HER2-positive Breast Cancer

Oncology
15
Pipeline Programs
16
Companies
22
Clinical Trials
8 recruiting
0
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
3
2
8
0
2
0
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Monoclonal Antibody
764%
ADC
327%
Small Molecule
19%
+ 12 programs with unclassified modality

Competitive Landscape

15 companies ranked by most advanced pipeline stage

CT
2 programs
2
TQB2102 for injectionPhase 31 trial
TQB2440 injection + Trastuzumab + DocetaxelPhase 31 trial
Active Trials
NCT07043725RecruitingEst. Sep 2029
NCT05985187UnknownEst. Dec 2023
DS
Daiichi SankyoChina - Shanghai
5 programs
1
Trastuzumab deruxtecanPhase 2ADC1 trial
Electronic medical record and hospital information system or other available resourcesN/A1 trial
No drugN/A1 trial
Trastuzumab deruxtecanN/AADC1 trial
Trastuzumab deruxtecanN/AADC1 trial
Active Trials
NCT05769751Completed865Est. Jul 2023
NCT06833268Completed228Est. Jun 2025
NCT06210776Recruiting800Est. Mar 2028
+2 more trials
Roche
RocheSTAVANGER NORWAY, Norway
2 programs
2
InavolisibPhase 2Small Molecule1 trial
Trastuzumab and pertuzumab Subcutaneous Fixed-Dose CombinationPhase 21 trial
Active Trials
NCT05306041Recruiting170Est. Jan 2027
NCT04578106Terminated5Est. Jul 2024
Genentech
GenentechCA - Oceanside
2 programs
2
PertuzumabPhase 2Monoclonal Antibody
Pertuzumab+TRASTUZUMABPhase 2Monoclonal Antibody1 trial
Active Trials
NCT04569747Recruiting375Est. Sep 2030
E
EisaiChina - Liaoning
1 program
1
PertuzumabPhase 2Monoclonal Antibody1 trial
Active Trials
NCT01912963Terminated32Est. Dec 2016
Jazz Pharmaceuticals
Jazz PharmaceuticalsCA - Palo Alto
1 program
1
ZanidatamabPhase 2Monoclonal Antibody1 trial
Active Trials
NCT07102381Recruiting125Est. Aug 2030
City Therapeutics
City TherapeuticsMA - Cambridge
1 program
1
pertuzumabPhase 2Monoclonal Antibody1 trial
Active Trials
NCT01730833Active Not RecruitingEst. May 2026
BioInvent International
1 program
1
BI-1607Phase 1/21 trial
Active Trials
NCT05555251Terminated18Est. Feb 2024
Pfizer
PfizerNEW YORK, NY
1 program
1
Palbociclib 75mgPhase 1/21 trial
Active Trials
NCT03709082TerminatedEst. Feb 2021
Vaccinex
VaccinexROCHESTER, NY
1 program
1
Dendritic CellPhase 11 trial
Active Trials
NCT05378464RecruitingEst. Dec 2026
Orum Therapeutics
Orum TherapeuticsKorea - Daejeon
1 program
1
ORM-5029Phase 11 trial
Active Trials
NCT05511844Terminated25Est. Jun 2025
B
ByondisNetherlands - Nijmegen
1 program
1
Vic-trastuzumab duocarmazinePhase 11 trial
Active Trials
NCT04602117WithdrawnEst. Nov 2021
Genomics
GenomicsUK - Oxford
2 programs
Personalized treatment according to molecular diagnosis with HER2DXN/A1 trial
TrastuzumabN/AMonoclonal Antibody1 trial
Active Trials
NCT06446882Recruiting304Est. Nov 2028
NCT05912062Unknown80Est. Dec 2024
Affibody
AffibodySweden - Solna
1 program
ABY-PETN/A1 trial
Active Trials
NCT03655353Unknown160Est. Nov 2025
TerSera Therapeutics
TerSera TherapeuticsIL - Deerfield
1 program
MargetuximabN/AMonoclonal Antibody1 trial
Active Trials
NCT03133988Approved For Marketing

