free of charge, and patients should never be billed or charged for access to this information. Users agree to reference Sophic in any publication, presentation, or publicity that incorporates or relies upon information from Sophic Starlight Cancer Clinical Trials Intelligence Reports.


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


Overview

Number of Trials: 24

These 24 trials focus on breast cancer treatment, supportive care, and novel therapies. Most target hormone receptor-positive (HR+), HER2-negative advanced or metastatic breast cancer, with several testing next-generation endocrine therapies (SERDs, CDK4/6 inhibitors) and antibody-drug conjugates. Trials also include supportive interventions like exercise programs, digital health tools, patient navigation, and symptom monitoring. Several studies address brain metastases, early-stage disease, and prevention of lymphedema. Experimental agents include camizestrant, elacestrant, imlunestrant, sacituzumab tirumotecan, and CAN1012. Many trials emphasize combination therapies and personalized care delivery models.

Common Criteria Across Trials

Common Inclusion

  • Age 18 years or older
  • Histologically or cytologically confirmed breast cancer
  • ECOG performance status 0-2
  • Adequate organ and bone marrow function
  • Measurable disease per RECIST v1.1
  • Postmenopausal or premenopausal with ovarian suppression
  • Ability to provide informed consent
  • English or Spanish fluency (in some trials)
  • Willingness to use effective contraception

Common Exclusion

  • Metastatic (Stage IV) disease (in early-stage trials)
  • Active uncontrolled infection
  • Pregnant or breastfeeding
  • History of other malignancies within 2-5 years
  • Severe cardiac disease or uncontrolled hypertension
  • Known HIV, HBV, or HCV infection (unless controlled)
  • Active autoimmune disease requiring systemic steroids
  • Prior treatment with the investigational agent
  • Symptomatic brain metastases (unless stable)
  • Cognitive impairment affecting study participation

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


NCT07474090

Supportive Tailored Exercise Program for Survivors of Breast Cancer (STEPS-BC)

Organization/Sponsor: Wake Forest University Health Sciences


Example patient: A 52-year-old woman with newly diagnosed Stage II ER-positive breast cancer, ECOG status 1, scheduled to start adjuvant chemotherapy, who exercises less than 150 minutes weekly and can walk several blocks without difficulty.

Phase N/A

Interventions

  • Procedure: Cardiopulmonary Exercise Testing
    Summary: Evaluates respiratory and cardiovascular responses during exercise to assess fitness and cardiac function under stress, determining if patients can tolerate surgical stress (NCI Thesaurus, Web Search).
  • Other: Electronic Health Record Review
    Summary: Analyzes patient data to improve breast cancer care, targeting physical activity and quality of life through personalized feedback and support (NCI Thesaurus, Web Search).
  • Diagnostic Test: Accelerometry
    Summary: Measures physical activity levels using instruments that quantify movement, showing inverse association with breast cancer risk, particularly in postmenopausal women (NCI Thesaurus, Web Search).
  • Other: Questionnaire Administration
    Summary: Collects patient self-reported outcomes to assess quality of life, psychological and physical impacts of breast cancer treatment (NCI Thesaurus, Web Search).
  • Diagnostic Test: Magnetic Resonance Imaging
    Summary: Noninvasive imaging using radiofrequency waves and magnetic fields to provide detailed breast tissue images for tumor detection, lymph node assessment, and treatment monitoring (NCI Thesaurus, Web Search).
  • Procedure: Biospecimen Collection
    Summary: Gathers tissue and fluid samples for analyzing genetic and molecular features to understand cancer mechanisms and develop targeted therapies (NCI Thesaurus, Web Search).
  • Other: Supportive Care
    Summary: Helps patients cope with cancer and treatment through pain management, psychological support, and practical advice to maximize treatment benefits and improve quality of life (NCI Thesaurus, Web Search).
  • Behavioral: Educational Intervention
    Summary: Educational activity to prevent disease or alter disease course, focusing on increasing screening uptake and improving knowledge about physical, emotional, and lifestyle changes (NCI Thesaurus, Web Search).
  • Behavioral: Exercise Intervention
    Summary: Managed physical activity program to improve health and wellbeing, targeting cancer-related fatigue and modulating tumor microenvironment through mechanisms like p53 activation (NCI Thesaurus, Web Search).

Key Inclusion

  • Stage I-III breast cancer treated with curative intent
  • Scheduled to receive neoadjuvant or adjuvant cytotoxic chemotherapy
  • Age 18 to 85 years
  • ECOG performance status ≤ 2
  • Able to complete stationary bicycle exercise test
  • Able to walk at least 2 blocks without symptoms
  • Must read and understand English
  • Access to teleconferencing device or willing to use Tablet Lending Program

Key Exclusion

  • Symptomatic claustrophobia or MRI-incompatible devices
  • Uncontrolled hypertension (systolic >190 or diastolic >100 mm Hg)
  • Cardiac conditions including unstable angina, symptomatic heart failure, severe valvular disease
  • Acute myocardial infarction within 28 days
  • Acute pulmonary embolus or deep vein thrombosis within 24 weeks
  • Currently engaged in ≥300 minutes moderate to vigorous physical activity per week
  • On simultaneous interventional supportive care clinical trial
  • Undergoing treatment for concurrent second primary cancer

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 diagnosed with stage II hormone receptor-positive breast cancer currently receiving endocrine therapy with ovarian function suppression, who owns a US mobile phone and speaks English.

Phase N/A

Interventions

  • Behavioral: SHIELD portal
    Summary: An app-based tool designed to support women with hormone receptor-positive breast cancer by providing long-term endocrine treatment adherence and education support (Source: Web Search).

