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HER2+ Metastatic Breast Cancer

Oncology
3
Pipeline Programs
2
Companies
28
Clinical Trials
7 recruiting
1
Approved Products

Pipeline by Development Stage

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

Drug Modality Breakdown

Small Molecule
150%
Monoclonal Antibody
150%

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

Pfizer
TUKYSAApproved
tucatinib
Pfizer
Kinase Inhibitor [EPC]oral2020
102M Part D

Competitive Landscape

2 companies ranked by most advanced pipeline stage

Pfizer
PfizerNEW YORK, NY
1 program
1
TUKYSA(tucatinib)APPROVED_FOR_MARKETINGSmall Molecule5 trials
Active Trials
NCT03424473No Longer Available
NCT06983691Not Yet Recruiting26Est. Dec 2026
NCT07193394Recruiting20Est. Jun 2029
+2 more trials
Sandoz
SandozAustria - Kundl
1 program
1
Asciminib and TrastuzumabPhase 1/2Monoclonal Antibody1 trial
Active Trials
NCT07136428Not Yet Recruiting42Est. Nov 2032

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
2030
2031
Pfizertucatinib
Pfizertucatinib
Pfizertucatinib
Pfizertucatinib
Pfizertucatinib
Pfizertucatinib
Pfizertucatinib
Pfizertucatinib
Pfizertucatinib
Pfizertucatinib
Pfizertucatinib
Pfizertucatinib
Pfizertucatinib
Pfizertucatinib
Pfizertucatinib

Showing 15 of 27 trials with date data

Clinical Trials (28)

Total enrollment: 1,646 patients across 28 trials

A Study of Tucatinib With Trastuzumab and mFOLFOX6 Versus Standard of Care Treatment in First-line HER2+ Metastatic Colorectal Cancer

Start: Oct 2022Est. completion: Jul 2029400 patients
Phase 3Recruiting

Tucatinib and Trastuzumab in HER3-mutant and HER2-not Amplified Metastatic Breast Cancer

Start: Jan 2026Est. completion: Jun 202920 patients
Phase 2Recruiting

Tucatinib in Combination With Oral Etoposide andTrastuzumab in Patients With Metastatic HER2+ Breast Cancer

Start: Dec 2023Est. completion: Dec 202866 patients
Phase 2Recruiting

Capecitabine, Tucatinib, and Intrathecal Trastuzumab for Breast Cancer Patients With Leptomeningeal Disease

Start: Dec 2023Est. completion: Jun 202730 patients
Phase 2Recruiting

Tucatinib, Trastuzumab and Capecitabine With Brain and/or Spinal Radiotherapy (XRT) in Patients With HER2+, HER2 Mutated and/or HER2-amplified Metastatic Breast Cancer and Leptomeningeal Disease: A Multi-centre Phase II, Single Arm Feasibility Study

Start: Nov 2023Est. completion: Oct 202830 patients
Phase 2Recruiting

Study of Tucatinib and Doxil in Participants With Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Metastatic Breast Cancer

Start: Jul 2023Est. completion: Nov 202736 patients
Phase 2Recruiting

A Study of Tucatinib Given Before Surgery to People With HER2+ Cancers That Have Spread to the Brain

Start: May 2023Est. completion: May 20289 patients
Phase 2Active Not Recruiting

Secondary BRain Metastases Prevention After Isolated Intracranial Progression on Trastuzumab/Pertuzumab or T-DM1 in Patients With aDvanced Human Epidermal Growth Factor Receptor 2+ brEast Cancer With the Addition of Tucatinib

Start: Mar 2023Est. completion: Jul 202648 patients
Phase 2Active Not Recruiting

Efficacy and Safety of the Combination of Trastuzumab Plus TUCAtinib Plus viNorelbine in Patients With HER2-positive Non-resectable Locally Advanced or Metastatic Breast Cancer

Start: Mar 2023Est. completion: May 202513 patients
Phase 2Terminated

Treatment With Tucatinib in Patients With an Isolated Brain Progression of a Metastatic Breast Cancer