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
2030
2031
Chia Tai TianQing Pharmaceutical GroupTQB2102 for injection
Chia Tai TianQing Pharmaceutical GroupTQB2440 injection + Trastuzumab + Docetaxel
Jazz PharmaceuticalsZanidatamab
Daiichi SankyoTrastuzumab deruxtecan
RocheInavolisib
GenentechPertuzumab+TRASTUZUMAB
RocheTrastuzumab and pertuzumab Subcutaneous Fixed-Dose Combination
EisaiPertuzumab
City Therapeuticspertuzumab
BioInvent InternationalBI-1607
PfizerPalbociclib 75mg
Orum TherapeuticsORM-5029
VaccinexDendritic Cell
ByondisVic-trastuzumab duocarmazine
Daiichi SankyoNo drug

Showing 15 of 21 trials with date data

Clinical Trials (22)

Total enrollment: 3,515 patients across 22 trials

NCT07043725Chia Tai TianQing Pharmaceutical GroupTQB2102 for injection

A Clinical Study of Neoadjuvant Treatment With TQB2102 for Injection for Human Epidermal Growth Factor Receptor 2 (HER2) Positive Breast Cancer

Start: Sep 2025Est. completion: Sep 2029
Phase 3Recruiting
NCT05985187Chia Tai TianQing Pharmaceutical GroupTQB2440 injection + Trastuzumab + Docetaxel

Clinical Study to Evaluate the Efficacy and Safety of TQB2440 Injection/Perjeta® Combined With Trastuzumab and Docetaxel in the Treatment of Patients With Early or Locally Advanced Breast Cancer.

Start: Oct 2020Est. completion: Dec 2023
Phase 3Unknown
NCT07102381Jazz PharmaceuticalsZanidatamab

A Phase 2 Neoadjuvant Study of Zanidatamab in Combination With Chemotherapy in Participants With HER2-positive Breast Cancer

Start: Sep 2025Est. completion: Aug 2030125 patients
Phase 2Recruiting
NCT05982678Daiichi SankyoTrastuzumab deruxtecan

Basket Study for Oligo-metastatic Breast Cancer

Start: May 2024Est. completion: Oct 203472 patients
Phase 2Recruiting
NCT05306041RocheInavolisib

Neoadjuvant Endocrine Therapy +/- the PI3K Inhibitor Inavolisib in HER2+, HR+, PIK3CA Mutant Early Breast Cancer

Start: Jan 2023Est. completion: Jan 2027170 patients
Phase 2Recruiting
NCT04569747GenentechPertuzumab+TRASTUZUMAB

A Single Arm Phase II Study of ADjuvant Endocrine Therapy, Pertuzumab, and Trastuzumab for Patients With Anatomic Stage I Hormone Receptor-positive, HER2-positive Breast Cancer

Start: Jan 2021Est. completion: Sep 2030375 patients
Phase 2Recruiting
NCT04578106RocheTrastuzumab and pertuzumab Subcutaneous Fixed-Dose Combination

Omission of Surgery in Clinically Low-risk HER2positive Breast Cancer With High HER2 Addiction and a Complete Response Following Standard Anti-HER2-based Neoadjuvant Therapy

Start: Sep 2020Est. completion: Jul 20245 patients
Phase 2Terminated
NCT01912963EisaiPertuzumab

Phase II Study of Eribulin Mesylate, Trastuzumab, and Pertuzumab in Women With Metastatic, Unresectable Locally Advanced, or Locally Recurrent HER2-Positive Breast Cancer

Start: Sep 2013Est. completion: Dec 201632 patients
Phase 2Terminated
NCT01730833City Therapeuticspertuzumab

Pertuzumab, Trastuzumab, and Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With HER2-Positive Advanced Breast Cancer

Start: Jul 2013Est. completion: May 2026
Phase 2Active Not Recruiting
NCT05555251BioInvent InternationalBI-1607