Key Inclusion

  • Female
  • Age 18-49 years at diagnosis
  • Stage 0-IIIa HR+ breast cancer
  • Premenopausal
  • In active treatment including long-term endocrine therapy
  • Access to US-based mobile phone number
  • Able to speak, understand and read English

Key Exclusion

  • Under age 18 or over age 50 at initial diagnosis
  • Not being treated with endocrine therapy
  • Stage IV or metastatic breast cancer
  • Pregnant patients
  • No US mobile phone number
  • Males with breast cancer

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 52-year-old postmenopausal woman with biopsy-confirmed DCIS measuring 2.5 cm on mammogram, ECOG status 0, normal laboratory values, no autoimmune disease, and using barrier contraception.

Phase 1

Interventions

  • Drug: CAN1012
    Summary: A Toll-like receptor 7 (TLR7) agonist administered intratumorally that activates antigen-presenting cells and dendritic cells, stimulating cytotoxic T-lymphocyte and B-lymphocyte immune responses leading to tumor cell lysis in pre-malignant breast lesions. Source: NCI Thesaurus.

Key Inclusion

  • DCIS or LCIS found on core biopsy
  • Single lesion ≥1 cm and ≤5 cm by imaging
  • No evidence of invasive disease on biopsy
  • Age 18 years or above
  • ECOG performance status 0-1
  • Adequate hematologic and organ function
  • Negative pregnancy test for childbearing potential
  • Non-hormonal contraception required during treatment

Key Exclusion

  • Serious medical or psychiatric condition interfering with study
  • Corticosteroids ≥10mg prednisone daily equivalent
  • Hormonal contraception use
  • Active autoimmune diseases posing significant risk
  • Active infection requiring systemic therapy
  • Active or uncontrolled Hepatitis B, C, or HIV with AIDS
  • Baseline QTc interval >480 msec
  • History of bowel perforation risk factors still active

NCT07454499

Engaging M-health for Symptom Monitoring and Health Promotion for Women on Endocrine Therapy for Breast Cancer (EmSHAPE)

Organization/Sponsor: Abramson Cancer Center at Penn Medicine


Example patient: A 52-year-old woman with Stage II HR-positive breast cancer who completed lumpectomy three weeks ago, started anastrozole six weeks ago, owns a smartphone, and speaks English fluently.

Phase N/A

Interventions

  • Behavioral: Digital Endocrine therapy Symptom Monitoring and Education Intervention
    Summary: Digital intervention using mobile apps and telemonitoring to help breast cancer patients manage hormone therapy side effects, aiming to improve treatment adherence and symptom control (Source: Web Search Summary).

Key Inclusion

  • Identify as a woman
  • Age 18 or older
  • Stage 0, I, II, or III HR+ breast cancer
  • Started oral endocrine therapy within 16 weeks of registration
  • Completed surgery at least 14 days prior to randomization
  • Own an internet-enabled cell phone
  • Speak and read in English
  • Capable of using electronic pill bottle

Key Exclusion

  • Metastatic (Stage IV) breast cancer
  • Male gender
  • Prior treatment with endocrine therapy for breast cancer
  • Uncorrected hearing or vision impairment
  • Uncorrected speech defects
  • Uncontrolled psychiatric or mental condition
  • Severe physical, neurological or cognitive deficits

NCT07228000

Bundled Cancer Screening and Genetic Services Navigation

Organization/Sponsor: Georgetown University


Example patient: A 52-year-old Hispanic woman with no cancer history, eligible for breast and colorectal cancer screening, seeking navigation services at Georgetown Lombardi Cancer Center.

Phase N/A

Interventions

  • Behavioral: Pretest education + usual care genetics referral
    Summary: Provides genetic counseling and education to women at risk for breast cancer to improve understanding and management of genetic risk without adverse effects (Summary of Web Search).
  • Behavioral: Usual care genetics referral
    Summary: Standard referral practices for genetic counseling targeting patients at high genetic risk for breast cancer to improve access to guideline-recommended services (Summary of Web Search).
  • Behavioral: Multicancer screening navigation
    Summary: Patient support to improve cancer screening and management by overcoming barriers through guidance, advocacy, and education to enhance trial access and outcomes (Summary of Web Search).
  • Behavioral: Breast cancer screening navigation
    Summary: Guides patients through healthcare systems to improve follow-up and adherence to breast cancer screening via personalized support and resource connections (Summary of Web Search).

Key Inclusion

  • Seeking screening navigation services at participating sites
  • Eligible for breast cancer screening and due for colorectal cancer screening per USPSTF guidelines
  • Female sex
  • Aged 45-74
  • Identify as Black/African American race and/or Hispanic/Latin(e)(a) ethnicity
  • Speak English or Spanish with sufficient fluency
  • Willingness to comply with study procedures and availability for study duration
  • Provision of completed electronic informed consent

Key Exclusion

  • Not engaged with navigation programs at participating sites
  • Not eligible for breast or colorectal cancer screening per USPSTF guidelines
  • History of breast and/or colorectal cancer
  • Reporting symptoms related to breast or colorectal cancer
  • Male sex, intersex, or other sex
  • Under age 45 or over age 74
  • Does not identify as Black/African American or Hispanic/Latin(e)(a)
  • Inability to provide electronic informed consent

NCT07502352

Remotely-Delivered Cognitive Behavioral Stress Management Effects on Cancer Accelerated Aging in Older, Distressed Breast Cancer Survivors

Organization/Sponsor: University of Miami


Example patient: A 62-year-old post-menopausal woman with Stage II ER+/PR+/HER2- breast cancer who completed surgery and radiation 6 months ago, currently on adjuvant endocrine therapy with letrozole, experiencing elevated intrusive thoughts and anxiety about recurrence.

Phase N/A

Interventions

  • Behavioral: Standard of Care Survivorship Care Planning
    Summary: A document containing cancer treatment history and guidelines for monitoring health, including future check-ups and potential long-term treatment effects (NCI Thesaurus).
  • Behavioral: Remotely Delivered Cognitive Behavioral Stress Management Intervention (R-CBSM)
    Summary: A digital therapeutic providing cognitive behavioral therapy, relaxation therapy, stress management, and coping strategies to treat anxiety and depression related to cancer diagnoses (NCI Thesaurus).

