TheraRadar
Landscape / Oncology
Data updated: Nov 12, 2026

HER2- Breast Cancer Clinical Trial Landscape

HER2- Breast Cancer is being studied across 181 clinical trials registered since 2008, with 122 programs currently active. The competitive pipeline includes 18 active Phase 3 trials, 81 active Phase 2 trials, and 19 active Phase 1 trials.

Top industry sponsors include AstraZeneca, Novartis, BeOne Medicines.

Trial activity

122 active / 181 total since 2008
Active by phase 18 Ph3 / 20 81 Ph2 / 119 19 Ph1 / 37 4 Ph4 / 5

Sponsor activity

Who is running trials now — green active, blue completed, red failed/terminated.

Sorted by active Active Done Failed
AstraZeneca 4 2 0
Novartis 3 1 1
BeOne Medicines 3 1 0
Olema Pharmaceuticals, Inc. 2 1 0
Avenzo Therapeutics, Inc. 2 0 0
Relay Therapeutics, Inc. 1 1 0
Faeth Therapeutics 1 0 0
SynDevRx, Inc. 1 0 0
Totus Medicines 1 0 0
Sichuan Baili Pharmaceutical Co., Ltd. 1 0 0
Pfizer 1 0 0
RayzeBio, Inc. 1 0 0
PMV Pharmaceuticals, Inc 1 0 0
NiKang Therapeutics, Inc. 1 0 0
Monte Rosa Therapeutics, Inc 1 0 0

All 15 active HER2- Breast Cancer sponsors

Unlock the remaining 7 sponsors with active / completed / failed counts — sortable and exportable.

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How the field has grown

New-trial starts peaked in 2024 (29 registered); 2025 saw 22. The right-hand chart shows median Phase 3 enrollment by start year — the number in parentheses is that year's Phase 3 trial count (18 in total), so single-trial years (and years with no Phase 3 starts) are obvious. Both are by trial start date; the current year is partial.

New trials started by year

2016
2
2017
3
2018
1
2019
2
2020
14
2021
15
2022
22
2023
18
2024
29
2025
22
2026
26

TheraRadar.com

Median Phase 3 enrollment by start year

2016 (0)
0
2017 (0)
0
2018 (0)
0
2019 (0)
0
2020 (2)
796
2021 (2)
843
2022 (0)
0
2023 (3)
71
2024 (4)
342
2025 (2)
222
2026 (5)
1,500

TheraRadar.com

Full trial pipeline

Every active and completed trial across Phase 1–4, with enrollment analytics. Sortable, filterable, exportable with Pro.

NCT07242352 RECRUITING
Marker - Adjusted Therapy Comparing Adjuvant Elacestrant With Standard Endocrine Treatment in Genomically and/or Clinically High-risk ER+/HER2- eBC
Women's Cancer Study Group GmbH n=1,520
NCT07492641 RECRUITING
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
BeOne Medicines n=1,056
NCT04595565 ACTIVE NOT RECRUITING
Sacituzumab Govitecan in Primary HER2-negative Breast Cancer
GBG Forschungs GmbH n=1,332
NCT04964934 ACTIVE NOT RECRUITING
Phase III Study to Assess AZD9833+ CDK4/6 Inhibitor in HR+/HER2-MBC With Detectable ESR1m Before Progression (SERENA-6)
AstraZeneca n=315
NCT06343948 ACTIVE NOT RECRUITING
A Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Unresectable Locally Advanced, Recurrent, or Metastatic HR+HER2- Breast Cancer(PANKU-Breast01)
Sichuan Baili Pharmaceutical Co., Ltd. n=383
NCT06382948 RECRUITING
Elacestrant + Everolimus in Patients ER+/HER2-, ESR1mut, Advanced Breast Cancer Progressing to ET and CDK4/6i.
MedSIR n=300
NCT07106632 RECRUITING
Optimising Adjuvant Chemotherapy Prescription in Young Patients With Hormone-dependent Breast Cancer Using Genomic Tests
UNICANCER n=3,380
NCT07281833 RECRUITING
Phase III Study to Evaluate the Safety, Efficacy, and Impact on Quality of Life of Capivasertib Alongside Standard-of-care Endocrine Treatment in Patients With HR+/HER2- Advanced Breast Cancer and Progression on Prior Endocrine-based Treatment
Women's Cancer Study Group GmbH n=250
NCT01953588 ACTIVE NOT RECRUITING
Fulvestrant and/or Anastrozole in Treating Postmenopausal Patients With Stage II-III Breast Cancer Undergoing Surgery
Alliance for Clinical Trials in Oncology n=1,473
NCT04711252 ACTIVE NOT RECRUITING
A Comparative Study of AZD9833 Plus Palbociclib Versus Anastrozole Plus Palbociclib in Patients With ER-Positive HER2 Negative Breast Cancer Who Have Not Received Any Systemic Treatment for Advanced Disease
AstraZeneca n=1,371
NCT05512364 RECRUITING
Elacestrant for Treating ER+/HER2- Breast Cancer Patients With ctDNA Relapse (TREAT ctDNA)
European Organisation for Research and Treatment of Cancer - EORTC n=220
NCT06977893 RECRUITING
Neoadjuvant Chemotherapy in Combination With Toripalimab for HR+/HER2- Breast Cancer : a Randomized, Open-label, Parallel-controlled, Multi-center Phase III Study (NEOTORCH-BREAST04)
First Affiliated Hospital of Zhejiang University n=194
NCT05889390 ACTIVE NOT RECRUITING
Neoadjuvant Concomitant Modulated Electro-hyperthermia in HER2-negative Breast Cancer
Semmelweis University n=71
NCT06407401 NOT YET RECRUITING
Improvement of Quality of Life Through Supportive Treatments for Hormone Therapy - Related Symptoms in Patients With Early Breast Cancer
European Organisation for Research and Treatment of Cancer - EORTC n=399
NCT06447623 ACTIVE NOT RECRUITING
Apatinib Combined With cdk4/6i in First-line Treatment for HR+/HER2- SNF4 Subtype Breast Cancer
Fudan University n=184
NCT04576143 RECRUITING
Efficacy and Safety of Dose-dense Chemotherapy (ddEC-ddP) for Neoadjuvant Chemotherapy of HER2-negative Breast Cancer
Second Affiliated Hospital, School of Medicine, Zhejiang University n=260
NCT07647328 RECRUITING
A Phase IIIb Study to Evaluate Camizestrant Plus Ribociclib in ER-positive, HER2-negative Advanced Breast Cancer
AstraZeneca n=150
NCT07827573 RECRUITING
A Study to Learn How Well Participants With a Specific Type of Early Breast Cancer (ER-Positive, HER2-Negative) Tolerate and Stay on Treatment With Giredestrant and How They Feel During Treatment
Hoffmann-La Roche n=1,500
NCT05503108 SUSPENDED
Fasting Mimicking Diet Program to ImpRovE ChemoTherapy in Hormone Receptor Postive (HR+), HER2- Breast Cancer
Leiden University Medical Center n=10
NCT02225470 COMPLETED
Eribulin Versus Vinorelbine in Subjects With Locally Recurrent or Metastatic Breast Cancer Previously Treated With Anthracyclines and Taxanes
Eisai Co., Ltd. n=530

Full HER2- Breast Cancer Pipeline

Every trial across Phase 1–4, plus enrollment analytics. Sortable, filterable, exportable.

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Data: ClinicalTrials.gov · Trials registered 2008 onwards · Industry sponsors only