Medical Information Only. Consult your healthcare provider before considering clinical trial enrollment.

2026 data Public-data reference. official source

Advanced Breast Cancer

Open-data reference.

29 US clinical trials · 18 currently recruiting

Active & Recent Trials

RECRUITING Phase 1 930 participants

First-in-Human Study of Mutant-selective PI3Kα Inhibitor, RLY-2608, as a Single Agent in Patients With Advanced Solid Tumors and in Combination With Endocrine Therapy +/- a CDK4/6 or CDK4 Inhibitor in Patients With Advanced Solid Tumors or Advanced Breast Cancer

Relay Therapeutics

NCT05216432

RECRUITING Phase 3 540 participants

Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancer

Relay Therapeutics

NCT06982521

RECRUITING Phase 3 510 participants

OP-1250 (Palazestrant) vs. Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer

Olema Pharmaceuticals

NCT06016738

RECRUITING Phase 3 500 participants

Saruparib (AZD5305) Plus Camizestrant Compared With CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant in HR-Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified), BRCA1, BRCA2, or PALB2m Advanced Breast Cancer

AstraZeneca

NCT06380751

RECRUITING Phase 1 392 participants

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)

NCT06625775

RECRUITING Phase 1 300 participants

BGB-43395 Alone or as Part of Combination Therapies in Participants With Breast Cancer and Other Advanced Solid Tumors

BeiGene

NCT06120283

RECRUITING Phase 1 260 participants

A Study to Learn About the Study Medicine Called PF-08032562 in People With Advanced or Metastatic Solid Tumors

Pfizer

NCT07318805

RECRUITING NA 260 participants

Prolonged Overnight Fasting and/or Exercise on Fatigue and Other Patient Reported Outcomes in Women With Hormone Receptor Positive Advanced Breast Cancer

University of Miami

NCT06123988

RECRUITING Phase 1 240 participants

A First-in-Human Study of MEN2312 in Adults With Advanced Breast Cancer

Stemline Therapeutics

NCT06638307

RECRUITING Phase 1 234 participants

A Phase 1 Study of BMS-986500 as Monotherapy or Combination Therapy in Advanced Solid Tumors

Bristol-Myers Squibb

NCT06997029

RECRUITING Phase 1 233 participants

Phase 1/2 Study of ETX-636 in Participants With Advanced Solid Tumors

Ensem Therapeutics

NCT06993844

RECRUITING NA 200 participants

The COMPASSION Study

Dana-Farber Cancer Institute

NCT06507930

RECRUITING NA 190 participants

Engage Psychosocial Intervention for Cancer Symptoms

Duke University

NCT06555588

RECRUITING Phase 2 172 participants

A Study of Disitamab Vedotin With Other Anticancer Drugs in Solid Tumors

Seagen, a wholly owned subsidiary of Pfizer

NCT06157892

RECRUITING Phase 2 135 participants

Genetically-informed Therapy for ER+ Breast Cancer Post-CDK4/6 Inhibitor

Dartmouth-Hitchcock Medical Center

NCT05933395

RECRUITING Phase 1 116 participants

Metarrestin (ML-246) in Subjects With Metastatic Solid Tumors

National Cancer Institute (NCI)

NCT04222413

RECRUITING Phase 1 96 participants

Study of the Kinesin Oral Molecular Degrader BBI-940 in Subjects With Advanced or Metastatic Breast Cancer

Boundless Bio

NCT07408089

RECRUITING Phase 2 75 participants

Sequencing Antibody Drug Conjugates in ER+/HER2 LOW/ULTRA LOW MBC

Reshma L. Mahtani, D.O.

NCT06263543

ACTIVE NOT RECRUITING 6,097 participants

Emulation of the PALOMA-2 Trial

Brigham and Women's Hospital

NCT07178743

ACTIVE NOT RECRUITING Phase 3 624 participants

A Study to Learn About a New Medicine Called Vepdegestrant (ARV-471, PF-07850327) in People Who Have Advanced Metastatic Breast Cancer

Pfizer

NCT05654623

ACTIVE NOT RECRUITING Phase 1 500 participants

A Study of LY3484356 in Participants With Advanced or Metastatic Breast Cancer or Endometrial Cancer

Eli Lilly and Company

NCT04188548

ACTIVE NOT RECRUITING Phase 2 60 participants

RCT of CBD for Anxiety in Advanced Breast Cancer

Dana-Farber Cancer Institute

NCT04482244

ACTIVE NOT RECRUITING Phase 2 48 participants

Secondary BRain Metastases Prevention After Isolated Intracranial Progression on Trastuzumab/Pertuzumab or T-DM1 in Patients With aDvanced Human Epidermal Growth Factor Receptor 2+ brEast Cancer With the Addition of Tucatinib

Carey Anders, M.D.