Key Inclusion

  • 50 years or older
  • Stage I-III HR+ ER/PR+ Her2neu- breast cancer
  • Completed primary treatment 3-12 months prior
  • Post-menopausal (>12 months since last menstrual cycle)
  • Elevated distress (IES-I >14)
  • Undergoing Adjuvant Endocrine Therapy
  • Speaks and reads English or Spanish at 6th grade level

Key Exclusion

  • Metastatic disease, HER2neu+ or Triple Negative breast cancer
  • Prior cancer diagnosis within 2 years (except non-melanoma skin cancer)
  • Active untreated major mental illness (schizophrenia, psychosis, bi-polar, substance abuse, panic disorder, PTSD)
  • Co-morbid medical condition affecting immune system (HIV, autoimmune diseases, hepatitis)
  • Significant cognitive impairment (<32 on TICS)
  • Receipt of immunotherapy as part of treatment
  • Unable or unwilling to provide informed consent

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 52-year-old woman with metastatic breast cancer and a 3 cm subcutaneous chest wall lesion, ECOG status 1, adequate blood counts, able to pause systemic therapy for three weeks around the procedure.

Phase N/A

Interventions

  • Procedure: Tumor Ablation
    Summary: A minimally invasive surgical procedure using image-guided probe to burn solid tumors, applied to soft tissue metastatic breast cancer lesions (NCI Thesaurus).
  • Other: Questionnaires
    Summary: Predetermined set of questions assessing patient-reported outcomes including quality of life and symptom management (NCI Thesaurus, Web Search Summary).
  • Device: Pulsed Electric Field (PEF) System
    Summary: Electromagnetic energy therapy device used to ablate soft tissue lesions in metastatic breast cancer under image guidance (NCI Thesaurus).

Key Inclusion

  • Histologically or cytologically confirmed metastatic breast cancer
  • Soft tissue involvement with measurable lesion 1-5 cm accessible under image guidance
  • Age ≥18 years
  • ECOG performance status ≤2
  • Absolute neutrophil count ≥1,500/mcL and platelets ≥100,000/mcL
  • Able to withhold systemic therapy 1 week before and 2 weeks after PEF ablation
  • Not on or able to withhold anticoagulation per SIR guidelines
  • Adequate contraception for reproductive-age individuals

Key Exclusion

  • Unrecovered adverse events from prior therapy >Grade 2 except alopecia
  • Pacemakers or electronic implant devices
  • Unable or unwilling to undergo moderate sedation and local anesthesia
  • Pregnant individuals
  • Breastfeeding or chestfeeding individuals
  • Condition impairing ability to comply with study procedures

NCT07528638

Feasibility of Using Intraoperative Neuromonitoring (IONM) and Bipolar Electrocautery (BE) During Axillary Lymph Node Dissection (ALND) to Provide Early Identification and Protection of the Intercostalbrachial Nerve (ICBN), Medial Branch Cutaneous Nerve (MBCN), and Their Branches

Organization/Sponsor: University of Cincinnati


Example patient: A 52-year-old woman with newly diagnosed invasive ductal carcinoma requiring axillary lymph node dissection, no prior axillary surgery, no neuropathy, and not taking neuropathic pain medications.

Phase N/A

Interventions

  • Procedure: IONM procedure
    Summary: Intraoperative Neuromonitoring assesses neural structures during surgery using evoked potentials like SSEP and MEP to prevent nerve injury, particularly to intercostalbrachial and medial branch cutaneous nerves during axillary lymph node dissection. Source: Summary of Web Search.

Key Inclusion

  • Ages 18-70 years old
  • Pathologically confirmed diagnosis of breast cancer
  • Undergoing ALND by breast surgeon Sub-Investigator

Key Exclusion

  • Previous axillary surgery other than percutaneous biopsy or SLNB
  • Prior breast radiation with neuropathy
  • Post-chemotherapy neuropathy prior to ALND
  • Pre-existing neurological conditions affecting nerves or neuropathy
  • Taking medications that modify neuropathic pain
  • Prior spinal surgery or cervical spinal pathology
  • Pre-operative breast, arm or chest pain ipsilateral to ALND
  • Significant co-morbidities impacting long-term follow-up

NCT07391956

TIER-PALLIATIVE CARE: A Population-based Care Delivery Model to Match Evolving Patient Needs and Palliative Care Services for Community-based Patients With Heart Failure or Cancer

Organization/Sponsor: Icahn School of Medicine at Mount Sinai


Example patient: A 62-year-old Spanish-speaking woman with triple negative breast cancer residing in Queens, hospitalized once in the past 4 months, with ECOG performance status 1 and three recent outpatient visits at Mount Sinai.

Phase N/A

Interventions

  • Behavioral: Community Health Worker
    Summary: Frontline public health workers who provide education and navigation to increase healthcare access, especially in underserved communities, improving screening rates and health equity (Web Search).
  • Behavioral: Tier-Palliative Care
    Summary: Stepped palliative care model where all patients receive baseline care with systematic monitoring and escalation to specialty-trained clinicians for those needing more intensive treatment (NCI Thesaurus).

Key Inclusion

  • Advanced heart failure with two HF-related hospitalizations within last 12 months
  • Advanced lung or non-colorectal GI cancer or triple negative breast cancer with one hospitalization within last 6 months
  • KPS ≥50% (ECOG 0, 1, or 2)
  • Greater than 2 outpatient MSHS visits in prior 12 months
  • Manhattan or Queens residence
  • Age ≥18 years
  • English or Spanish fluency

Key Exclusion

  • Diagnoses of both cancer and advanced heart failure
  • Lung cancer with driver mutation conferring favorable prognosis
  • More than 1 visit to Outpatient Supportive Oncology/Cardiology
  • Last Supportive Oncology/Cardiology visit less than 3 months ago
  • Previous ventricular assist device or heart transplantation
  • Receiving hospice care or enrolled in another palliative care intervention study
  • Living in a facility
  • Callahan 6-Item Cognitive Screening score ≤3

NCT07596212

BRE-06: Study to Increase Tolerance to Aromatase Inhibitors for Patients With Early-Stage Hormone Receptor Positive Breast Cancer Who Developed Hypoactive Sexual Desire Disorder

Organization/Sponsor: University of Illinois at Chicago


Example patient: A 52-year-old postmenopausal woman with stage II, ER-positive, HER2-negative breast cancer who completed lumpectomy, adjuvant chemotherapy, and radiation therapy six months ago, now on aromatase inhibitor therapy but experiencing hypoactive sexual desire disorder.

