Metastatic Breast Cancer Clinical Trials

70 studies are recruiting for metastatic breast cancer in the United States right now. Each one is listed on ClinicalTrials.gov, the public registry the research teams themselves file with. TrialBoost is not a doctor, a research site, or a study sponsor: the research team decides who takes part.

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Studies now recruiting

1. The CDK4/6 Inhibitor Dosing Knowledge (CDK) Study

   The purpose of this study is to generate evidence on an alternative dosing strategy for CDK4/6 inhibitors to help more patients with Metastatic Breast Cancer (MBC) (age ≥ 60 years) tolerate side effects and stay on treatment longer, to derive the most clinical benefit from these drugs. The primary …

   Stage

   Phase 3

   Ages

   60 and older

   Site

   Ironwood Cancer & Research Centers, Chandler, Arizona

   Locations

   92 in total

   Run by

   American Society of Clinical Oncology

   See if you can join NCT06377852 on ClinicalTrials.gov

2. Evaluation of Lasofoxifene Combined With Abemaciclib Compared With Fulvestrant Combined With Abemaciclib in Locally Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation

   The goal of this clinical trial is to assess the efficacy, safety and tolerability of the combination of lasofoxifene and abemaciclib compared to fulvestrant and abemaciclib for the treatment of pre- and postmenopausal women and men who have previously received ribociclib or palbociclib-based treat…

   Stage

   Phase 3

   Ages

   18 and older

   Site

   Mayo Clinic - Scottsdale, Scottsdale, Arizona

   Locations

   224 in total

   Run by

   LeonaBio

   See if you can join NCT05696626 on ClinicalTrials.gov

3. Beamion BCGC-1: A Study to Find a Suitable Dose of Zongertinib Used Alone and in Combination With Other Treatments to Test Whether it Helps People With Different Types of HER2+ Cancer That Has Spread

   This study is open to adults aged 18 years and older with different types of HER2+ cancer that has spread and cannot be removed by surgery. People can take part in this study if their tumours show HER2 aberrations and previous treatment was not successful. The purpose of this study is to find a sui…

   Stage

   Phase 1

   Ages

   18 and older

   Site

   The Oncology Institute of Hope and Innovation, Cerritos, California

   Locations

   104 in total

   Run by

   Boehringer Ingelheim

   See if you can join NCT06324357 on ClinicalTrials.gov

4. Prospective Evaluation Of High-Dose Systemic Methotrexate In Patients With Breast Cancer And Leptomeningeal Metastasis

   This study is a prospective evaluation of systemic, intravenous high-dose methotrexate (HD-MTX, 8 g/m2) in patients with triple negative, HER2-positive, and hormone refractory breast cancer with leptomeningeal metastasis (LMD) with or without brain parenchymal involvement.

   Stage

   Phase 2

   Ages

   18 and older

   Site

   Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland

   Locations

   3 in total

   Run by

   Wake Forest University Health Sciences

   See if you can join NCT02422641 on ClinicalTrials.gov

5. A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer

   This study will evaluate the efficacy and safety of inavolisib in combination with Phesgo (pertuzumab, trastuzumab, and rHuPH20 injection for subcutaneous use) compared with placebo in combination with Phesgo, as maintenance therapy, after induction therapy in participants with previously untreated…

   Stage

   Phase 3

   Ages

   18 and older

   Site

   Banner Health MD Anderson AZ, Gilbert, Arizona

   Locations

   192 in total

   Run by

   Hoffmann-La Roche

   See if you can join NCT05894239 on ClinicalTrials.gov

6. Prospective Registry of ADC as First- and Second-line Treatment for Breast Cancer

   Antibody-drug conjugates (ADCs) have demonstrated substantial improvement in progression free survival (PFS) and overall survival (OS) in phase III clinical trials in patients with metastatic triple negative breast cancer (mTNBC) and hormone receptor positive/HER2 negative (HR+/HER2-) metastatic br…