NCT05323955

ACTIVE NOT RECRUITING Phase 1 16 participants

Trial of 225Ac-DOTATATE (RYZ101) in Subjects With ER+, HER2-negative Unresectable or Metastatic Breast Cancer Expressing SSTRs.

RayzeBio

NCT06590857

COMPLETED Phase 2 103 participants

A Study to Assess the Efficacy and Safety of Enzalutamide With Trastuzumab in Patients With Human Epidermal Growth Factor Receptor 2 Positive (HER2+), Androgen Receptor Positive (AR+) Metastatic or Locally Advanced Breast Cancer

Astellas Pharma Global Development

NCT02091960

COMPLETED Phase 2 100 participants

Randomized Trial of Fulvestrant With or Without Dasatinib in Men and Postmenopausal Women Who Have Hormone Receptor-positive Advanced Breast Cancer Previously Treated With an Aromatase Inhibitor

Bristol-Myers Squibb

NCT00754325

COMPLETED Phase 1 41 participants

First-in-Human Study of RLY-5836 in Advanced Breast Cancer and Other Solid Tumors

Relay Therapeutics

NCT05759949

COMPLETED NA 29 participants

Feasibility of a Team Approach for Discussing Prognosis and Treatment Goals in Breast Cancer

Case Comprehensive Cancer Center

NCT01876238

COMPLETED Phase 1 9 participants

HOPE: Olaparib, Palbociclib and Fulvestrant in Patients With BRCA Mutation-associated, HR+, HER2-metastatic Breast Cancer

Abramson Cancer Center at Penn Medicine

NCT03685331

Phase Distribution

PhaseTrial count
Early Phase 1 13
Phase 2 7
Phase 3 4

Source: ClinicalTrials.gov, National Library of Medicine. Data is informational only.

Reading the Advanced Breast Cancer Trial Landscape

ClinicalTrials.gov lists 29 US studies indexed under Advanced Breast Cancer, and 18 of those are currently open to recruitment — roughly 62% of the total volume on the registry. That ratio is a useful proxy for activity level: a high share of recruiting studies often signals that research interest is current and that new enrollment opportunities are appearing, while a low share typically means the field is dominated by completed or follow-up work where most participant spots have already been filled. These counts reflect the public registry only and include studies at every stage of design, so they should be read as an index of research attention rather than as a measure of treatment availability.

The phase distribution for Advanced Breast Cancer shows 4 late-stage studies (Phase 3 and Phase 4 combined) alongside 20 earlier-phase entries (Phase 1 through Phase 2). Phase 1 and Phase 2 studies focus on early safety signals, dosing, and preliminary effect, while Phase 3 studies are typically the larger efficacy and safety trials submitted toward regulatory review, and Phase 4 studies follow approved interventions in real-world use. A condition weighted toward later phases often reflects a mature research pipeline with several interventions already close to or past approval, whereas a heavier early-phase tilt suggests the field is still exploring new mechanisms and candidate approaches.

Top sponsor activity for Advanced Breast Cancer is led by Relay Therapeutics with 3 indexed trials, alongside 9 other organizations in the top contributor list. The list on this page surfaces up to 29 of the most relevant recent and active entries, ordered with recruiting studies first so practical options are visible. All figures are derived from the public ClinicalTrials.gov dataset maintained by the National Library of Medicine and are reproduced here for reference. Inclusion of a trial, sponsor, or intervention on this page is neither an endorsement nor a recommendation — eligibility, protocol changes, and site-level status can shift frequently, so always verify current details on ClinicalTrials.gov and consult a qualified healthcare provider before acting on anything you see here.

Frequently Asked Questions

How many clinical trials are there for Advanced Breast Cancer?

PlainTrial tracks 29 US clinical trials for Advanced Breast Cancer, of which 18 are currently recruiting participants. Data sourced from ClinicalTrials.gov.

How do I find a recruiting trial for Advanced Breast Cancer?

Use the trial list above filtered by "Recruiting" status, or visit our trial finder at /recruiting to search by condition and state. Always discuss trial participation with your healthcare provider before enrolling.

Is this data current?

Data is sourced from ClinicalTrials.gov and reflects our most recent data pull. Trial status may have changed since then. Always verify current information at ClinicalTrials.gov before making decisions about participation.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Disclaimer: This information is provided for informational purposes only and does not constitute professional advice. Data is sourced from ClinicalTrials.gov (National Library of Medicine). Consult a qualified professional before making decisions based on this data.

Source: ClinicalTrials.gov (NIH/NLM) ClinicalTrials.gov AACT registry · 2024 Trial counts and statuses sourced from ClinicalTrials.gov. Sponsor counts include both industry and federal/academic sponsors.

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