BI-1607 in Combination with Trastuzumab in Subjects with HER2-positive Advanced Solid Tumors

Start: Jul 2022Est. completion: Feb 202418 patients
Phase 1/2Terminated
NCT03709082PfizerPalbociclib 75mg

Palbociclib in Estrogen Receptor Positive (ER+) Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Metastatic Breast Cancer

Start: Oct 2018Est. completion: Feb 2021
Phase 1/2Terminated
NCT05511844Orum TherapeuticsORM-5029

Study of ORM-5029 in Subjects With HER2-Expressing Advanced Solid Tumors

Start: Oct 2022Est. completion: Jun 202525 patients
Phase 1Terminated
NCT05378464VaccinexDendritic Cell

Adoptive T Cell Therapy Following HER2-Pulsed Dendritic Cell Vaccine & Pepinemab /Trastuzumab in Patients w/ Metastatic HER2+ Breast Cancer

Start: May 2022Est. completion: Dec 2026
Phase 1Recruiting
NCT04602117ByondisVic-trastuzumab duocarmazine

ISPY-P1.01:Evaluating the Safety of Weekly Paclitaxel With Trastuzumab Duocarmazine (SYD985) in Patients With Metastatic Cancer

Start: Jul 2021Est. completion: Nov 2021
Phase 1Withdrawn
NCT03133988TerSera TherapeuticsMargetuximab

Margetuximab Expanded Access Program

N/AApproved For Marketing
NCT06833268Daiichi SankyoNo drug

Real-world Outcomes of Patients With HER2+ Metastatic Breast Cancer After Treatment With Trastuzumab Deruxtecan

Start: Jan 2025Est. completion: Jun 2025228 patients
N/ACompleted
NCT06446882GenomicsPersonalized treatment according to molecular diagnosis with HER2DX

Diagnostic HER2DX-guided Treatment for Patients wIth Early-stage HER2-positive Breast Cancer

Start: Oct 2024Est. completion: Nov 2028304 patients
N/ARecruiting
NCT06210776Daiichi SankyoTrastuzumab deruxtecan

A Study to Assess the Effectiveness of Trastuzumab Deruxtecan in Chinese Breast Cancer Patients (REFRESH)

Start: Jan 2024Est. completion: Mar 2028800 patients
N/ARecruiting
NCT05769751Daiichi SankyoElectronic medical record and hospital information system or other available resources

A Study to Describe the Real-world Treatment Patterns and Associated Outcomes in Patients of China With HER2-positive Unresectable or Metastatic Breast Cancer

Start: Mar 2023Est. completion: Jul 2023865 patients
N/ACompleted
NCT05458401Daiichi SankyoTrastuzumab deruxtecan

EUropean Real-world Experience Of Previously Treated Advanced/Metastatic HER2-positive Breast Cancer Patients Accessing Trastuzumab Deruxtecan

Start: Nov 2022Est. completion: Dec 2023256 patients
N/ACompleted
NCT05912062GenomicsTrastuzumab

Early On-treatment Transcriptional Profiling as Predictor of Response in Early-stage HER2-positive Breast Cancer

Start: Mar 2021Est. completion: Dec 202480 patients
N/AUnknown
NCT03655353AffibodyABY-PET

A Study of 68Ga-ABY-025 PET for Non-invasive Quantification of HER2-expression in Advanced Breast Cancer

Start: Aug 2018Est. completion: Nov 2025160 patients
N/AUnknown

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Phase Legend

Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available

Key Insights

2 late-stage (Phase 3) programs — potential near-term approvals
8 actively recruiting trials targeting 3,515 patients
16 companies competing in this space

Related Indications

Breast Cancer(530)Non-small Cell Lung Cancer(373)Prostate Cancer(371)Multiple Myeloma(244)Advanced Solid Tumors(221)Acute Myeloid Leukemia(204)Cancer(187)Neoplasms(173)Colorectal Cancer(166)Advanced Solid Tumor(165)