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HER2-Negative Breast Cancer: early-phase trial registry
34 of 50 indexed HER2-Negative Breast Cancer trials are currently recruiting, with more weight in Phase 1-2.
Corpus placement: #277 of 28,707 conditions by registered trial count.
50 US clinical trials · 34 currently recruiting · #277 of 28,707 conditions by registered trial count
HER2-Negative Breast Cancer: 50 US clinical trials tracked, 34 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.
Enrollment posture brief
Registry condition her2-negative-breast-cancer
OPEN 34 | RECR 68% | LATE 2 | EARLY 41 | RANK #277 | SPON 3
Volume-matched condition peers
Nearest open-share peer: Heart Failure With Reduced Ejection Fraction (68% recruiting · 28 trials)
HER2-Negative Breast Cancer lists 34 open slots (68% of 50 indexed trials). Peers are matched on registered volume, not therapeutic-area browse lists. How peer matching works →
Key findings
What ClinicalTrials.gov does not surface for HER2-Negative Breast Cancer on its own pages , computed from the registry mirror as of 2026-08-08. Each line carries its own denominator so it can be quoted as it stands.
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HER2-Negative Breast Cancer is recruiting above its size-band peers.
34 of 50 indexed trials (68%) are open to enrollment, against a 39.7% average across 762 conditions with 20-99 trials. The peer set uses the same ClinicalTrials.gov-derived counts as this page.
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Sponsorship of HER2-Negative Breast Cancer trials is spread across many organizations.
Relay Therapeutics accounts for 3 of 50 trials (6%). 40 distinct sponsors appear on at least one study for this condition label.
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Most HER2-Negative Breast Cancer trials plan to enrol fewer than 100 people.
Median target enrolment is 62 among the 50 trials that report a genuine target (sentinel values excluded). 30 of those (60%) plan for fewer than 100 participants.
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HER2-Negative Breast Cancer research is mostly interventional.
46 interventional and 4 observational studies make up this index (92% interventional). Study type is sponsor-reported on ClinicalTrials.gov.
Open and 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
Named interventions
Most-linked intervention names on HER2-Negative Breast Cancer records (sponsor-reported on ClinicalTrials.gov). Counts are trial links, not unique products.
US sites by state
Facility locations filed on HER2-Negative Breast Cancer trials. A trial with sites in several states counts in each.
Source: ClinicalTrials.gov, National Library of Medicine. Data is informational only.
Related
What to do with this HER2-Negative Breast Cancer page
50 registered trials, 34 currently recruiting, is a starting point for a conversation, not a diagnosis or a recommendation.
- 34 HER2-Negative Breast Cancer trials are currently recruiting, check eligibility criteria before contacting a site. Browse recruiting trials
- Relay Therapeutics sponsors the most HER2-Negative Breast Cancer trials on record, review their full trial history before evaluating a specific study. See Relay Therapeutics's trials
- Bring the specific trial ID (NCT number) to your own doctor before enrolling, this page is a directory, not medical guidance. Read the trial-finding guide
Trial and recruiting counts reflect ClinicalTrials.gov registry status as of the data vintage above; individual trial eligibility and enrollment status can change.
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This HER2-Negative Breast Cancer condition card totals 50 registered trials; most-linked intervention Fulvestrant; top US site state Florida. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.