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HER2-Negative Breast Cancer clinical trials
34 of 50 indexed HER2-Negative Breast Cancer trials are currently recruiting.
50 US clinical trials · 34 currently recruiting
HER2-Negative Breast Cancer is the subject of 50 registered US clinical trials on ClinicalTrials.gov, 34 of them currently open to new participants. 2 are in Phase 3-4 (later-stage) and 41 in Phase 1-2 (earlier-stage). The most active sponsor is Relay Therapeutics, running 3 of these trials.
The research picture
HER2-Negative Breast Cancer has 50 registered US clinical trials, 34 of them open to new participants right now, about 68% of the total.
- 34
- recruiting participants now
- 68%
- of trials open to enrollment
- 2
- in Phase 3–4 (later-stage)
- 3
- top sponsor: Relay Therapeutics
Active & Recent Trials
50 total, page 1 of 1
I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer
QuantumLeap Healthcare Collaborative
NCT01042379
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
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
A Study to Evaluate the Safety and Therapeutic Activity of GI-102 As a Single Agent and in Combination with Conventional Anti-cancer Drugs, Pembrolizumab or Trastuzumab Deruxtecan(T-DXd) in Patients with Advanced Solid Tumors (KEYNOTE-G08)
GI Innovation
NCT05824975
TReatment of ADC-Refractory Breast CancEr With Dato-DXd or T-DXd: TRADE DXd
Ana C Garrido-Castro, MD
NCT06533826
BGB-43395 Alone or as Part of Combination Therapies in Participants With Breast Cancer and Other Advanced Solid Tumors
BeiGene
NCT06120283
Role of the Immune Environment in Response to Therapy in Breast Cancer
Abramson Cancer Center at Penn Medicine
NCT05396612
Sacituzumab Govitecan In TNBC
Massachusetts General Hospital
NCT04230109
Ribociclib And Endocrine Treatment of Physician's Choice for Locoregional Recurrent, Resected Hormone Receptor Positive HER2 Negative Breast Cancer
Oana Danciu
NCT05467891
Phase 1b Study of OP-1250 (Palazestrant) in Combination With Ribociclib, Alpelisib, Everolimus, or Atirmociclib in ER+, HER2- Breast Cancer
Olema Pharmaceuticals
NCT05508906
A Study of the Impact of Endocrine Therapy on Surgical Outcomes in People With Breast Cancer
Memorial Sloan Kettering Cancer Center
NCT07483307
Impact of Omitting Chemo Based on Patient's Selection for ER-Positive, HER2-Negative Breast Cancer With Ribociclib and Endocrine Therapy
Yale University
NCT06953882
PRE-I-SPY Phase I/Ib Oncology Platform Program
QuantumLeap Healthcare Collaborative
NCT05868226
BGB-21447 (Bcl-2 Inhibitor) Combinations for Adults With Hormone-Receptor Positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Metastatic Breast Cancer
BeOne Medicines
NCT06756932
Breast Re-irradiation After Second Ipsilateral Lumpectomy
Youssef Zeidan
NCT06867484
DiviTum®TKa: A Biomarker Assay for Efficacy in HR+ Metastatic Breast Cancer Patients
Mayo Clinic
NCT06388122
Prospective Registry of ADC as First- and Second-line Treatment for Breast Cancer
University of California, San Francisco
NCT06774027
A Study of DR-0202 in Patients With Locally Advanced or Metastatic, Relapsed or Refractory Carcinomas
Dren Bio
NCT06999187
A Phase 2 Study of PCS6422 With Capecitabine in Patients With Advanced or Metastatic Breast Cancer
Processa Pharmaceuticals
NCT06568692
(Z)-Endoxifen for the Treatment of Premenopausal Women With ER+/HER2- Breast Cancer
Atossa Therapeutics
NCT05607004
DATO-BASE: DATOpotamab-deruxtecan for Breast Cancer Brain metAstaSEs
Sarah Sammons, MD
NCT06176261
Tirzepatide for Weight Loss Intervention in Early-Stage Hormone Receptor Positive/HER2 Negative Breast Cancer
Rutgers, The State University of New Jersey
NCT06518837
Alpelisib/iNOS Inhibitor/Nab-paclitaxel in Patients With HER2 Negative Metaplastic Breast Cancer (MpBC)
The Methodist Hospital Research Institute
NCT05660083
DecipHER Trial - DC1 Tx for Early-Stage TNBC and ER Low Positive Breast Cancer
H. Lee Moffitt Cancer Center and Research Institute
NCT05504707
CD40 Agonist, Flt3 Ligand, and Chemotherapy in HER2 Negative Breast Cancer
University of Texas Southwestern Medical Center
NCT05029999
Fulvestrant+Abemaciclib With Run-In of Fulvestrant in Er-Positive, Her2-Negative Metastatic Breast Cancer
The Methodist Hospital Research Institute
NCT05305924
A Study of Abemaciclib and Radiation Therapy in People With Metastatic Breast Cancer
Memorial Sloan Kettering Cancer Center
NCT06678269
A Study of the TheraBionic P1 Device in Breast Cancer