Phase N/A

Interventions

  • Drug: GnRH agonist
    Summary: A synthetic analogue of gonadotropin-releasing hormone that binds pituitary GnRH receptors, causing initial stimulation then desensitization, leading to suppression of testosterone in males and estradiol in females, used for hormone-dependent cancers (FDA label, NCI Thesaurus).
  • Drug: Bupropion
    Summary: An aminoketone antidepressant that inhibits reuptake of dopamine and norepinephrine, increasing their central nervous system activity, indicated for major depressive disorder and seasonal affective disorder (FDA label, NCI Thesaurus).
  • Drug: Aromatase Inhibitors
    Summary: Non-steroidal inhibitors of aromatase enzyme that block conversion of androgens to estrogen, reducing estrogen levels in postmenopausal women with hormone receptor-positive breast cancer (FDA label, NCI Thesaurus).

Key Inclusion

  • Females 18 or older
  • Hormone receptor-positive (ER ≥1% and/or PgR ≥1%) early invasive breast cancer, stage I-III
  • Histologically-proven, resected breast cancer
  • Completion of planned surgical resection, adjuvant radiation if needed, and chemotherapy if needed
  • ECOG performance status 0, 1, or 2
  • Ability to swallow oral medication
  • Women of childbearing potential must use effective contraception
  • Willing to return for follow-up and provide informed consent

Key Exclusion

  • Previous bilateral oophorectomy or ovarian irradiation
  • History of psychiatric illnesses on active treatment or suicidal thoughts/behaviors
  • Currently taking anti-depressants, anti-anxiety, or anti-psychotic medications
  • History of seizure disorder, bulimia, or anorexia nervosa
  • History of hypertension regardless of control status
  • Taking CYP2B6 inhibitors/inducers, CYP2D6 substrates, or MAOIs
  • History of angle closure glaucoma
  • Currently receiving radiation therapy or systemic chemotherapy

NCT07426913

Cardiovascular Health Education Via Virtual Reality for Breast Cancer Survivors Receiving Anthracyclines or Trastuzumab - Phase 2

Organization/Sponsor: Virginia Commonwealth University


Example patient: A 52-year-old English-speaking woman with newly diagnosed stage II HER2-positive breast cancer currently receiving trastuzumab and pembrolizumab immunotherapy without any prior breast cancer history.

Phase 2

Interventions

  • Behavioral: Cardiovascular Health Education and Gaming through Virtual Reality
    Summary: Virtual reality-based educational intervention to teach breast cancer survivors about heart health risks from cardiotoxic treatments like anthracyclines and trastuzumab, aiming to improve psychological well-being and quality of life (Web Search).

Key Inclusion

  • 18 years of age or older
  • Able to speak and read in English
  • Actively receiving Trastuzumab or an anthracycline-based treatment
  • Currently receiving immunotherapy (pembrolizumab or atezolizumab)
  • Diagnosed with stages 0-III Breast Cancer

Key Exclusion

  • History of prior Breast Cancer diagnosis (not their first breast cancer diagnosis)

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 52-year-old English-speaking woman recently diagnosed with stage II breast cancer, scheduled for lumpectomy in three weeks, with controlled blood pressure and no history of respiratory muscle training.

Phase N/A

Interventions

  • Behavioral: Guided Imagery Exercises
    Summary: Guided imagery uses visualization techniques to promote relaxation and reduce stress, targeting psychological well-being and pain management by mitigating rumination and worry in breast cancer patients (NCI Thesaurus, Web Search).
  • Behavioral: Respiratory muscle strength training
    Summary: Respiratory muscle strength training strengthens the diaphragm and intercostal muscles through resistance and endurance exercises to improve breathing efficiency and prevent muscle weakness in breast cancer patients undergoing surgery (NCI Thesaurus, Web Search).

Key Inclusion

  • Community-dwelling adults over 18 years
  • Recently diagnosed with breast cancer
  • Scheduled for breast cancer surgery
  • English speaking
  • Can follow the protocol

Key Exclusion

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

NCT07612215

Elacestrant in Advanced Triple Positive Breast Cancer, a Phase II Evaluation (ELATE) Genomic-based

Organization/Sponsor: NYU Langone Health


Example patient: A 52-year-old postmenopausal woman with metastatic triple-positive breast cancer (ER 85%, PR 40%, HER2 3+) who progressed after first-line trastuzumab/pertuzumab/chemotherapy, ECOG 1, LVEF 55%, no CNS metastases, using IUD for contraception.

Phase II

Interventions

  • Drug: Pertuzumab
    Summary: Humanized monoclonal antibody targeting the HER2 extracellular dimerization domain, blocking HER2-mediated signaling pathways to inhibit cancer cell growth and induce apoptosis in HER2-positive breast cancer (FDA label, NCI Thesaurus).
  • Drug: Trastuzumab
    Summary: Humanized monoclonal antibody that selectively binds HER2 receptor, inducing antibody-dependent cell-mediated cytotoxicity against HER2-overexpressing tumor cells in breast and gastric cancers (FDA label, NCI Thesaurus).
  • Drug: Elacestrant
    Summary: Orally available selective estrogen receptor degrader (SERD) that binds ER-alpha causing conformational change and proteosomal degradation, preventing ER-mediated signaling in ER-positive breast cancer including ESR1-mutated disease (FDA label, NCI Thesaurus).

