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Breast Cancer

Oncology 17 original drugs
17
Novel Drugs
19
Reformulations
1,588
Active Trials
33
Drug Targets

Oncology indication. Breast Cancer has 17 FDA-approved novel treatments, led by Roche, with 1588 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.

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Q4 2026
D-0502
InventisBio Co., Ltd
Estimated · aging NCT06954961
Q4 2026
SPH4336 Tablets
Shanghai Pharmaceuticals Holding Co., Ltd
Estimated · aging NCT05860465
Q4 2026
KN026
Shanghai JMT-Bio Inc.
Estimated · stale NCT06747338
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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 120 industry trials with a known mechanism of action.

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Kinase Inhibitor
47 trials 20 active 12 sponsors
PIK3CA
10 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
Programmed Death Receptor-1 Blocking Antibody
9 trials 1 active 3 sponsors
Microtubule Inhibitor
9 trials 1 active 8 sponsors
Aromatase Inhibitor
7 trials 1 active 5 sponsors
Nucleoside Metabolic Inhibitor
7 trials 1 active 4 sponsors
Endoglycosidase
5 trials 1 active 3 sponsors
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

1357 industry-sponsored trials across 500 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 (9 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