Phase III Palbociclib With Endocrine Therapy vs. Capecitabine in HR+/HER2- MBC With Resistance to Aromatase Inhibitors
Status:
Completed
Trial end date:
2021-01-11
Target enrollment:
Participant gender:
Summary
This is an international (4 countries) randomized phase III study with 2 cohorts, patients
will be randomized 1:1 to endocrine therapy (cohort 1: exemestane 25 mg daily, cohort 2:
fulvestrant 500mg days 1 and 15 cycle 1 and then day 1 every 4 weeks) plus palbociclib (125
mg daily x3 weeks every 4 weeks) vs. capecitabine (1,250 mg/m2 twice daily x2 weeks every 3
weeks). Postmenopausal patients with HR+/HER2 MBC are eligible if resistant to previous
nonsteroidal aromatase inhibitors (NSAI) (letrozole or anastrozole) in cohort 1 or previous
aromatase inhibitors (AI) (letrozole, anastrozole or exemestane) in cohort 2 defined as:
recurrence while on or within 12 months after the end of adjuvant treatment with NSAI/AI or
progression while on or within 1 month after the end of treatment with NSAI/AI for MBC.
Previous chemotherapy is permitted either in the (neo)adjuvant setting and/or as first line
for MBC. Patients must have measurable disease according to RECIST 1.1 or bone lesions, lytic
or mixed, in the absence of measurable disease.