HER2-negative Breast Cancer Clinical Trials

36 studies are recruiting for her2-negative 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 Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)

   The Phase 2 monotherapy portion of this study is currently enrolling and will evaluate the efficacy and safety of PC14586 (INN rezatapopt) in participants with locally advanced or metastatic solid tumors harboring a TP53 Y220C mutation. The Phase 1 portion of the study will assess the safety, toler…

   Stage

   Phase 1

   Ages

   12 and older

   Site

   University of San Diego Moores Cancer Center, La Jolla, California

   Locations

   77 in total

   Run by

   PMV Pharmaceuticals, Inc

   See if you can join NCT04585750 on ClinicalTrials.gov

2. BGB-21447 (Bcl-2 Inhibitor) Combinations for Adults With Hormone-Receptor Positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Metastatic Breast Cancer

   This is a dose escalation and dose expansion study to assess the safety and tolerability of BGB-21447 (a B-cell leukemia/lymphoma 2 inhibitor, Bcl-2i) in combination with fulvestrant, with or without BGB-43395 (cyclin-dependent kinase 4 inhibitor, CDK4i), in adults with HR+/HER2- metastatic breast …

   Stage

   Phase 1

   Ages

   18 and older

   Site

   University of Iowa Hospitals and Clinics, Iowa City, Iowa

   Locations

   14 in total

   Run by

   BeOne Medicines

   See if you can join NCT06756932 on ClinicalTrials.gov

3. 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

   62 in total

   Run by

   BeOne Medicines

   See if you can join NCT06120283 on ClinicalTrials.gov

4. 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

   231 in total

   Run by

   Relay Therapeutics, Inc.

   See if you can join NCT06982521 on ClinicalTrials.gov

5. 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

6. Phase Ib Study of Axatilimab in Combination With Olaparib in BRCA1/2 and PALB2- Associated Metastatic HER2-negative Breast Cancer

   This research is being done to evaluate the safety and tolerability of the new drug, axatilimab, in combination with olaparib (a standard of care treatment) in Breast Cancer 1/2 genes (BRCA 1/2) and PALB2 associated HER2-negative metastatic breast cancer. The names of the study drugs involved in th…

   Stage

   Phase 1

   Ages

   18 and older

   Site

   Dana-Farber Cancer Institute, Boston, Massachusetts

   Locations

   2 in total

   Run by

   Dana-Farber Cancer Institute

   See if you can join NCT06488378 on ClinicalTrials.gov

7. TReatment of ADC-Refractory Breast CancEr With Dato-DXd or T-DXd: TRADE DXd

   The purpose of this study is to test the safety and effectiveness of the sequence of two investigational drugs (trastuzumab deruxtecan followed by datopotamab deruxtecan, or datopotamab deruxtecan followed by trastuzumab deruxtecan) to learn whether the treatment works in treating HER2-negative (HE…

   Stage

   Phase 2

   Ages

   18 and older

   Site

   University of Alabama, Birmingham, Alabama

   Locations

   11 in total

   Run by

   Ana C Garrido-Castro, MD

   See if you can join NCT06533826 on ClinicalTrials.gov

8. A Ph II Study of the TheraBionic P1 Device in Subjects With Hormone Positive Breast Cancer

   The goal of this clinical trial is to learn if the TheraBionic P1 device given to patients with advanced or metastatic HR positive, HER2 negative breast cancer who have progressed on standard of care options can affect patients survival. The main questions it aims to answer are: * will the TheraBio…

   Stage

   Not phased

   Ages

   22 and older

   Site

   Karmanos Cancer Institute at McLaren Bay Region, Bay City, Michigan

   Locations

   8 in total

   Run by

   Barbara Ann Karmanos Cancer Institute

   See if you can join NCT07227831 on ClinicalTrials.gov

9. Evaluation of PSMA in HER2- AR+ Metastatic Breast Cancer

   The purpose of this research is to determine the expression of prostate specific membrane antigen (PSMA) in human epidermal growth factor receptor 2 (HER2)-negative, androgen receptor (AR)-positive metastatic breast cancer, and to determine its role in resistance to the anti-androgen, bicalutamide.…

   Stage

   Phase 2

   Ages

   18 and older

   Site

   University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin

   Run by

   University of Wisconsin, Madison

   See if you can join NCT04573231 on ClinicalTrials.gov

10. DATO-BASE: DATOpotamab-deruxtecan for Breast Cancer Brain metAstaSEs

    The purpose of this study is to test the safety and effectiveness of the study drug datopotamab deruxtecan in participants with metastatic breast cancer that has spread to the brain. The name of the study drug used in this research study is: Datopotamab deruxtecan (a type of antibody-drug conjugate)

