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HER2-positive Breast Cancer

Oncology
22
Pipeline Programs
30
Companies
40
Clinical Trials
12 recruiting
1
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
7
2
5
3
4
1
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Monoclonal Antibody
953%
Small Molecule
424%
ADC
318%
Vaccine
16%
+ 30 programs with unclassified modality

Oncology is a $53.9B market in consolidation, dominated by a handful of megacap players with blockbuster franchises approaching patent expiration.

$53.9B marketConsolidating→ Stable30 products15 companies

Key Trends

  • Heavy patent cliff exposure (REVLIMID $3.9B LOE 2028, JAKAFI $1.9B LOE 2028)
  • Kinase inhibitors and immunomodulatory agents dominate spend; limited diversification in top 10
  • Clinical trial volume remains exceptionally high (29,145 trials) but concentration in Phase 1-2 signals early-stage pipeline challenges

Career Verdict

Strong near-term opportunity for R&D and medical affairs roles, but competitive landscape and patent cliff urgency favor specialists over generalists.

AI-generated market analysis based on FDA, CMS, ClinicalTrials.gov, and hiring data

Market Leaders

#1ELIQUISStable
$18.3B
Bristol Myers Squibb·Launch15.0yr
#2FARXIGAStable
$4.3B
AstraZeneca·Peak15.4yr
#3REVLIMIDDeclining
$3.9B
Bristol Myers Squibb·LOE Approaching1.8yr
#4XTANDIStable
$2.6B
Astellas·Peak10.7yr
#5IMBRUVICAStable
$2.4B
AbbVie·Peak8.9yr

Drug Class Breakdown

FXa Inhibitors
$18.3B(34%)

concentrated in single product

SGLT2 Inhibitors
$4.3B(8%)

single dominant product

Kinase Inhibitors
$4.0B(7%)

multi-product class, competitive

Immunomodulatory Agents (Cereblon)
$3.9B(7%)

facing near-term patent cliff

Androgen Receptor Antagonists
$2.6B(5%)

prostate cancer specialty

Protein Kinase Inhibitors
$2.4B(4%)

niche hematologic oncology

JAK Inhibitors
$1.9B(4%)

near-term LOE exposure

Career Outlook

Stable

Oncology remains a premium therapeutic area but faces structural headwinds: top 10 products account for >80% of spend, patent cliffs loom (REVLIMID 2028), and late-stage pipeline thinness suggests slower near-term growth. However, high trial volume and consolidation create demand for specialized expertise in regulatory, clinical operations, and lifecycle management. Pharma professionals with kinase inhibitor, immunomodulatory, or ADC experience are in highest demand.

Breaking In

Entry-level candidates should target CROs (Thermo Fisher, IQVIA), emerging biotech (BeiGene, BeOne), or contract manufacturing; oncology specialization requires demonstrated domain knowledge.

For Experienced Professionals

Experienced professionals should focus on lifecycle/patent strategy roles (high salary, low headcount) or pivot to emerging modalities (ADCs, bispecifics) to avoid commoditization in crowded kinase inhibitor space.

In-Demand Skills

Regulatory strategy & PDUFA navigationKinase inhibitor development (small molecule)Clinical trial operations & site managementLifecycle management & patent strategyMedical affairs (oncology-specific science)Manufacturing scale-up (small molecule & biotech)

Best For

Regulatory Affairs ManagerClinical Operations ManagerMedical Science Liaison (MSL) — OncologyLifecycle ManagerR&D Scientist (medicinal chemistry, ADME)Manufacturing Engineer

Hiring Landscape

$102K–$266K

Oncology hiring is actively concentrated at Thermo Fisher Scientific (CRO/CDMO services, 559 jobs), AstraZeneca (208 jobs), and emerging biotech players like BeiGene (185 jobs). Commercial roles dominate (412 jobs, $136K avg) but R&D positions offer the highest salary premium ($199K avg, 347 roles). Patent cliff urgency is creating acute demand for regulatory, CMC, and lifecycle management expertise.

1,946
Open Roles
5
Companies Hiring
5
Departments

Top Hiring Companies

208Stable
185Growing
167Growing
147Growing

By Department

Commercial(21%)
$136K
Research & Development(18%)
$199K
Clinical Operations(5%)
$181K
Medical Affairs(4%)
$266K
Manufacturing(5%)
$102K

Strong near-term hiring momentum, especially in CRO/CDMO and emerging biotech; Medical Affairs offers highest compensation but limited headcount.