Key Inclusion

  • Female patients aged 18 years or older
  • Triple-positive breast cancer (ER≥10%, PR>1%, HER2 3+ or FISH-amplified)
  • Disease progression on or after at least one line of NCCN recommended therapy
  • ECOG performance status ≤2
  • LVEF ≥50% or ≥institutional LLN
  • Adequate organ function (hemoglobin ≥9.0 g/dL, neutrophils ≥1.5×10³/μL, platelets ≥100×10³/μL)
  • Highly effective non-hormonal contraception required for pre/perimenopausal women

Key Exclusion

  • Prior treatment with a SERD
  • More than two lines of chemotherapy for metastatic disease
  • Untreated and/or active CNS metastases
  • History of other malignancies within past 5 years
  • Gastrointestinal conditions impacting oral drug absorption
  • Known intolerance to elacestrant
  • Uncontrolled active infection
  • Male participants excluded

NCT05326165

Preventing the Progression of Low Volume Swelling to Breast Cancer-related Lymphedema: a Pilot Study

Organization/Sponsor: Massachusetts General Hospital


Example patient: A 52-year-old woman with unilateral invasive breast carcinoma who underwent axillary lymph node dissection 16 weeks ago and now presents with early low-volume arm swelling (RVC 7%) without prior lymphedema treatment or metastatic disease.

Phase N/A

Interventions

  • Device: Compression Sleeve Sensor
    Summary: A compression device that applies consistent pressure to prevent breast cancer-related lymphedema progression while monitoring fluid buildup through integrated sensors to track swelling (Web Search).
  • Device: Juzo Compression Sleeve and Glove
    Summary: A graduated compression garment system designed to reduce swelling and prevent progression of early-stage breast cancer-related lymphedema through consistent pressure application (Web Search).

Key Inclusion

  • Female, age 18 years or older
  • Underwent breast cancer surgery for invasive or in-situ carcinoma
  • Unilateral axillary lymph node dissection (ALND)
  • Low volume swelling (RVC 5-<10%) at least 12 weeks postoperatively
  • Ability to read and comprehend English
  • Willingness to sign written informed consent

Key Exclusion

  • Bilateral breast cancer (contralateral staging SLNB or ALND)
  • Previously diagnosed or treated for breast cancer-related lymphedema
  • Metastases that may cause lymphedema
  • Metastatic disease
  • Implanted cardiac devices (for Sozo measurement)
  • Pregnancy (for Sozo measurement)

NCT07287098

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

Organization/Sponsor: Eli Lilly and Company


Example patient: A 42-year-old premenopausal woman with newly diagnosed Stage II ER-positive, HER2-negative invasive ductal carcinoma with Ki-67 of 25%, ECOG status 0, no prior breast cancer treatment, and adequate organ function.

Phase 2

Interventions

  • Drug: Imlunestrant
    Summary: An oral selective estrogen receptor degrader (SERD) that binds to estrogen receptors, induces conformational change causing ER degradation, and prevents ER-mediated signaling to inhibit growth of ER-expressing breast cancer cells (NCI Thesaurus, FDA label).
  • Drug Combination: Imlunestrant + Goserelin
    Summary: Combination therapy using Imlunestrant as a SERD and Goserelin as a GnRH agonist to lower estrogen levels, targeting ER-positive, HER2-negative breast cancer (Web Search).
  • Drug: Tamoxifen 20 mg
    Summary: A selective estrogen receptor modulator (SERM) that competitively inhibits estradiol binding to estrogen receptors, reducing DNA synthesis and cellular response to estrogen in breast cancer treatment (FDA label, NCI Thesaurus).
  • Device: pre-filled syringe
    Summary: A syringe designed to dispense a predetermined drug dose without requiring mixing or transfer between containers (NCI Thesaurus).
  • Drug: Goserelin
    Summary: A synthetic GnRH agonist that binds pituitary GnRH receptors, suppressing gonadotropin secretion and decreasing estradiol levels in females, used for hormone receptor-positive breast cancer (FDA label, NCI Thesaurus).

Key Inclusion

  • ER-positive, HER2-negative invasive breast cancer
  • Stage I to III with Ki-67 at least 10% (Cohort 1)
  • Early-stage resected breast cancer (Cohort 2)
  • Premenopausal women
  • ECOG performance status 0 or 1
  • Adequate organ function
  • At least 4.5 years adjuvant endocrine therapy or 2 years without ovarian suppression (Cohort 2)
  • 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 (Cohort 1)
  • Prior SERD therapy (Cohort 2)
  • History of other cancer unless in remission for 1 year
  • Major surgery within 28 days
  • Current exogenous reproductive hormone therapy

NCT07488676

A Phase 1b/2 Open-label Study to Assess the Safety and Efficacy of ASP546C in Participants With CLDN18.2-expressing Locally Advanced Unresectable or Metastatic Gastroesophageal Adenocarcinoma, Pancreatic Adenocarcinoma or Other Solid Tumor Types Genomic-based

Organization/Sponsor: Astellas Pharma Inc


Example patient: A 58-year-old woman with ER+/PR+/HER2- metastatic invasive breast cancer expressing CLDN18.2, ECOG status 1, who progressed after one line of chemotherapy for metastatic disease and has no brain metastases or active infections.

Phase 1, Phase 2

Interventions

  • Drug: ASP546C
    Summary: ASP546C is an antibody-drug conjugate targeting CLDN18.2 that delivers cytotoxic agents to CLDN18.2-positive cancer cells, currently in Phase 3 trials for solid tumors including breast cancer (source: Web Search).