    Stage

    Phase 2

    Ages

    18 and older

    Site

    Miami Baptist Cancer Institute/, Miami, Florida

    Locations

    3 in total

    Run by

    Nancy Lin, MD

    See if you can join NCT06176261 on ClinicalTrials.gov

11. Study of RGT-490 in Patients With PIK3CA-Mutated Advanced Solid Tumors

    This is a phase 1/1b, open-label, multicenter study consisting of sequential parts designed to evaluate the safety, tolerability, and effects pharmacokinetic (PK) profile, and antitumor activity of RGT-490, an investigational oral therapy, in adults with locally advanced or metastatic solid tumors …

    Stage

    Phase 1

    Ages

    18 and older

    Site

    START Los Angeles, Los Angeles, California

    Locations

    5 in total

    Run by

    Regor Pharmaceuticals Inc.

    See if you can join NCT07524322 on ClinicalTrials.gov

12. Sacituzumab Govitecan In TNBC

    This research study is studying to evaluate sacituzumab govitecan for individuals with localized triple negative breast cancer (TNBC) The names of the study drugs involved in this study is: * Sacituzumab govitecan (SG) * Pembrolizumab (combination therapy with SG)

    Stage

    Phase 2

    Ages

    18 and older

    Site

    Dana Farber Cancer Institute, Boston, Massachusetts

    Locations

    5 in total

    Run by

    Massachusetts General Hospital

    See if you can join NCT04230109 on ClinicalTrials.gov

13. Ribociclib And Endocrine Treatment of Physician's Choice for Locoregional Recurrent, Resected Hormone Receptor Positive HER2 Negative Breast Cancer

    This is an open label, multicenter, single arm phase II study to evaluate the efficacy and safety of ribociclib and ET in patients with locoregional recurrence of HR-positive, HER2-negative breast cancer.

    Stage

    Phase 2

    Ages

    18 and older

    Site

    University of Alabama at Birmingham, Birmingham, Alabama

    Locations

    21 in total

    Run by

    Oana Danciu

    See if you can join NCT05467891 on ClinicalTrials.gov

14. CD40 Agonist, Flt3 Ligand, and Chemotherapy in HER2 Negative Breast Cancer

    This research study is being done to find out if the immunotherapy drugs called CDX-301 and CDX-1140 in combination with the standard chemotherapy treatment pegylated liposomal doxorubicin (PLD, Doxil) are safe and effective at controlling the cancer in patients with metastatic triple Human Epiderm…

    Stage

    Phase 1

    Ages

    18 to 99

    Site

    University of Chicago Comprehensive Cancer Center, Chicago, Illinois

    Locations

    7 in total

    Run by

    University of Texas Southwestern Medical Center

    See if you can join NCT05029999 on ClinicalTrials.gov

15. ERADICATE: A Phase Ib/II Study of Elacestrant Plus Trastuzumab Deruxtecan in Patients With CDK4/6 Inhibitor and Endocrine-resistant HR+/HER2-low or HER2-ultralow Metastatic Breast Cancer

    The goal of this study is to evaluate the safety and efficacy of elacestrant in combination with trastuzumab deruxtecan (T-DXd) in participants with hormone receptor-positive (HR+), HER2-low or HER2-ultralow, metastatic breast cancer that is resistant to prior CDK4/6 inhibitor and endocrine therapy…

    Stage

    Phase 1

    Ages

    18 and older

    Site

    Dana-Farber Cancer Institute, Boston, Massachusetts

    Run by

    Kristina A. Fanucci

    See if you can join NCT07198724 on ClinicalTrials.gov

16. Alpelisib/iNOS Inhibitor/Nab-paclitaxel in Patients With HER2 Negative Metaplastic Breast Cancer (MpBC)

    This is a research study to test the safety and effectiveness of using the drug alpelisib together with chemotherapy (nab-paclitaxel) and a drug called L-NMMA in patients with HER2 negative metastatic or locally advanced metaplastic breast cancer, who have not responded to previous treatments. Part…

    Stage

    Phase 2

    Ages

    18 and older

    Site

    National Institute of Health Clinical Center, Bethesda, Maryland

    Locations

    3 in total

    Run by

    The Methodist Hospital Research Institute

    See if you can join NCT05660083 on ClinicalTrials.gov

17. A Study of the Impact of Endocrine Therapy on Surgical Outcomes in People With Lobular Breast Cancer

    The purpose of this study is to look at how effective neoadjuvant (before surgery) endocrine therapy (NET) is in participants with invasive lobular carcinoma (ILC) who have breast-conserving surgery (BCS). The main purpose of the study is to see if NET reduces the chance of having cancer cells at t…