On Market (1)

Approved therapies currently available

Roche
HERCEPTINApproved
trastuzumab
Roche
HER2/neu Receptor Antagonist [EPC]intravenous1998
4M Part D

Competitive Landscape

32 companies ranked by most advanced pipeline stage

Roche
RocheSTAVANGER NORWAY, Norway
2 programs
1
InavolisibPHASE_2Small Molecule1 trial
Trastuzumab and pertuzumab Subcutaneous Fixed-Dose CombinationPHASE_21 trial
Active Trials
NCT05306041Recruiting170Est. Jan 2027
NCT04578106Terminated5Est. Jul 2024
Biocorp
BiocorpFrance - Issoire
4 programs
1
1
2
BL-M07D1Phase 31 trial
BL-M07D1Phase 31 trial
BL-M07D1Phase 2/31 trial
BL-M07D1Phase 21 trial
Active Trials
NCT06445400Recruiting120Est. Jun 2026
NCT06891833Recruiting120Est. Dec 2028
NCT06830889Recruiting1,450Est. Dec 2031
+1 more trials
BioNTech
BioNTechCA - San Diego
1 program
1
DB-1303/BNT323Phase 31 trial
Active Trials
NCT06265428Active Not Recruiting228Est. Feb 2026
Cinnagen
1 program
1
TrastuzumabPhase 3Monoclonal Antibody1 trial
Active Trials
NCT04957212Completed214Est. May 2020
UNION therapeutics
1
lapatinib/herceptinPhase 2/3
PyrotinibN/ASmall Molecule1 trial
pyrotinib combined with CapecitabineN/A1 trial
Active Trials
NCT06754059Recruiting60Est. Dec 2027
NCT06035016Recruiting300Est. Jun 2027
EOC Pharma
EOC PharmaCA - Westlake Village
1 program
1
lapatinib/herceptinPhase 2/31 trial
Active Trials
NCT03085368Unknown482Est. Mar 2021
Puma Biotechnology
Puma BiotechnologyLOS ANGELES, CA
1 program
1
NeratinibPhase 2Small Molecule1 trial
Active Trials
NCT03094052Completed11Est. Oct 2022
MSD
MSDIreland - Ballydine
1 program
1
PaclitaxelPhase 21 trial
Active Trials
NCT03747120Active Not Recruiting138Est. Dec 2029
Sharp Therapeutics
Sharp TherapeuticsPA - Pittsburgh
1 program
1
PaclitaxelPhase 2
Biocon
BioconIndia - Bangalore
1 program
1
Tucatinib 150 MGPhase 2
Klus Pharma
Klus PharmaNJ - Princeton
1 program
1
A166Phase 1/21 trial
Active Trials
NCT03602079Completed49Est. Jan 2022
Genor Biopharma
Genor BiopharmaChina - Shanghai
1 program
1
GB221,2 mg/kgPhase 1/21 trial
Active Trials
NCT04170595Unknown132Est. Dec 2022
Alteogen
2 programs
2
ALT-P7Phase 11 trial
HM2-MMAE conjugatePhase 1
Active Trials
NCT03281824Completed27Est. Jan 2021
Enliven Therapeutics
1 program
1
ELVN-002Phase 11 trial
Active Trials
NCT06328738Active Not Recruiting275Est. Jul 2028
GeneQuantum
GeneQuantumChina - Suzhou
1 program
1
GQ1001Phase 11 trial
Active Trials
NCT04450732Unknown96Est. May 2024
Marker Therapeutics
1 program
1
HER-2/neu peptide vaccinePhase 1Vaccine1 trial
Active Trials
NCT01632332Completed22Est. Jul 2018
Sandoz
SandozAustria - Kundl
1 program
1
PI3K inhibitor BYL719Phase 11 trial
Active Trials
NCT02038010Completed17Est. May 2017
Nielsen BioSciences
Nielsen BioSciencesCA - San Diego
1 program
1
Radiolabeled [68Ga]ABY-025Phase 11 trial
Active Trials
NCT02095210Terminated2Est. Aug 2014
Daiichi Sankyo
Daiichi SankyoChina - Shanghai
5 programs
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
Trastuzumab deruxtecanPHASE_2ADC1 trial
Active Trials
NCT05769751Completed865Est. Jul 2023
NCT06833268Completed228Est. Jun 2025
NCT05458401Completed256Est. Dec 2023
+2 more trials
Genomics
GenomicsUK - Oxford
2 programs
Personalized treatment according to molecular diagnosis with HER2DXN/A
TrastuzumabN/AMonoclonal Antibody
Reveal Pharmaceuticals
2 programs
Personalized treatment according to molecular diagnosis with HER2DXN/A1 trial
TrastuzumabN/AMonoclonal Antibody1 trial
Active Trials
NCT06446882Recruiting304Est. Nov 2028
NCT05912062Unknown80Est. Dec 2024
Genentech
GenentechCA - Oceanside
2 programs
PertuzumabPHASE_2Monoclonal Antibody
Pertuzumab+TRASTUZUMABPHASE_2Monoclonal Antibody1 trial
Active Trials
NCT04569747Active Not Recruiting393Est. Sep 2030
Chia Tai TianQing Pharmaceutical Group
2 programs
TQB2102 for injectionPHASE_31 trial
TQB2440 injection + Trastuzumab + DocetaxelPHASE_31 trial
Active Trials
NCT07043725Recruiting544Est. Sep 2029
NCT05985187Unknown412Est. Dec 2023
TerSera Therapeutics
TerSera TherapeuticsIL - Deerfield
1 program
MargetuximabN/AMonoclonal Antibody1 trial
Active Trials
NCT03133988Approved For Marketing
Parexel
ParexelMA - Boston
1 program
TucatinibN/ASmall Molecule1 trial
Active Trials
NCT04220203Approved For Marketing
Vaccinex
VaccinexROCHESTER, NY
1 program
Dendritic CellPHASE_11 trial
Active Trials
NCT05378464Recruiting28Est. Dec 2026
Orum Therapeutics
Orum TherapeuticsKorea - Daejeon
1 program
ORM-5029PHASE_11 trial
Active Trials
NCT05511844Terminated25Est. Jun 2025
Byondis
ByondisNetherlands - Nijmegen
1 program
Vic-trastuzumab duocarmazinePHASE_11 trial
Active Trials
NCT04602117Withdrawn0Est. Nov 2021
BioInvent International
1 program
BI-1607PHASE_1_21 trial
Active Trials
NCT05555251Terminated18Est. Feb 2024
Eisai
EisaiChina - Liaoning
1 program
PertuzumabPHASE_2Monoclonal Antibody1 trial
Active Trials
NCT01912963Terminated32Est. Dec 2016