   Stage

   Not phased

   Ages

   18 and older

   Site

   University of California, San Francisco, San Francisco, California

   Locations

   3 in total

   Run by

   University of California, San Francisco

   See if you can join NCT06774027 on ClinicalTrials.gov

7. T-DXd Based Therapy Followed by Endocrine Therapy Plus Dual HER2 Blockade in First-line HER2+/ HR+ Metastatic Breast Cancer and Retreatment With T-DXd

   This study will evaluate a structured sequential treatment strategy starting with T-DXd + pertuzumab upfront therapy, followed by an optimized maintenance therapy with dual HER2+blockade + CDK4/6i + ET and the opportunity to retreat with T-DXd once patients progress under maintenance aimed to maxim…

   Stage

   Phase 3

   Ages

   18 and older

   Site

   Maryland Oncology Hematology, P.A., Columbia, Maryland

   Locations

   5 in total

   Run by

   Daiichi Sankyo

   See if you can join NCT07683754 on ClinicalTrials.gov

8. Anastrazole, Fulvestrant & Abemaciclib for HR+HER2- Metastatic Breast Cancer

   This is a phase 2, open-label, singled-arm clinical trial determining efficacy of combination therapy with anastrozole, fulvestrant and abemaciclib in subjects with breast cancer. These are subjects who are newly diagnosed advanced or metastatic hormone receptor positive breast cancer or subjects w…

   Stage

   Phase 2

   Ages

   18 and older

   Site

   Chao Family Comprehensive Cancer Center, University of California, Irvine, Orange, California

   Run by

   University of California, Irvine

   See if you can join NCT05524584 on ClinicalTrials.gov

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

   This is a dose escalation and dose expansion study to compare how well BGB-43395, a selective cyclin-dependent kinase 4 (CDK4) inhibitor, works as monotherapy or in combination with fulvestrant, letrozole, or elacestrant in participants with hormone receptor positive (HR+) and human epidermal growt…

   Stage

   Phase 1

   Ages

   18 and older

   Site

   Sarah Cannon Research Institute (Scri) At Health One, Denver, Colorado

   Locations

   61 in total

   Run by

   BeOne Medicines

   See if you can join NCT06120283 on ClinicalTrials.gov

10. A Clinical Study to Find the Optimal Dose of an Investigational Treatment Called BNT323 When Used in Combination With Another Investigational Treatment, BNT327, and to Test if That Combination Treatment is Safe and Beneficial for Patients With Advanced Breast Cancer

    This is a Phase I/II, multi-site, open-label, two-part study designed to evaluate the efficacy, safety, optimized dose and contribution of components of BNT323 (also known as trastuzumab pamirtecan and DB-1303) in combination with BNT327 (also known as pumitamig and PM8002) in participants with hor…

    Stage

    Phase 1

    Ages

    18 and older

    Site

    Beverly Hills Cancer Center, Beverly Hills, California

    Locations

    81 in total

    Run by

    BioNTech SE

    See if you can join NCT06827236 on ClinicalTrials.gov

11. Enhancing Access to Supportive Services for Women of Color With Metastatic Breast Cancer

    Black and Latina women experience disparities in supportive and palliative care access and outcomes. The goal of the proposed pilot study is to evaluate the feasibility and acceptability of a community navigator delivered supportive care intervention for historically underserved populations of wome…

    Stage

    Not phased

    Ages

    18 and older

    Site

    Mount Sinai Hospital, New York, New York

    Run by

    Icahn School of Medicine at Mount Sinai

    See if you can join NCT06405828 on ClinicalTrials.gov

12. A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer

    This is an umbrella study evaluating the efficacy and safety of multiple treatment combinations in participants with metastatic or inoperable locally advanced breast cancer. The study will be performed in two stages. During Stage 1, seven cohorts will be enrolled in parallel in this study: Cohort 1…