Barbara Ann Karmanos Cancer Institute
NCT07218432
Anastrazole, Fulvestrant & Abemaciclib for HR+HER2- Metastatic Breast Cancer
University of California, Irvine
NCT05524584
Phase Ib Study of Axatilimab in Combination With Olaparib in BRCA1/2 and PALB2- Associated Metastatic HER2-negative Breast Cancer
Dana-Farber Cancer Institute
NCT06488378
Study to Evaluate Biomarkers and Safety of Dapagliflozin Concomitant with Neoadjuvant Therapy
Yale University
NCT05989347
Immunologic Targeting of ESR1 Receptor for Hormone Receptor Expressing Metastatic Breast Cancer
H. Lee Moffitt Cancer Center and Research Institute
NCT06691035
NearWave Optical Molecular Monitoring
Indiana University
NCT06744465
Evaluation of PSMA in HER2- AR+ Metastatic Breast Cancer
University of Wisconsin, Madison
NCT04573231
Fulvestrant and/or Anastrozole in Treating Postmenopausal Patients With Stage II-III Breast Cancer Undergoing Surgery
Alliance for Clinical Trials in Oncology
NCT01953588
Safety and Efficacy Study of NUV-1511 in Adult Patients With Advanced Solid Tumors
Nuvation Bio
NCT06334432
Sacituzumab Govitecan +/- Pembrolizumab In HR+ / HER2 - MBC
Ana C Garrido-Castro, MD
NCT04448886
ZAP-IT: ZN-c3 + Carboplatin + Pembrolizumab in mTNBC
Filipa Lynce, MD
NCT06351332
Pegylated Liposomal Doxorubicin Hydrochloride and Carboplatin Followed by Surgery and Paclitaxel in Treating Patients With Triple Negative Stage II-III Breast Cancer
Rutgers, The State University of New Jersey
NCT02315196
Niraparib + Dostarlimab In BRCA Mutated Breast Cancer
Dana-Farber Cancer Institute
NCT04584255
Onvansertib + Paclitaxel In TNBC
Antonio Giordano, MD
NCT05383196
BYL719 and Letrozole in Post-Menopausal Patients With Hormone Receptor-Positive Metastatic Breast Cancer
Vanderbilt-Ingram Cancer Center
NCT01791478
Alpelisib (BYL719) in Combination With Continued Endocrine Therapy Following Progression on Endocrine Therapy in Hormone Receptor Positive, HER2 Negative, PIK3CA Mutant Metastatic Breast Cancer
Marina N Sharifi
NCT04762979
Monitoring Response to Neoadjuvant Chemotherapy in HER2 Negative Breast Cancer Using High-speed MR Spectroscopic Imaging
New Mexico Cancer Research Alliance
NCT03568448
Levels of Circulating Tumor DNA as a Predictive Marker for Early Switch in Treatment for Patients With Metastatic (Stage IV) Breast Cancer
University of Miami
NCT05826964
Trial of 225Ac-DOTATATE (RYZ101) in Subjects With ER+, HER2-negative Unresectable or Metastatic Breast Cancer Expressing SSTRs.
RayzeBio
NCT06590857
Neoadjuvant Endocrine Therapy in ER-positive, HER2-negative Early Stage Breast Cancer
Irada Ibrahim-zada
NCT05150652
First-in-Human Study of RLY-5836 in Advanced Breast Cancer and Other Solid Tumors
Relay Therapeutics
NCT05759949
Umbrella Trial of Subtype-Targeted Therapies in ER+/HER2- Breast Cancer
Jennifer Lee Caswell-Jin
NCT05101564
Carboplatin and Combination Chemotherapy With or Without Veliparib in Treating Patients With Stage IIB-IIIC Breast Cancer
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
NCT01818063
Phase Distribution
| Phase | Trial count |
|---|---|
| Phase 1 | 19 |
| Phase 2 | 22 |
| Phase 3 | 2 |
Top Sponsors
Source: ClinicalTrials.gov, National Library of Medicine. Data is informational only.
Reading the HER2-Negative Breast Cancer Trial Landscape
50 indexed HER2-Negative Breast Cancer studies · 34 recruiting (68%).
Phase mix: 2 late (III/IV) vs 41 early (I/II).
Top sponsor: Relay Therapeutics (3 trials), 9 others listed. 50 shown below, recruiting first.
How to read this condition's trial landscape
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.
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.
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 HER2-Negative Breast Cancer?
PlainTrial tracks 50 US clinical trials for HER2-Negative Breast Cancer, of which 34 are currently recruiting participants. Data sourced from ClinicalTrials.gov.
How do I find a recruiting trial for HER2-Negative 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
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.
Read our methodology - how this data is sourced, computed, and verified.
Source: ClinicalTrials.gov (NIH/NLM) ClinicalTrials.gov AACT registry · 2026 Trial counts and statuses sourced from ClinicalTrials.gov. Sponsor counts include both industry and federal/academic sponsors.
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page aggregates every registered trial for this condition, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.