Capivasertib+Fulvestrant asTreatment for Locally Advanced(Inoperable) or Metastatic HR+/HER2- Breast Cancer in Chinese Patients
brief summary
This is a multi-center, two-cohorts, phase IIIb study of Capivasertib+Fulvestrant in HR+/HER2-ABC who had disease recurrence/progression following 1-2L endocrine therapy. The Primary objective is to assess the efficacy of capi+ful by assessment of TFST (Time to first subsequent treatment) of PIK3CA/AKT1/PTEN-altered subgroup in cohort1.
detailed description
This study will enroll about 300 patients in 2 cohorts . Cohort1 will include patients without prior fulvestrant treated and Cohort2 will include patients who received fulvestrant as the first-line treatment and progression ≥6 months after the first dosing of fulvestrant. Approximately 195 patients will be enrolled in Cohort1 and 105 patients will be enrolled in Cohort2.
All patients will receive weekly capivasertib (400 mg, oral, twice daily; 4 days on and 3 days off) and fulvestrant (at the approved dose regimen \[500 mg intramuscular injections on Day 1 of Weeks 1 and 3 of Cycle 1, and then on Day 1, Week 1 of each cycle thereafter\]). All patients will attend a screening visit a maximum of 28 days prior to the start of study treatment.
official title
A Phase IIIb Single Arm, 2 Cohorts Study Assessing the Efficacy and Safety of Capivasertib+ Fulvestrant as Treatment for Locally Advanced(Inoperable) or Metastatic Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Breast Cancer Following Recurrence or Progression On or After Treatment With Endocrine Therapy in Chinese Patients