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ClinicalTrials.gov 34 recruiting now official registry

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
Phase 119Phase 222Phase 32

Active & Recent Trials

50 total, page 1 of 1

RECRUITING Phase 2 5,000 participants

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

QuantumLeap Healthcare Collaborative

NCT01042379

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 1 358 participants

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

RECRUITING Phase 2 357 participants

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

Ana C Garrido-Castro, MD

NCT06533826

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 300 participants

Role of the Immune Environment in Response to Therapy in Breast Cancer

Abramson Cancer Center at Penn Medicine

NCT05396612

RECRUITING Phase 2 260 participants

Sacituzumab Govitecan In TNBC

Massachusetts General Hospital

NCT04230109

RECRUITING Phase 2 200 participants

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

Oana Danciu

NCT05467891

RECRUITING Phase 1 190 participants

Phase 1b Study of OP-1250 (Palazestrant) in Combination With Ribociclib, Alpelisib, Everolimus, or Atirmociclib in ER+, HER2- Breast Cancer

Olema Pharmaceuticals

NCT05508906

RECRUITING Phase 2 176 participants

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

Memorial Sloan Kettering Cancer Center

NCT07483307

RECRUITING Phase 2 140 participants

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

Yale University

NCT06953882

RECRUITING Phase 1 124 participants

PRE-I-SPY Phase I/Ib Oncology Platform Program

QuantumLeap Healthcare Collaborative

NCT05868226

RECRUITING Phase 1 120 participants

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

RECRUITING NA 114 participants

Breast Re-irradiation After Second Ipsilateral Lumpectomy

Youssef Zeidan

NCT06867484

RECRUITING 100 participants

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

Mayo Clinic

NCT06388122

RECRUITING 100 participants

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

University of California, San Francisco

NCT06774027

RECRUITING Phase 1 96 participants

A Study of DR-0202 in Patients With Locally Advanced or Metastatic, Relapsed or Refractory Carcinomas

Dren Bio

NCT06999187

RECRUITING Phase 2 90 participants

A Phase 2 Study of PCS6422 With Capecitabine in Patients With Advanced or Metastatic Breast Cancer

Processa Pharmaceuticals

NCT06568692

RECRUITING Phase 2 87 participants

(Z)-Endoxifen for the Treatment of Premenopausal Women With ER+/HER2- Breast Cancer

Atossa Therapeutics

NCT05607004

RECRUITING Phase 2 58 participants

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

Sarah Sammons, MD

NCT06176261

RECRUITING Phase 2 40 participants

Tirzepatide for Weight Loss Intervention in Early-Stage Hormone Receptor Positive/HER2 Negative Breast Cancer

Rutgers, The State University of New Jersey

NCT06518837

RECRUITING Phase 2 36 participants

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

The Methodist Hospital Research Institute

NCT05660083

RECRUITING Phase 1 30 participants

DecipHER Trial - DC1 Tx for Early-Stage TNBC and ER Low Positive Breast Cancer

H. Lee Moffitt Cancer Center and Research Institute

NCT05504707

RECRUITING Phase 1 30 participants

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

University of Texas Southwestern Medical Center

NCT05029999

RECRUITING Phase 2 28 participants

Fulvestrant+Abemaciclib With Run-In of Fulvestrant in Er-Positive, Her2-Negative Metastatic Breast Cancer

The Methodist Hospital Research Institute

NCT05305924

RECRUITING Phase 1 28 participants

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

Memorial Sloan Kettering Cancer Center

NCT06678269

RECRUITING NA 24 participants

A Study of the TheraBionic P1 Device in Breast Cancer

Barbara Ann Karmanos Cancer Institute

NCT07218432

RECRUITING Phase 2 20 participants

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

University of California, Irvine

NCT05524584

RECRUITING Phase 1 20 participants

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

RECRUITING Phase 1 20 participants

Study to Evaluate Biomarkers and Safety of Dapagliflozin Concomitant with Neoadjuvant Therapy

Yale University

NCT05989347

RECRUITING Phase 1 18 participants

Immunologic Targeting of ESR1 Receptor for Hormone Receptor Expressing Metastatic Breast Cancer

H. Lee Moffitt Cancer Center and Research Institute

NCT06691035

RECRUITING NA 15 participants

NearWave Optical Molecular Monitoring

Indiana University

NCT06744465

RECRUITING Phase 2 13 participants

Evaluation of PSMA in HER2- AR+ Metastatic Breast Cancer

University of Wisconsin, Madison

NCT04573231

ACTIVE NOT RECRUITING Phase 3 1,473 participants

Fulvestrant and/or Anastrozole in Treating Postmenopausal Patients With Stage II-III Breast Cancer Undergoing Surgery

Alliance for Clinical Trials in Oncology

NCT01953588

ACTIVE NOT RECRUITING Phase 1 466 participants

Safety and Efficacy Study of NUV-1511 in Adult Patients With Advanced Solid Tumors

Nuvation Bio

NCT06334432

ACTIVE NOT RECRUITING Phase 2 110 participants

Sacituzumab Govitecan +/- Pembrolizumab In HR+ / HER2 - MBC

Ana C Garrido-Castro, MD

NCT04448886

ACTIVE NOT RECRUITING Phase 1 78 participants

ZAP-IT: ZN-c3 + Carboplatin + Pembrolizumab in mTNBC

Filipa Lynce, MD

NCT06351332

ACTIVE NOT RECRUITING Phase 2 62 participants

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

ACTIVE NOT RECRUITING Phase 2 62 participants

Niraparib + Dostarlimab In BRCA Mutated Breast Cancer

Dana-Farber Cancer Institute

NCT04584255

ACTIVE NOT RECRUITING Phase 1 50 participants

Onvansertib + Paclitaxel In TNBC

Antonio Giordano, MD

NCT05383196

ACTIVE NOT RECRUITING Phase 1 46 participants

BYL719 and Letrozole in Post-Menopausal Patients With Hormone Receptor-Positive Metastatic Breast Cancer

Vanderbilt-Ingram Cancer Center

NCT01791478

ACTIVE NOT RECRUITING Phase 2 44 participants

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

ACTIVE NOT RECRUITING 30 participants

Monitoring Response to Neoadjuvant Chemotherapy in HER2 Negative Breast Cancer Using High-speed MR Spectroscopic Imaging

New Mexico Cancer Research Alliance

NCT03568448

ACTIVE NOT RECRUITING Phase 2 24 participants

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

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

ACTIVE NOT RECRUITING Phase 2 8 participants

Neoadjuvant Endocrine Therapy in ER-positive, HER2-negative Early Stage Breast Cancer

Irada Ibrahim-zada

NCT05150652

COMPLETED Phase 1 41 participants

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

Relay Therapeutics

NCT05759949

COMPLETED Phase 2 19 participants

Umbrella Trial of Subtype-Targeted Therapies in ER+/HER2- Breast Cancer

Jennifer Lee Caswell-Jin

NCT05101564

COMPLETED Phase 2 9 participants

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

PhaseTrial count
Phase 1 19
Phase 2 22
Phase 3 2

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.

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 · 2026 Trial counts and statuses sourced from ClinicalTrials.gov. Sponsor counts include both industry and federal/academic sponsors.

Verify with NIH →

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.