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Breast Cancer

Oncology 17 original drugs
17
Novel Drugs
19
Reformulations
1,516
Active Trials
33
Drug Targets

Oncology indication. Breast Cancer has 17 FDA-approved novel treatments, led by Roche, with 1516 active industry clinical trials across 33 drug targets. Explore market leaders, treatments by mechanism, the clinical pipeline, and drug targets below.

Breast Cancer Market Leaders

Companies with the most FDA-approved novel Breast Cancer drugs.

Phase 3 Readouts Pro

12 active Phase 3 trials with confidence-graded completion dates.

Full calendar →
Q3 2026
AZD9833
AstraZeneca
Estimated · aging NCT04711252
Q4 2026
JSKN003
Shanghai JMT-Bio Inc.
Estimated · stale NCT06846437
Q4 2026
Afuresertib
Laekna Limited
Estimated · fresh NCT04851613
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Anchored on CT.gov primary completion date. Topline announcements typically precede this by 3–9 months. Confidence labels combine date type (ACTUAL/ESTIMATED) with last-update freshness.

Breast Cancer Treatments by Mechanism

Top 12 mechanisms across 126 industry trials with a known mechanism of action.

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Kinase Inhibitor
46 trials 20 active 12 sponsors
PIK3CA
9 trials 4 active 2 sponsors
Trop-2
5 trials 4 active 1 sponsor
Estrogen Receptor Antagonist
11 trials 2 active 5 sponsors
Poly(ADP-Ribose) Polymerase Inhibitor
6 trials 2 active 1 sponsor
AKT1/AKT2/AKT3
3 trials 2 active 1 sponsor
Microtubule Inhibitor
17 trials 1 active 9 sponsors
Programmed Death Receptor-1 Blocking Antibody
13 trials 1 active 5 sponsors
Aromatase Inhibitor
7 trials 1 active 5 sponsors
Nucleoside Metabolic Inhibitor
7 trials 1 active 4 sponsors
Endoglycosidase
1 trials 1 active 1 sponsor
Hypoxia-inducible Factor Inhibitor
1 trials 1 active 1 sponsor

MoA derived from FDA pharmClassEpc when intervention matches an approved drug. Codenamed clinical-stage assets without an approved counterpart show "—" and aren't grouped here — they're still in the phase tables below.

Breast Cancer Clinical Pipeline by Phase

1313 industry-sponsored trials across 484 sponsors

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Precision Medicine Biomarkers

All biomarkers →

Biomarkers used for patient selection in Breast Cancer

Reformulations (19 drugs) Click to expand

Breast Cancer Drug Targets

Molecular targets of approved and investigational Breast Cancer drugs — 33 targets tracked.

Biosimilars (13 BLA approved) Click to expand
Generic Drugs (12 ANDA approved) Click to expand

Related Indications

Other Oncology indications

Drug Categories:

  • Novel Drugs: NDA Type 1/2 (new molecular entity) or original BLA
  • Reformulations: NDA Type 3/5 (new dosage form of existing molecule)
  • Biosimilars: BLA-approved biologics highly similar to reference products
  • Generics: ANDA-approved copies of small molecule drugs

View data sources and methodology