Key Inclusion

  • Histologically confirmed gastroesophageal, pancreatic, or pan-tumor adenocarcinoma including invasive breast cancer (ER/PR+HER2-, ER/PR-HER2+, triple positive, or triple negative)
  • Tumor expresses CLDN18.2
  • Radiologically confirmed unresectable locally advanced or metastatic disease within 28 days prior to first dose
  • Received at least 1 line of therapy for unresectable locally advanced or metastatic disease
  • ECOG performance status of 0 or 1
  • Predicted life expectancy ≥12 weeks
  • Measurable disease per RECIST v1.1 (Cohorts 1-3) or evaluable disease (Cohort 4)
  • Adequate laboratory values within 14 days prior to first dose

Key Exclusion

  • Non-adenocarcinoma or mixed histology (Cohorts 1-3)
  • Received >2 prior lines of therapy for unresectable locally advanced or metastatic disease (Cohorts 1-3)
  • Symptomatic untreated brain metastases or meningeal carcinomatosis
  • Unresolved pneumonitis or history requiring glucocorticoids within 6 months
  • Active infection requiring systemic therapy not resolved within 7 days
  • Prior CLDN18.2 ADC treatment
  • Known peripheral neuropathy >grade 1
  • HER2 positive status (IHC 3+ or IHC 2+/ISH+) for gastroesophageal adenocarcinoma cohorts only

NCT07383649

Initial Safety Lead-in Followed by a Phase II Trial to Study Anti- HCMV Therapy in Breast Cancer Patients With Progressive Intracranial Metastases and CMV Infection (The Breast CMV Study)

Organization/Sponsor: The Methodist Hospital Research Institute


Example patient: A 52-year-old postmenopausal woman with metastatic breast cancer, ECOG status 1, presenting with multiple progressive brain metastases including at least one non-irradiated lesion ≤2 cm, positive CMV IgG serology, adequate organ function, and no immediate need for neurosurgical intervention.

Phase 2

Interventions

  • Drug: Valganciclovir
    Summary: A prodrug of ganciclovir that inhibits CMV DNA polymerase, suppressing viral replication; indicated for CMV retinitis in AIDS and CMV prevention in transplant recipients (FDA label, NCI Thesaurus).

Key Inclusion

  • Breast cancer with progressive brain metastases
  • At least one non-irradiated, untreated progressive brain metastases site
  • Serum HCMV DNA >250 copies/ml or positive CMV IgG or IgM
  • ECOG performance score 0-2
  • Adequate hematology (hemoglobin >9 g/dl, ANC >1500/mm3, platelets >100,000/mm3)
  • Adequate renal and hepatic function (CrCL >60 mL/min, bilirubin ≤1.5x ULN, AST/ALT ≤2.5x ULN)
  • Negative pregnancy test for premenopausal females
  • Age >18 years

Key Exclusion

  • Single resectable intracranial lesion
  • Last intracranial progression free survival >12 months
  • All progressive brain metastases have been radiated
  • Brain metastases needing immediate local intervention
  • Active pregnancy or breast feeding
  • Previous other malignancies without 3-year disease free interval
  • Major surgical procedure within 28 days
  • Non-English-speaking subjects

NCT07492641

An Open-Label, Randomized, Multicenter Phase 3 Study Investigating the Efficacy and Safety of BGB-43395 Plus Letrozole Versus CDK4/6 Inhibitors (Abemaciclib, Palbociclib, Ribociclib) Plus Letrozole in Patients With Advanced or Metastatic HR+/HER2- Breast Cancer Who Have Not Received Prior Systemic Anticancer Treatment for Advanced or Metastatic Disease Genomic-based

Organization/Sponsor: BeOne Medicines


Example patient: A 62-year-old postmenopausal woman with newly diagnosed metastatic hormone receptor-positive, HER2-negative breast cancer with liver metastases, ECOG performance status 1, adequate organ function, and no prior systemic therapy for metastatic disease.

Phase 3

Interventions

  • Drug: Ribociclib
    Summary: Ribociclib is a CDK4/6 inhibitor that blocks cyclin-dependent kinases 4 and 6 to arrest cell cycle progression in G1 phase, suppressing DNA synthesis and inhibiting cancer cell growth in hormone receptor-positive, HER2-negative breast cancer (FDA label, NCI Thesaurus).
  • Drug: Palbociclib
    Summary: Palbociclib selectively inhibits CDK4 and CDK6, preventing retinoblastoma protein phosphorylation and causing cell cycle arrest in G1 phase, thereby suppressing tumor cell proliferation in hormone receptor-positive, HER2-negative breast cancer (FDA label, NCI Thesaurus).
  • Drug: Abemaciclib
    Summary: Abemaciclib is a CDK4/6 inhibitor that blocks retinoblastoma protein phosphorylation in early G1 phase, arresting cell cycle and suppressing DNA synthesis in hormone receptor-positive, HER2-negative breast cancer (FDA label, NCI Thesaurus).
  • Drug: Letrozole
    Summary: Letrozole is a nonsteroidal aromatase inhibitor that blocks the enzyme catalyzing estrogen biosynthesis from androgens, reducing estrogen levels and inhibiting growth of estrogen-dependent breast cancer cells in postmenopausal women (FDA label, NCI Thesaurus).
  • Drug: BGB-43395
    Summary: BGB-43395 is a selective CDK4 inhibitor being studied for targeting cancer cell cycle progression in hormone receptor-positive, HER2-negative breast cancer and other solid tumors (Summary of Web Search).

Key Inclusion

  • At least 18 years of age or legal age of consent
  • Histologically confirmed locally advanced or metastatic HR+ HER2- breast cancer
  • ECOG Performance Status ≤ 1
  • Adequate organ function

Key Exclusion

  • Prior systemic treatment in the advanced or metastatic setting
  • Prior treatment with selective CDK4 or CDK2 targeting agent
  • Prior investigational anticancer drug except SERDs in adjuvant setting with recurrence >12 months after last dose
  • Active leptomeningeal disease
  • Uncontrolled, untreated brain metastasis

NCT07578571

A Phase 1 Study of IM-1617 in Participants With Advanced Malignancies Genomic-based

Organization/Sponsor: Immunome, Inc.


