Therapeutic Response

ER negative, HER2-negative, and PR negative status confers therapeutic sensitivity to Carboplatin in combination with Cyclophosphamide, Doxorubicin, Paclitaxel, and Pembrolizumab in patients with Invasive Breast Carcinoma.

Statements

Source and description
Keytruda (pembrolizumab) [package insert]. FDA.

The U.S. Food and Drug Administration granted approval to pembrolizumab in combination with chemotherapy for the neoadjuvant treatment, and then pembrolizumab continued as a single agent as adjuvant treatment after surgery, of patients with high-risk early-stage triple negative breast cancer (TNBC). This indication is based on KEYNOTE-522 (NCT03036488), a randomized (2:1), multicenter, double-blind, placebo-controlled trial where the chemotherapy regimen consisted of carboplatin, paclitaxel, doxorubicin, and cyclophosphamide.
Keytruda (pembrolizumab) [product information]. EMA.

The European Medicines Agency (EMA) has authorized pembrolizumab in combination with chemotherapy for the neoadjuvant treatment, and then continued as a monotherapy for the adjuvant treatment after surgery, of adult patients with locally advanced or early-stage triple-negative breast cancer at high risk of recurrence. This indication is based on KEYNOTE-522 (NCT03036488), a randomized (2:1), multicenter, double-blind, placebo-controlled trial where the chemotherapy regimen consisted of carboplatin, paclitaxel, doxorubicin, and cyclophosphamide.