Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06635447
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-09
Brief Title:
CapivasertibFulvestrant asTreatment for Locally AdvancedInoperable or Metastatic HRHER2- Breast Cancer in Chinese Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase IIIb Single Arm 2 Cohorts Study Assessing the Efficacy and Safety of Capivasertib Fulvestrant as Treatment for Locally AdvancedInoperable or Metastatic Hormone Receptor Positive Human Epidermal Growth Factor Receptor 2 Negative HRHER2- Breast Cancer Following Recurrence or Progression On or After Treatment With Endocrine Therapy in Chinese Patients
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAPItrue
Brief Summary:
This is a multi-center two-cohorts phase IIIb study of CapivasertibFulvestrant in HRHER2-ABC who had disease recurrenceprogression following 1-2L endocrine therapy
The Primary objective is to assess the efficacy of capiful by assessment of TFST Time to first subsequent treatment in cohort1
The Primary objective is to assess the efficacy of capiful by assessment of TFST Time to first subsequent treatment in cohort1
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None