Example patient: A 58-year-old woman with metastatic triple-negative breast cancer, ECOG status 1, who has progressed on standard chemotherapy and immunotherapy, with measurable lung metastases and no prior ADC exposure.

Phase 1

Interventions

  • Drug: IM-1617
    Summary: IM-1617 is an antibody-drug conjugate with a topoisomerase-1 inhibitor payload targeting undisclosed receptors in advanced solid tumors including breast cancer. It is being evaluated for safety and efficacy in Phase 1 trials. Source: Summary of Web Search.

Key Inclusion

  • ECOG performance status 0, 1, or 2
  • Histologically confirmed unresectable locally advanced or metastatic solid tumors
  • Triple-negative breast cancer or HR+/HER2- breast cancer
  • Colorectal cancer (all subtypes) or NSCLC (squamous and non-squamous)
  • Progressed on or intolerant to prior standard of care treatments
  • Measurable disease per RECIST v1.1
  • Prior platinum-based chemotherapy and PD-1/PD-L1 therapy for NSCLC cohort
  • Prior fluoropyrimidine, oxaliplatin, irinotecan, and bevacizumab for CRC cohort

Key Exclusion

  • Previously treated with ADC containing TOP1 inhibitor payload (except up to one prior for NSCLC or breast cancer)
  • History of anaphylactic reaction to TOP1 inhibitors or TOP1 inhibiting ADCs
  • Life expectancy less than 12 weeks
  • Prior solid organ transplant
  • Symptomatic ascites or pleural effusion
  • Known active CNS metastases or carcinomatous meningitis
  • History of another primary malignancy within 2 years unless curative therapy with no recurrence

NCT07512271

Accuracy and Effect of Prescribed Generative AI Patient Education Module Within Breast Oncology Care

Organization/Sponsor: University of California, San Francisco


Example patient: A 52-year-old woman with newly diagnosed stage II hormone receptor-positive breast cancer, computer literate with home internet access, beginning adjuvant chemotherapy with regular oncology follow-up visits.

Phase N/A

Interventions

  • Behavioral: Survey (Provider)
    Summary: A data collection method involving questionnaires administered to a representative group of people, used to assess provider perspectives (NCI Thesaurus).
  • Device: OpenEvidence CareConnect
    Summary: A generative AI tool that matches breast cancer patients to relevant clinical trials based on disease characteristics and treatment history for patient education purposes (Web Search).
  • Behavioral: Survey (Participant)
    Summary: A data collection method involving questionnaires administered to a representative group of people, used to assess participant perspectives (NCI Thesaurus).

Key Inclusion

  • Females or males ages 18 and over
  • Stage IV breast cancer facing treatment change with follow-up every three months
  • Stage I-III breast cancer diagnosed within past 6 months
  • Basic computer literacy and regular internet access at home
  • Able to understand and comply with study procedures

Key Exclusion

  • Contraindication to any study-related procedure or assessment
  • Cognitive impairment interfering with tool usage or survey completion

NCT07458113

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

Organization/Sponsor: Yale University


Example patient: A 52-year-old woman with metastatic triple-negative breast cancer (ER 2%, PR 0%, HER2 0) who developed three new brain metastases (largest 15 mm) after completing prior treatment with sacituzumab govitecan, has ECOG performance status 1, adequate organ function, and no immediate need for brain radiation.

Phase N/A

Interventions

  • Drug: Sacituzumab tirumotecan
    Summary: An antibody-drug conjugate targeting TROP2-expressing cancer cells, delivering topoisomerase I inhibitor tirumotecan via a cleavable linker to induce DNA replication inhibition, cell cycle arrest, and apoptosis with bystander effect (NCI Thesaurus, FDA label).

Key Inclusion

  • Metastatic triple-negative breast cancer (ER <10%, PR <10%, HER2-negative)
  • Newly diagnosed or progressing brain metastases after prior local therapy
  • Intracranial measurable disease (≥10 mm contrast-enhancing lesion)
  • Prior treatment with antibody-drug conjugate required
  • ECOG performance status 0-1
  • Age ≥18 years
  • No immediate indication for surgery or radiation therapy
  • Adequate organ function and blood counts

Key Exclusion

  • Prior use of sacituzumab tirumotecan
  • Documented leptomeningeal disease by CSF cytology
  • Uncontrolled seizures (>2 seizures within 28 days)
  • Current Grade >2 pneumonitis or interstitial lung disease
  • QTcF interval >480 ms or significant cardiovascular disease within 6 months
  • Pregnant or lactating
  • Severe dry eye syndrome or corneal disease
  • Concurrent strong CYP3A4 inducers/inhibitors that cannot be discontinued

NCT07647328

SERAFA-1: A Single Arm, Open Label, Multicentre, Phase IIIb Study Of Camizestrant Plus Ribociclib in 1st Line Treatment of ER Positive, HER2-negative Advanced Breast Cancer Patients

Organization/Sponsor: AstraZeneca


Example patient: A 52-year-old postmenopausal woman with de novo Stage 4 ER-positive, HER2-negative metastatic breast cancer with liver and lung metastases, ECOG performance status 1, adequate organ function, who has not received any prior systemic therapy for metastatic disease.

Phase 3b

Interventions

  • Drug: Ribociclib
    Summary: Ribociclib is an orally available CDK4/6 inhibitor that blocks cyclin-dependent kinases 4 and 6, preventing Rb phosphorylation and arresting cell cycle in G1 phase, used for hormone receptor-positive, HER2-negative breast cancer (FDA label, NCI Thesaurus).
  • Drug: Camizestrant
    Summary: Camizestrant is an orally available selective estrogen receptor degrader (SERD) that binds ER causing conformational change and receptor degradation, inhibiting ER-mediated signaling in ER-expressing cancer cells, targeting ESR1 mutations (NCI Thesaurus, Web Search).

