Last reviewed 2026-06-10 · How we verify

Breast cancer with a PIK3CA mutation, hormone receptor-positive, HER2-negative, ESR1 mutation, TP53 mutation, CDK4/6 inhibitor resistance, prior endocrine therapy, prior chemotherapy, prior radiotherapy, prior surgery, prior hormone therapy, and/or prior targeted therapy — Treatment Landscape & Competitive Intelligence

Breast cancer with a PIK3CA mutation, hormone receptor-positive, HER2-negative, ESR1 mutation, TP53 mutation, CDK4/6 inhibitor resistance, prior endocrine therapy, prior chemotherapy, prior radiotherapy, prior surgery, prior hormone therapy, and/or prior targeted therapy (disease) competitive landscape: 1 marketed trea

Marketed treatment landscape

Approved drugs treating Breast cancer with a PIK3CA mutation, hormone receptor-positive, HER2-negative, ESR1 mutation, TP53 mutation, CDK4/6 inhibitor resistance, prior endocrine therapy, prior chemotherapy, prior radiotherapy, prior surgery, prior hormone therapy, and/or prior targeted therapy, deduplicated by molecule. See the full disease page for line-of-therapy detail.

Phase 3 pipeline

No Phase 3 pipeline candidates tracked.

Phase 2 pipeline

No Phase 2 pipeline candidates tracked.

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this treatment set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this treatment set.

Sponsor landscape

1. Pfizer · 1 drug in Breast cancer with a PIK3CA mutation, hormone receptor-positive, HER2-negative, ESR1 mutation, TP53 mutation, CDK4/6 inhibitor resistance, prior endocrine therapy, prior chemotherapy, prior radiotherapy, prior surgery, prior hormone therapy, and/or prior targeted therapy

Subscribe to ongoing alerts

Every new regulatory action, PDUFA date, or trial completion in Breast cancer with a PIK3CA mutation, hormone receptor-positive, HER2-negative, ESR1 mutation, TP53 mutation, CDK4/6 inhibitor resistance, prior endocrine therapy, prior chemotherapy, prior radiotherapy, prior surgery, prior hormone therapy, and/or prior targeted therapy:

• Breast cancer with a PIK3CA mutation, hormone receptor-positive, HER2-negative, ESR1 mutation, TP53 mutation, CDK4/6 inhibitor resistance, prior endocrine therapy, prior chemotherapy, prior radiotherapy, prior surgery, prior hormone therapy, and/or prior targeted therapy treatment updates — RSS
• Breast cancer with a PIK3CA mutation, hormone receptor-positive, HER2-negative, ESR1 mutation, TP53 mutation, CDK4/6 inhibitor resistance, prior endocrine therapy, prior chemotherapy, prior radiotherapy, prior surgery, prior hormone therapy, and/or prior targeted therapy treatment updates — Atom
• Breast cancer with a PIK3CA mutation, hormone receptor-positive, HER2-negative, ESR1 mutation, TP53 mutation, CDK4/6 inhibitor resistance, prior endocrine therapy, prior chemotherapy, prior radiotherapy, prior surgery, prior hormone therapy, and/or prior targeted therapy treatment updates — JSON

Cite this brief

Drug Landscape (2026). Breast cancer with a PIK3CA mutation, hormone receptor-positive, HER2-negative, ESR1 mutation, TP53 mutation, CDK4/6 inhibitor resistance, prior endocrine therapy, prior chemotherapy, prior radiotherapy, prior surgery, prior hormone therapy, and/or prior targeted therapy — Treatment Landscape & Competitive Intelligence Brief. https://druglandscape.com/ci/disease/breast-cancer-with-a-pik3ca-mutation-hormone-receptor-positive-her2-negative-esr1-mutation-tp53-mutation-cdk4-6-inhibitor-resistance-prior-endocrine-therapy-prior-chemotherapy-prior-radiotherapy-prior-surgery-prior-hormone-therapy-and-or-prior-targeted-therapy. Accessed 2026-06-10.

Related

• Breast cancer with a PIK3CA mutation, hormone receptor-positive, HER2-negative, ESR1 mutation, TP53 mutation, CDK4/6 inhibitor resistance, prior endocrine therapy, prior chemotherapy, prior radiotherapy, prior surgery, prior hormone therapy, and/or prior targeted therapy full disease profile — treatment pathway, diagnostics, guidelines
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing