Study identifier:D3612R00016
ClinicalTrials.gov identifier:NCT06635447
EudraCT identifier:N/A
CTIS identifier:N/A
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
Breast Cancer
Phase 3
No
Capivasertib, Fulvestrant
All
560
Interventional
18 Years - n/a
Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Mar 2025 by AstraZeneca
AstraZeneca
-
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) in cohort1.
This study will enroll 560 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 400 patients will be enrolled in Cohort1 and 160 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.
Location
Status
Location
Nanjing, China, 210029
Status
Recruiting
Location
Beijing, China, 100071
Status
Recruiting
Location
Kashgar, China, 844099
Status
Not yet recruiting
Location
Jinan, China, 250012
Status
Recruiting
Location
Xuzhou, China, 221005
Status
Recruiting
Location
Hefei, China, 230031
Status
Recruiting
Location
Fuzhou, China, 350001
Status
Recruiting
Location
Shantou, China, 515063
Status
Recruiting
Arms | Assigned Interventions |
---|---|
Experimental: Cohort 1 Capivasertib+Fulvestrant | Drug: Capivasertib 400 mg, oral, twice daily; 4 days on and 3 days off Other Name: AZD5363 Drug: Fulvestrant Fulvestrant IV |
Experimental: Cohort 2 Capivasertib+Fulvestrant | Drug: Capivasertib 400 mg, oral, twice daily; 4 days on and 3 days off Other Name: AZD5363 Drug: Fulvestrant Fulvestrant IV |
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