    Stage

    Phase 1

    Ages

    18 and older

    Site

    City of Hope - Duarte, Duarte, California

    Locations

    55 in total

    Run by

    Hoffmann-La Roche

    See if you can join NCT03424005 on ClinicalTrials.gov

13. BettER: Biomarker Driven Early Therapeutic Selection in Patients With HR+ HER2- Metastatic or Unresectable Breast Cancer

    This is a prospective study to assess the impact of biomarker driven, early therapeutic switching and delayed imaging with the incorporation of DiviTum® serum TK1 activity ("DiviTum® TKa") in patients with hormone receptor (HR) positive, HER-2 negative metastatic or unresectable breast cancer recei…

    Stage

    Not phased

    Ages

    18 and older

    Site

    Washington University School of Medicine, St Louis, Missouri

    Run by

    Washington University School of Medicine

    See if you can join NCT05977036 on ClinicalTrials.gov

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

    Phase 1b/2 open-label trial of 225Ac-DOTATATE (RYZ101) in subjects with ER+, HER2-negative unresectable or metastatic breast cancer expressing SSTRs.

    Stage

    Phase 1

    Ages

    Any age

    Site

    Research Facility, Omaha, Nebraska

    Locations

    31 in total

    Run by

    RayzeBio, Inc.

    See if you can join NCT06590857 on ClinicalTrials.gov

15. Phase 1 Study of OP-3136 in Advanced or Metastatic Solid Tumors

    This is a first-in-human, open-label, multicenter phase 1 study to evaluate safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of OP-3136, a lysine acetyltransferases 6A and 6B (KAT6A/B) inhibitor, as monotherapy and in combination with other anticancer age…

    Stage

    Phase 1

    Ages

    18 and older

    Site

    Banner MD Anderson Cancer Center, Gilbert, Arizona

    Locations

    25 in total

    Run by

    Olema Pharmaceuticals, Inc.

    See if you can join NCT06784193 on ClinicalTrials.gov

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

    This is a global, multicenter, open-label, randomized Phase 3 study comparing the efficacy and safety of RLY-2608 (zovegalisib) + fulvestrant to capivasertib + fulvestrant for the treatment of patients with HR+/HER2- ABC with PIK3CA mutation following recurrence or progression on or after treatment…

    Stage

    Phase 3

    Ages

    18 and older

    Site

    Banner MD Anderson Cancer Center, Gilbert, Arizona

    Locations

    243 in total

    Run by

    Relay Therapeutics, Inc.

    See if you can join NCT06982521 on ClinicalTrials.gov

17. A Study on Adding Precisely Targeted Radiation Therapy (Stereotactic Body Radiation Therapy) to the Usual Treatment Approach (Drug Therapy) in People With Breast Cancer

    The purpose of this study is to see if using Stereotactic Body Radiation Therapy/SBRT to treat a single metastatic site where cancer has worsened may be an effective treatment for people with oligometastatic breast cancer. Participants will stay on their usual drug therapy while they receive SBRT. …

    Stage

    Phase 2

    Ages

    18 and older

    Site

    Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities), Basking Ridge, New Jersey

    Locations

    8 in total

    Run by

    Memorial Sloan Kettering Cancer Center

    See if you can join NCT05534438 on ClinicalTrials.gov

18. A Study of Alisertib in Combination With Endocrine Therapy in Patients With HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer

    PUMA-ALI-1201 is a randomized, dose optimization, multicenter, Phase 2 study of alisertib administered in combination with endocrine therapy in participants with pathology-confirmed HR-positive/HER2-negative metastatic breast cancer (MBC) following progression on or after at least two prior lines o…

    Stage

    Phase 2

    Ages

    18 and older

    Site

    Alabama Oncology, Birmingham, Alabama

    Locations

    53 in total

    Run by

    Puma Biotechnology, Inc.

    See if you can join NCT06369285 on ClinicalTrials.gov

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

    First in human study to evaluate the safety, tolerability, and pharmacokinetics (PK) of BBO-10203, a PI3Kα:RAS breaker, alone and in combination with other anti-cancer agents in patients with advanced solid tumors.

