Therapeutic Response Statement (Sensitivity)

This therapeutic response statement Supports the relationship that HER2-positive and PR positive status confers therapeutic sensitivity to Exemestane, Palbociclib, Trastuzumab in patients with Invasive Breast Carcinoma.

The U.S. Food and Drug Administration granted approval to palbociclib in combination with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance treatment of adult patients with hormone receptor-positive, human epidermal growth factor receptor 2-positive locally advanced or metastatic breast cancer following induction treatment. This indication is based on PATINA (NCT02947685), a randomized, open-label trial in which endocrine therapy consisted of either fulvestrant or aromatase inhibitors (anastrozole, letrozole, or exemestane).

This statement is based on a regulatory approval from the Food and Drug Administration:

IBRANCE is a kinase inhibitor indicated in combination with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance treatment of adult patients with HR-positive, HER2-positive locally advanced or metastatic breast cancer following induction treatment.

Citation

Pfizer. Ibrance (palbociclib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/207103s024lbl.pdf. Revised June 2026. Accessed October 13, 2026. Pfizer, Inc. Ibrance (palbociclib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/207103s024lbl.pdf. Revised June 2026. Accessed October 6, 2026.

Contributions

Date	Contributor	Description
2026-10-13	Van Allen lab	Initial curation of this indication into moalmanac-db.
2026-06-24	Food and Drug Administration	Indication received traditional approval.