HR+/HER2- Breast Cancer Clinical Trials

19 recruitingLast updated: June 18, 2026

There are 19 actively recruiting hr+/her2- breast cancer clinical trials across 16 countries. Studies span Phase 2, Phase 1, Phase 3. Top locations include Nashville, Tennessee, United States, Houston, Texas, United States, Cleveland, Ohio, United States. Updated daily from ClinicalTrials.gov.


HR+/HER2- Breast Cancer Trials at a Glance

19 actively recruiting trials for hr+/her2- breast cancer are listed on ClinicalTrialsFinder across 6 cities in 16 countries. The largest study group is Phase 2 with 11 trials, with the heaviest enrollment activity in Nashville, Houston, and Cleveland. Lead sponsors running hr+/her2- breast cancer studies include Novartis Pharmaceuticals, First Affiliated Hospital of Zhejiang University, and Avenzo Therapeutics, Inc..

Browse hr+/her2- breast cancer trials by phase

Treatments under study

About HR+/HER2- Breast Cancer Clinical Trials

Looking for clinical trials for HR+/HER2- Breast Cancer? There are currently 16 studies actively recruiting participants. Clinical trials offer access to new treatments before they are widely available, and every approved therapy in use today was first tested through a clinical trial.

Below you can browse trials, sign up for alerts when new HR+/HER2- Breast Cancer trials open, and view eligibility criteria for each study. Each listing includes the study phase, locations, and enrollment details.

Frequently Asked Questions

Common questions about HR+/HER2- Breast Cancer clinical trials

A clinical trial is a carefully designed research study that tests new medical treatments, drugs, devices, or approaches in human volunteers. Every approved medication and treatment available today was proven safe and effective through clinical trials.

All clinical trials are reviewed and approved by Institutional Review Boards (IRBs) — independent committees that evaluate patient safety. Trials follow strict protocols, and your health is monitored closely throughout. You can withdraw at any time.

Not necessarily. Many trials compare the new treatment against the current standard of care, meaning all participants receive active treatment. When placebos are used, they are typically combined with standard treatment, not given alone. The trial description will always specify the design.

Under the Affordable Care Act, most private insurers are required to cover routine patient care costs during a clinical trial. The sponsor typically covers the investigational treatment itself. Medicare also covers routine costs for qualifying trials.

Yes. Participation is completely voluntary. You can withdraw at any time, for any reason, without it affecting your access to standard medical care.

Each trial has specific eligibility criteria — including age, diagnosis, disease stage, prior treatments, and general health. Browse the trials listed above and check their eligibility sections. You can also contact the trial site directly to discuss your situation.

Showing 119 of 19 trials

Recruiting
Phase 3

BGB-43395 Plus Letrozole Versus CDK4/6i Plus Letrozole for Patients With Advanced or Metastatic HR+/HER2- Breast Cancer Who Have Not Received Prior Treatment for Advanced or Metastatic Disease

HR+/HER2- Breast Cancer
BeOne Medicines1,056 enrolled13 locationsNCT07492641
Recruiting
Phase 1

Study of IEV407 as Single Agent or in Combination in Patients With Advanced HR+/HER2- Breast Cancer

Advanced HR+/HER2- Breast Cancer
Novartis Pharmaceuticals194 enrolled2 locationsNCT07604571
Recruiting
Phase 1Phase 2

Study of GVV858 as a Single Agent or in Combination With Endocrine Therapy in Patients With HR+/HER2- Breast Cancer and Other Advanced Solid Tumors

Advanced HR+/HER2- Breast CancerAdvanced CCNE1-amplified Solid TumorsMetastatic Castration-resistant Prostate Cancer
Novartis Pharmaceuticals205 enrolled9 locationsNCT07288359
Recruiting
Phase 1

A Study With NKT5097 for Adults With Advanced/Metastatic Solid Tumors

Triple Negative Breast Cancer(TNBC)HR+ Breast CancerHR+/HER2- Breast Cancer+1 more
NiKang Therapeutics, Inc.361 enrolled14 locationsNCT07029399
Recruiting
Phase 2

Efficacy and Safety of Dalpiciclib Combined With Endocrine Adjuvant Therapy for Early HR +/HER2- Breast Cancer: a Multicenter, Prospective Clinical Study

Breast NeoplasmsBreast DiseasesCDK4/6 Inhibitor+3 more
Fujian Cancer Hospital2,000 enrolled2 locationsNCT07581834
Recruiting
Phase 3