    Stage

    Phase 1

    Ages

    18 and older

    Site

    City of Hope Comprehensive Cancer Center, Duarte, California

    Locations

    44 in total

    Run by

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

    See if you can join NCT06625775 on ClinicalTrials.gov

20. PRE-ISPY Phase I/II Oncology Platform Program

    PRE-ISPY Phase I/II (I-SPY-P1) is an open-label, multisite platform study with multiple ongoing drug regimen arms added by protocol amendment which is designed to evaluate single agents or combinations in locally advanced, incurable, or metastatic solid tumors and/or oligometastatic malignancy and/…

    Stage

    Phase 1

    Ages

    18 and older

    Site

    The University of Alabama at Birmingham O'Neal Comprehensive Cancer Center, Birmingham, Alabama

    Locations

    10 in total

    Run by

    QuantumLeap Healthcare Collaborative

    See if you can join NCT05868226 on ClinicalTrials.gov

21. Phase II Single Arm Trial of Low Dose Capecitabine in Patients With Advanced Breast Cancer

    This is a phase II study aiming at evaluating capecitabine prospectively at a dose of 1000 mg once daily in patients with advanced breast cancer who are ≥60 years of age, or frail at any age, with a greater risk of complications and poorer outcomes with other treatments.

    Stage

    Phase 2

    Ages

    60 and older

    Site

    University of Alabama at Birmingham, Birmingham, Alabama

    Run by

    University of Alabama at Birmingham

    See if you can join NCT06105684 on ClinicalTrials.gov

22. Evaluation of the Acceptability, Appropriateness, and Feasibility/Usability of a Metastatic Breast-cancer Specific Prognostic Calculator Among Clinicians

    I this qualitative study, Investigators will conduct semi-structured interviews with clinicians that are involved in the care of patients with breast cancer to evaluate the acceptability, appropriateness, and feasibility/usability of a metastatic breast cancer-specific prognostic tool. These interv…

    Stage

    Not phased

    Ages

    Any age

    Site

    University of North Carolina, Chapel Hill, North Carolina

    Run by

    UNC Lineberger Comprehensive Cancer Center

    See if you can join NCT05440929 on ClinicalTrials.gov

23. Group-based Comprehensive Lifestyle Program for Women With Metastatic Breast Cancer

    The research study is to learn how the ACLP can best support patients with stable HR+/HER2- MBC.

    Stage

    Not phased

    Ages

    18 and older

    Site

    The University of Texas M. D. Anderson Cancer Center, Houston, Texas

    Run by

    M.D. Anderson Cancer Center

    See if you can join NCT07179809 on ClinicalTrials.gov

24. Palazestrant in Combination With Ribociclib for the First-line Treatment of ER+/HER2- Advanced Breast Cancer

    This phase 3 clinical trial compares the efficacy and safety of palazestrant with ribociclib to letrozole and ribociclib in women and men who have not received prior systemic anti-cancer treatment for advanced breast cancer.

    Stage

    Phase 3

    Ages

    18 and older

    Site

    Clinical Trial Site, Hot Springs, Arkansas

    Locations

    200 in total

    Run by

    Olema Pharmaceuticals, Inc.

    See if you can join NCT07085767 on ClinicalTrials.gov

25. A Study of JNJ-101684362 (HLD-0117) in Patients With Metastatic Breast Cancer

    The purpose of this study is to find out the maximum tolerated dose (MTD) and/or recommended dose(s) for expansion (RDEs) of JNJ-101684362 (HLD-0117), to evaluate the safety of JNJ-101684362 (HLD-0117) , and how well the participants can tolerate it in Part 1 (dose escalation) of the study.

    Stage

    Phase 1

    Ages

    18 and older

    Site

    Yale University School Of Medicine, New Haven, Connecticut

    Locations

    6 in total

    Run by

    Janssen Research & Development, LLC

    See if you can join NCT07524855 on ClinicalTrials.gov