+2 more companies

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
BiocorpBL-M07D1
BiocorpBL-M07D1
BioNTechDB-1303/BNT323
Chia Tai TianQing Pharmaceutical GroupTQB2440 injection + Trastuzumab + Docetaxel
CinnagenTrastuzumab
BiocorpBL-M07D1
EOC Pharmalapatinib/herceptin
Jazz PharmaceuticalsZanidatamab
BiocorpBL-M07D1
Daiichi SankyoTrastuzumab deruxtecan
RocheInavolisib
GenentechPertuzumab+TRASTUZUMAB
RocheTrastuzumab and pertuzumab Subcutaneous Fixed-Dose Combination
MSDPaclitaxel

Showing 15 of 38 trials with date data

Clinical Trials (40)

Total enrollment: 8,374 patients across 40 trials

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 2029544 patients
Phase 3Recruiting

A Study of BL-M07D1 Versus T-DM1 in the Adjuvant Treatment of HER2-positive Breast Cancer With Residual Invasive Cancer After Neoadjuvant Therapy

Start: Jun 2025Est. completion: Dec 20311,450 patients
Phase 3Recruiting

A Study Comparing BL-M07D1 With T-DM1 in Patients With Unresectable Locally Advanced or Metastatic HER2-positive Breast Cancer

Start: May 2024Est. completion: May 2026274 patients
Phase 3Active Not Recruiting
NCT06265428BioNTechDB-1303/BNT323

A Study to Compare DB-1303/BNT323 Versus T-DM1 in Breast Cancer

Start: Jan 2024Est. completion: Feb 2026228 patients
Phase 3Active Not Recruiting
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 2023412 patients
Phase 3Unknown

Comparing Efficacy and Safety Between Pertuzumab® and Perjeta® in Neoadjuvant Treatment of HER2+ Breast Cancer

Start: Aug 2018Est. completion: May 2020214 patients
Phase 3Completed

A Study of BL-M07D1 With or Without Pertuzumab Versus Taxane + Trastuzumab and Pertuzumab in Neoadjuvant Therapy for HER2-Positive Breast Cancer

Start: Jun 2025Est. completion: Dec 2028120 patients
Phase 2/3Recruiting
NCT03085368EOC Pharmalapatinib/herceptin