Marker - Adjusted Therapy Comparing Adjuvant Elacestrant With Standard Endocrine Treatment in Genomically and/or Clinically High-risk ER+/HER2- eBC

Breast CancerHR+/HER2- Breast Cancer
West German Study Group1,520 enrolled1 locationNCT07242352
Recruiting
Phase 1Phase 2

ORION-1: Study of AVZO-023 as a Single Agent and in Combination With AVZO-021, and/or Endocrine Therapy in Advanced Solid Tumors

HR+/HER2- Advanced Breast CancerHR+/HER2- Breast Cancer
Avenzo Therapeutics, Inc.380 enrolled14 locationsNCT06998407
Recruiting
Phase 1Phase 2

Sapanisertib and Serabelisib (PIKTOR) in Various Combinations in Patients With HR+/HER2- Advanced/Metastatic Breast Cancer

HR+/HER2- Breast Cancer
Faeth Therapeutics32 enrolled3 locationsNCT07558733
Recruiting
Phase 1Phase 2

Study of ECI830 Single Agent or in Combination in Patients With Advanced HR+/HER2- Breast Cancer and Other Advanced Solid Tumors

Advanced HR+/HER2- Breast CancerAdvanced CCNE1-amplified Solid Tumors
Novartis Pharmaceuticals280 enrolled33 locationsNCT06726148
Recruiting
Phase 2

QL1706 for the Neoadjuvant Treatment of HR+/HER2- Breast Cancer

Breast CancerHR+/HER2- Breast Cancer
Henan Cancer Hospital238 enrolled1 locationNCT06967103
Recruiting

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

Metastatic Breast CancerHER2-Negative Breast CarcinomaHER2-negative Breast Cancer+3 more
University of California, San Francisco100 enrolled1 locationNCT06774027
Recruiting
Phase 1Phase 2

Study of AVZO-021 in Patients With Advanced Solid Tumors

Endometrial CancerAdvanced Solid TumorTNBC - Triple-Negative Breast Cancer+6 more
Avenzo Therapeutics, Inc.430 enrolled13 locationsNCT05867251
Recruiting
Phase 2

Neoadjuvant Chemotherapy in Combination With Anlotinib and Benmelstobart for HR+/HER2- Breast Cancer (NEOTORCH-BREAST03)

HR+/HER2- Breast Cancer
First Affiliated Hospital of Zhejiang University35 enrolled3 locationsNCT06874933
Recruiting
Phase 2

Neoadjuvant Chemotherapy in Combination With Toripalimab for HR+/HER2- Breast Cancer (NEOTORCH-BREAST01)

HR+/HER2- Breast Cancer
First Affiliated Hospital of Zhejiang University30 enrolled11 locationsNCT06611813
Recruiting
Phase 2

Serplulimab Combined With Chemotherapy for Early-stage HR+/HER2- Breast Cancer

HR+/HER2- Breast Cancer
Henan Cancer Hospital357 enrolled1 locationNCT06860529
Recruiting
Phase 3

Neoadjuvant Chemotherapy in Combination With Toripalimab for HR+/HER2- Breast Cancer : a Randomized, Open-label, Parallel-controlled, Multi-center Phase III Study (NEOTORCH-BREAST04)

HR+/HER2- Breast Cancer
First Affiliated Hospital of Zhejiang University194 enrolled13 locationsNCT06977893
Recruiting

Predicting clinicAL outcoMes During First-line CDK4/6 Inhibitors Plus Endocrine Therapy in Patients With Advanced Hormone REceptor-poSitive HER2-negative Breast Cancer: the Retrospective-prospective Multicenter Italian PALMARES-2 Study

Breast CancerBreast Cancer MetastaticBreast Carcinoma+37 more
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano3,500 enrolled24 locationsNCT06805812
Recruiting
Phase 1Phase 2

A Study of BPI-1178 in Patients With Advanced Solid Tumor and HR+/HER2- Breast Cancer

Advanced Solid TumorHR+/HER2- Breast Cancer
Beta Pharma (Suzhou) Co., Ltd.224 enrolled1 locationNCT04282031
Recruiting
Phase 3

Apatinib Combined With cdk4/6i in First-line Treatment for HR+/HER2- SNF4 Subtype Breast Cancer

Advanced Breast CancerHR+/HER2- Breast Cancer
Fudan University184 enrolled1 locationNCT06447623