TheraRadar
Landscape Oncology

HER2- Breast Cancer Clinical Trial Landscape

Data updated: May 20, 2026

171 clinical trials tracked since 2008

HER2- Breast Cancer is being studied across 171 clinical trials registered since 2008, with 120 programs currently active. The competitive pipeline includes 16 active Phase 3 trials, 82 active Phase 2 trials, and 39 active Phase 1 trials. Top industry sponsors include AstraZeneca, Novartis, BeOne Medicines.

120 active
/
171 total (since 2008)
39
Phase 1 Active
61 total
82
Phase 2 Active
116 total
16
Phase 3 Active
18 total
4
Phase 4 Active
5 total

Top Industry Sponsors

Sorted by active Active Done Failed
AstraZeneca 3 2 0
Novartis 3 1 0
BeOne Medicines 3 0 0
Olema Pharmaceuticals, Inc. 2 1 0
Avenzo Therapeutics, Inc. 2 0 0

+ 10 more sponsors — see full table below

Featured Phase 3 Trials

NCT07242352 RECRUITING
Marker - Adjusted Therapy Comparing Adjuvant Elacestrant With Standard Endocrine Treatment in Genomically and/or Clinically High-risk ER+/HER2- eBC
West German Study Group n=1,520
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=240

+ 13 more Phase 3 trials — see full database below

HER2- Breast Cancer — Trials Started by Year (last 10 years)

2016
2
2017
3
2018
1
2019
2
2020
15
2021
13
2022
22
2023
18
2024
29
2025
22
2026
17

TheraRadar.com

Full Trial Database

Complete sponsor table, every trial across all phases, plus competitive analytics. Sortable, filterable, exportable for Pro users.

Top Sponsors (all-time)

AstraZeneca
5
Novartis
4
BeOne Medicines
3
Olema Pharmaceuticals, Inc.
3
Avenzo Therapeutics, Inc.
2
Relay Therapeutics, Inc.
2
BeiGene
2
Faeth Therapeutics
1
SynDevRx, Inc.
1
Totus Medicines
1

Active Trials by Phase

Phase 1
39
Phase 2
82
Phase 3
16
Phase 4
4

Enrollment Size Distribution

1-50
64
51-200
55
201-500
33
501-1k
6
1k+
9

All Industry Sponsors

Sorted by active Active Done Failed
AstraZeneca 3 2 0
Novartis 3 1 0
BeOne Medicines 3 0 0
Olema Pharmaceuticals, Inc. 2 1 0
Avenzo Therapeutics, Inc. 2 0 0
Relay Therapeutics, Inc. 1 1 0
BeiGene 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
NCT07242352 RECRUITING
Marker - Adjusted Therapy Comparing Adjuvant Elacestrant With Standard Endocrine Treatment in Genomically and/or Clinically High-risk ER+/HER2- eBC
West German Study Group n=1,520
NCT07492641 NOT YET 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=240
NCT07106632 NOT YET 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
West German Study Group 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=1,370
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 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
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 sponsor, every trial across Phase 1–4. Sortable, filterable, exportable.

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