Start: Dec 2021Est. completion: Apr 202653 patients
Phase 2Active Not Recruiting

A Study of Tucatinib (MK-7119) in Combination With Trastuzumab and Capecitabine in Participants With Previously Treated Locally Advanced Unresectable or Metastatic Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Breast Carcinoma (MK-7119-001)

Start: Apr 2021Est. completion: Jun 202666 patients
Phase 2Active Not Recruiting

Basket Study of Tucatinib and Trastuzumab in Solid Tumors With HER2 Alterations

Start: Jan 2021Est. completion: Apr 2026217 patients
Phase 2Active Not Recruiting

A Study of Tucatinib Plus Trastuzumab Deruxtecan in HER2+ Breast Cancer

Start: Dec 2020Est. completion: Mar 202570 patients
Phase 2Completed

Tucatinib Plus Trastuzumab and Oxaliplatin-based Chemotherapy or Pembrolizumab-containing Combinations for HER2+ Gastrointestinal Cancers

Start: Sep 2020Est. completion: Dec 202640 patients
Phase 2Active Not Recruiting

Tucatinib, Trastuzumab, and Capecitabine for the Treatment of HER2+ LMD

Start: Feb 2019Est. completion: Jun 202117 patients
Phase 2Terminated

Tucatinib Plus Trastuzumab in Patients With HER2+ Colorectal Cancer

Start: Jun 2017Est. completion: Nov 2023117 patients
Phase 2Completed
NCT07136428SandozAsciminib and Trastuzumab

Asciminib in HER2+ Breast Cancer Brain Metastases

Start: Feb 2026Est. completion: Nov 203242 patients
Phase 1/2Not Yet Recruiting

Tucatinib, Trastuzumab, and Capecitabine With SRS for Brain Metastases From HER-2 Positive Breast Cancer

Start: Jan 2024Est. completion: Dec 20251 patients
Phase 1Terminated

Neoadjuvant Trastuzumab, Pertuzumab and Tucatinib Without Chemotherapy in HER2-positive Breast Cancer: the TRAIN-4 Study

Start: Dec 2023Est. completion: May 203630 patients
Phase 1Recruiting

A Drug-Drug Interaction Study in Healthy Volunteers of the Effects of Tucatinib on Metformin

Start: Feb 2019Est. completion: Mar 201918 patients
Phase 1Completed

A Safety Study of Tucatinib in Healthy and Hepatically-Impaired Subjects

Start: Oct 2018Est. completion: May 201937 patients
Phase 1Completed

A Study of the Absorption, Metabolism, and Excretion of Tucatinib in Healthy Participants

Start: Dec 2017Est. completion: Jan 20188 patients
Phase 1Completed

A Study of Tucatinib (ONT-380) Combined With Ado-trastuzumab Emtansine (T-DM1) in Patients With HER2+ Breast Cancer

Start: Feb 2014Est. completion: Sep 202057 patients
Phase 1Completed

A Study of Tucatinib (ONT-380) Combined With Capecitabine and/or Trastuzumab in Patients With HER2+ Metastatic Breast Cancer

Start: Dec 2013Est. completion: Mar 202060 patients
Phase 1Completed

Expanded Access Use of Tucatinib for HER2+ Metastatic Breast Cancer

N/ANo Longer Available

Patient Navigation for HER2+ Metastatic Breast Cancer Patients Treated With Tucatinib

Start: Apr 2026Est. completion: Dec 202626 patients
N/ANot Yet Recruiting

Real World-clinical Outcomes of Tucatinib, Trastuzumab, and Capecitabine Following Trastuzumab Deruxtecan (T-DXd) for the Treatment of HER2-positive Metastatic Breast Cancer.

Start: May 2025Est. completion: Sep 202586 patients
N/ACompleted

Tucatinib in Patients With Locally Advanced or Metastatic HER2-positive Breast Cancer Who Received at Least Two Prior Anti-HER2 Treatment Regimens.

Start: May 2022Est. completion: Jun 202549 patients
N/ACompleted

Related Jobs in Oncology

Phase Legend

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

Key Insights

7 actively recruiting trials targeting 1,646 patients
Small Molecule is the dominant modality (50% of programs)
2 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.