Breast Cancer
Breast Cancer arises from malignant transformation of breast tissue and includes multiple molecular subtypes. Biomarker-defined subsets guide targeted therapy decisions.
Biomarkers used in this indication
Each approval combines this indication with specific biomarker criteria and a therapy. Select a therapy from the tables below to open its FDA-defined testing pathway.
Defined explicitly for Breast Cancer in FDA labeling.
| Biomarker | Biomarker criteria | Therapies |
|---|---|---|
| BRCA1 and BRCA2 |
| |
| ERBB2 (HER2) |
| |
| ERBB2 (HER2) |
| |
| ERBB2 (HER2) |
| |
| ERBB2 (HER2) |
| |
| ESR1 |
| |
| PIK3CA |
| |
| PIK3CA |
| |
| PIK3CA |
|
Defined at the solid tumor level and applicable to Breast Cancer and other solid tumor cancers.
Therapies with biomarker-defined approvals
Each therapy below has at least one FDA companion diagnostic approval tied to Breast Cancer. Select a therapy to view the specific approval and eligible tests.
ERBB2 (HER2) (HER2 ultralow expression (IHC 0 with membrane staining)); ERBB2 (HER2) (HER2-low expression (IHC 1+ or IHC 2+/ISH non-amplified))
ERBB2 (HER2) (gene amplification); ERBB2 (HER2) (HER-2 protein overexpression)
PIK3CA (alterations (including mutations))
deficient mismatch repair (dMMR) proteins (MLH1, PMS2, MSH2 and MSH6); MSI-High (Microsatellite instability-High)
ERBB2 (HER2) (gene amplification); ERBB2 (HER2) (HER-2 protein overexpression)
deficient mismatch repair (dMMR) proteins (MLH1, PMS2, MSH2 and MSH6); MSI-High (Microsatellite instability-High); TMB (TMB ≥ 10 mutations per megabase)
BRCA1 and BRCA2 (alterations (including mutations))
ESR1 (ESR1 missense mutations between codons 310 and 547)
ERBB2 (HER2) (gene amplification); ERBB2 (HER2) (HER-2 protein overexpression)
PIK3CA (C420R, E542K, E545A, E545D [1635G>T only], E545G, E545K, Q546E, Q546R, H1047L, H1047R, and H1047Y)
RET (fusions)
NTRK1, NTRK2 and NTRK3 (fusions)
BRCA1 and BRCA2 (alterations (including mutations))
PIK3CA (AKT1/PTEN alterations)
NTRK1, NTRK2 and NTRK3 (fusions)