Study of Palbociclib and Trastuzumab With Endocrine Therapy in HER2-positive Metastatic Breast Cancer
Status:
Recruiting
Trial end date:
2021-12-01
Target enrollment:
Participant gender:
Summary
PATRICIA is a phase II, open-label, multicentre, Simon's two-stage-design study of the
combination of palbociclib plus trastuzumab, with or without letrozole, in post-menopausal
patients with HER2-positive locally advanced or metastatic breast cancer (MBC) who have
received chemotherapy and treatment with trastuzumab for their metastatic disease. Cohorts A,
B1, and B2 based on their HR status and treatment allocation were planned.
Cohort A included patients with hormone receptor-negative, HER2 positive breast cancer, who
received trastuzumab + palbociclib.
Cohort B1 included patients with hormone receptor-positive, HER2 positive breast cancer, who
received trastuzumab + palbociclib.
Cohort B2 included patients with hormone receptor-positive, HER2 positive breast cancer, who
received trastuzumab + palbociclib + letrozole.
The aim of the PATRICIA study is to test the hypothesis that the addition of Palbociclib to
standard therapy is well tolerated and can provide a benefit in progression-free survival.
Based on interim results from this trial that support the benefit of CDK4 / 6 inhibition in
luminal disease, two additional cohorts will be included.