A Randomized Controlled Trial of HER-2 Positive Breast Cancer Patients Treated With Lapatinib vs Herceptin

Start: Mar 2017Est. completion: Mar 2021482 patients
Phase 2/3Unknown

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

A Study of BL-M07D1, BL-M07D1+Pertuzumab and BL-M07D1+Pertuzumab+Docetaxel in Patients With Unresectable Locally Advanced or Metastatic HER2-positive Breast Cancer

Start: Jun 2024Est. completion: Jun 2026120 patients
Phase 2Recruiting
NCT05982678Daiichi SankyoTrastuzumab deruxtecan

Basket Study for Oligo-metastatic Breast Cancer

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

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 2030393 patients
Phase 2Active Not Recruiting
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
NCT03747120MSDPaclitaxel

Neoadjuvant Her2-targeted Therapy and Immunotherapy With Pembrolizumab [IIT2018-04-MCARTHUR-NEOHP]

Start: Jan 2019Est. completion: Dec 2029138 patients
Phase 2Active Not Recruiting

Incidence and Severity of Diarrhea in Patients With HER2 Positive Breast Cancer Treated With Trastuzumab and Neratinib

Start: Oct 2018Est. completion: Oct 202211 patients
Phase 2Completed

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

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

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

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

Study of A166 in Patients With Relapsed/Refractory Cancers Expressing HER2 Antigen or Having Amplified HER2 Gene

Start: Jul 2018Est. completion: Jan 202249 patients
Phase 1/2Completed

Clinical Study of Recombinant Anti-HER2 Humanized Monoclonal Antibody for Injection

Start: Mar 2014Est. completion: Dec 2022132 patients
Phase 1/2Unknown

ELVN-002 With Trastuzumab +/- Chemotherapy in HER2+ Solid Tumors, Colorectal and Breast Cancer

Start: May 2024Est. completion: Jul 2028275 patients
Phase 1Active Not Recruiting

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 202628 patients
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 20210
Phase 1Withdrawn

Safety of GQ1001 in Adult Patients With HER2-Positive Advanced Solid Tumors

Start: Jul 2020Est. completion: May 202496 patients
Phase 1Unknown

Clinical Study of ALT-P7 to Determine Safety, Tolerability and Pharmacokinetics in Breast Cancer Patients

Start: Jan 2018Est. completion: Jan 202127 patients
Phase 1Completed
NCT02038010SandozPI3K inhibitor BYL719

BYL719 + T-DM1 in HER2(+) Metastatic Breast Cancer Pts Who Progress on Prior Trastuzumab & Taxane Tx

Start: May 2014Est. completion: May 201717 patients
Phase 1Completed
NCT01632332Marker TherapeuticsHER-2/neu peptide vaccine

Vaccine Therapy in Treating Patients With Previously Treated Stage II-III HER2-Positive Breast Cancer

Start: Jul 2012Est. completion: Jul 201822 patients
Phase 1Completed
NCT02095210Nielsen BioSciencesRadiolabeled [68Ga]ABY-025

HER2 PET Imaging in Breast Cancer Patients Using [68GA]ABY-025

Start: Aug 2011Est. completion: Aug 20142 patients
Phase 1Terminated

Treatment Protocol of Tucatinib With Capecitabine and Trastuzumab in Patients With Unresectable Previously Treated HER2+ Breast Cancer

N/AApproved For Marketing

Margetuximab Expanded Access Program

N/AApproved For Marketing

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

Start: Jan 2025Est. completion: Jun 2025228 patients
N/ACompleted
NCT06446882Reveal PharmaceuticalsPersonalized 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
NCT06035016UNION therapeuticspyrotinib combined with Capecitabine

Pyrotinib Plus Capecitabine for Adjuvant Treatment of HER2 Positive Early-stage Breast Cancer

Start: Jun 2023Est. completion: Jun 2027300 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

Pyrotinib Combined With Trastuzumab for Maintenance Therapy After First-line TH (P) Therapy for HER2+ABC

Start: Jun 2021Est. completion: Dec 202760 patients
N/ARecruiting

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

Related Jobs in Oncology

Phase Legend

PreclinicalLab & animal studies
Phase 1Safety & dosing
Phase 2Efficacy testing
Phase 3Large-scale trials
On MarketApproved & available

Key Insights

4 late-stage (Phase 3) programs, potential near-term approvals
12 actively recruiting trials targeting 8,374 patients
30 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.