    Stage

    Phase 2

    Ages

    50 and older

    Site

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

    Locations

    7 in total

    Run by

    Memorial Sloan Kettering Cancer Center

    See if you can join NCT07483307 on ClinicalTrials.gov

18. DiviTum®TKa: A Biomarker Assay for Efficacy in HR+ Breast Cancer Patients

    This study is being done to determine if there is a pattern associated with response to endocrine therapy alone and in combination with CDK4/6 inhibitor used for hormone receptor positive HER2 negative breast cancer.

    Stage

    Not phased

    Ages

    18 and older

    Site

    Mayo Clinic in Florida, Jacksonville, Florida

    Run by

    Mayo Clinic

    See if you can join NCT06388122 on ClinicalTrials.gov

19. A Study of Abemaciclib and Radiation Therapy in People With Metastatic Breast Cancer

    The purpose of this study is to test different doses of abemaciclib to find the best dose in participants while receiving hormone therapy and radiation therapy.

    Stage

    Phase 1

    Ages

    18 and older

    Site

    Memorial Sloan Kettering at Basking Ridge (All protocol activities), Basking Ridge, New Jersey

    Locations

    7 in total

    Run by

    Memorial Sloan Kettering Cancer Center

    See if you can join NCT06678269 on ClinicalTrials.gov

20. Impact of Omitting Chemo Based on Patient's Selection for ER-Positive, HER2-Negative Breast Cancer With Ribociclib and Endocrine Therapy

    This is a Phase II, two-arm, single center, patient preference study designed to evaluate the impact of omitting adjuvant chemotherapy in moderate to high-anatomical risk, low-genomic risk (men or premenopausal women T2-3N0 and RS 16-25, or T1-3N1-2 and RS ≤ 25, and postmenopausal women T2-3N0 and …

    Stage

    Phase 2

    Ages

    18 and older

    Site

    Yale University, New Haven, Connecticut

    Run by

    Yale University

    See if you can join NCT06953882 on ClinicalTrials.gov

21. Study to Evaluate Biomarkers and Safety of Dapagliflozin Concomitant With Neoadjuvant Therapy

    The primary objective of the study is to assess metabolic plasma markers of insulin resistance in patients with early-stage HER2-negative breast cancers receiving dapagliflozin concomitant with neoadjuvant therapy.

    Stage

    Phase 1

    Ages

    18 and older

    Site

    Yale Cancer Center Smilow Cancer Hospital, New Haven, Connecticut

    Run by

    Yale University

    See if you can join NCT05989347 on ClinicalTrials.gov

22. I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer

    The purpose of this study is to further advance the ability to practice personalized medicine by learning which new drug agents are most effective with which types of breast cancer tumors and by learning more about which early indicators of response (tumor analysis prior to surgery via magnetic res…

    Stage

    Phase 2

    Ages

    18 and older

    Site

    University of Alabama at Birmingham, Birmingham, Alabama

    Locations

    42 in total

    Run by

    QuantumLeap Healthcare Collaborative

    See if you can join NCT01042379 on ClinicalTrials.gov

23. A Study of the TheraBionic P1 Device in Breast Cancer

    The goal of this clinical trial is to learn if adding cancer-specific amplitude-modulated radiofrequency electromagnetic field therapy (TheraBionic P1 device) to the treatment of resectable early-stage breast cancer will affect the pathological response.

    Stage

    Not phased

    Ages

    22 and older

    Site

    Karmanos Cancer Institute at McLaren Clarkston, Clarkston, Michigan

    Locations

    8 in total

    Run by

    Barbara Ann Karmanos Cancer Institute

    See if you can join NCT07218432 on ClinicalTrials.gov

24. 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

25. NearWave Optical Molecular Monitoring

    The purpose of this study is to assess the feasibility of the NearWave optical molecular monitoring system for monitoring therapy progression and predicting pathologic complete response (pCR) of breast cancer patients undergoing neoadjuvant chemotherapy (NAC).

    Stage

    Not phased

    Ages

    18 and older

    Site

    Indiana University Simon Comprehensive Cancer Center, Indianapolis, Indiana

    Run by

    Indiana University

    See if you can join NCT06744465 on ClinicalTrials.gov