Key Inclusion

  • ER+, HER2- breast cancer not amenable to resection or radiation with curative intent
  • Previously untreated with systemic anti-cancer therapy for locoregionally recurrent or metastatic ER+ disease
  • De novo Stage 4 disease or recurrence after standard adjuvant endocrine therapy
  • At least 12 months elapsed since last adjuvant AI dose without progression
  • ECOG performance status 0 or 1
  • Adequate organ and marrow function
  • Female patients of childbearing potential must use highly effective contraception
  • Pre/peri-menopausal women amenable to monthly LHRH agonist treatment

Key Exclusion

  • Not clinically indicated for endocrine therapy with CDK4/6 inhibitor
  • No evidence of advanced inoperable disease or bone only disease with sclerotic lesions only
  • Advanced symptomatic visceral spread at risk of life-threatening complications or pulmonary lymphangitis
  • Persistent treatment-induced non-haematological toxicities CTCAE Grade >2
  • Known active infection including tuberculosis, HBV, HCV
  • Clinically important abnormalities in heart conduction patterns (pacemakers and controlled atrial fibrillation allowed)
  • Ongoing symptomatic hypotension
  • Pregnant or lactating women or unwilling to use highly effective contraception

NCT07427394

A Phase IIa, Open-label Study to Evaluate the Safety, Pharmacokinetics and Preliminary Efficacy of Camizestrant in Combination With Atirmociclib in Participants With ER-positive, HER2-negative Advanced Breast Cancer (SERENA-1b)

Organization/Sponsor: AstraZeneca


Example patient: A 58-year-old post-menopausal woman with ER-positive, HER2-negative metastatic breast adenocarcinoma who progressed on first-line CDK4/6 inhibitor plus aromatase inhibitor, has ECOG performance status 1, and has measurable lung metastases without life-threatening visceral involvement.

Phase 2

Interventions

  • Drug: Atirmociclib
    Summary: Atirmociclib is an orally bioavailable CDK4 inhibitor that selectively blocks CDK4-mediated phosphorylation of retinoblastoma protein, preventing G1-S phase transition and inhibiting tumor cell proliferation in HR-positive, HER2-negative metastatic breast cancer (NCI Thesaurus, Web Search).
  • Drug: Camizestrant
    Summary: Camizestrant is an orally available selective estrogen receptor degrader (SERD) that binds ER causing conformational change and receptor degradation, preventing ER-mediated signaling and inhibiting growth of ER-positive cancer cells, particularly those with ESR1 mutations (NCI Thesaurus, Web Search).

Key Inclusion

  • Advanced adenocarcinoma of the breast with prior adequate therapy
  • Metastatic or locoregionally recurrent disease with progression on last systemic therapy
  • ECOG/WHO performance status 0 to 1 with minimum 12 weeks life expectancy
  • At least one measurable or non-measurable lesion per RECIST 1.1
  • ER-positive tumor irrespective of progesterone receptor status
  • Pre-menopausal women must start GnRH agonist at least 4 weeks before treatment
  • Post-menopausal status confirmed by specific criteria
  • Histological or cytological confirmation of breast adenocarcinoma

Key Exclusion

  • Received 2 or more lines of CDK4/6 inhibitors in advanced disease setting
  • Prior camizestrant or atirmociclib treatment in advanced disease setting
  • Previously treated with next generation SERDs or experimental endocrine therapies in advanced setting
  • Previously treated with other experimental CDK inhibitors
  • Unresolved toxicities Grade 2 or higher from prior therapy except alopecia
  • Presence of life-threatening metastatic visceral disease
  • Inability to swallow oral medications
  • Contraindication or known intolerance to camizestrant or atirmociclib

NCT07604571

An Open-label, Multi-center, Phase I/Ib Study of IEV407 as a Single Agent and in Combination With Endocrine Therapy in Patients With Advanced Hormone Receptor Positive, HER2- Negative Breast Cancer Genomic-based

Organization/Sponsor: Novartis


Example patient: A 62-year-old postmenopausal woman with metastatic HR+/HER2- breast cancer who progressed on letrozole plus palbociclib as first-line therapy and has adequate organ function without cardiac disease or symptomatic visceral involvement.

Phase I, Phase Ib

Interventions

  • Drug: IEV407
    Summary: IEV407 is an investigational agent targeting the estrogen receptor in advanced HR+/HER2- breast cancer, tested as monotherapy and combined with endocrine therapies to assess safety and effectiveness (Summary of Web Search).
  • Drug: Fulvestrant
    Summary: Fulvestrant is an estrogen receptor antagonist that blocks and degrades estrogen receptors, inhibiting cancer cell growth in hormone receptor-positive, HER2-negative advanced breast cancer in postmenopausal women (FDA label, NCI Thesaurus).
  • Drug: Letrozole
    Summary: Letrozole is a nonsteroidal aromatase inhibitor that reduces estrogen production by inhibiting aromatase enzyme, used to treat hormone receptor-positive breast cancer in postmenopausal women (FDA label, NCI Thesaurus).

Key Inclusion

  • Age ≥ 18 years old
  • HR+/HER2- advanced breast cancer
  • Disease progression on or following endocrine therapy with CDK4/6 inhibitor
  • At least one line of endocrine-based therapy with CDK4/6 inhibitor
  • Dose escalation: at least one additional line of systemic therapy in metastatic setting
  • Dose expansion: no more than two prior lines of endocrine therapy in metastatic setting
  • Not a candidate for available standard therapy (dose escalation)
  • No prior cytotoxic chemotherapy or antibody-drug conjugates in metastatic setting (dose expansion)

Key Exclusion

  • Inadequate bone marrow or organ function with out-of-range laboratory values
  • Impaired cardiac function or clinically significant cardiac disease
  • Concurrent use of hormone replacement therapy
  • Women of childbearing potential unwilling to use highly effective contraception
  • Pregnant or nursing women
  • Symptomatic visceral disease for combination treatment
  • Disease burden making patient ineligible for endocrine-based therapy