A Phase IIIB Study to Evaluate the Use of Capivasertib in Combination With Fulvestrant in Patients With Advanced Breast Cancer Who Have Relapsed/Progressed on ET and CDK4/6 Inhibitor Reflecting Real World Clinical Practice in Spain

Phase 3

Recruiting

• Conditions: Locally Advanced or Metastatic Breast Cancer
• Interventions: Drug: Fulvestrant; Drug: Capivasertib

• Registration Number: NCT06764186
• Lead Sponsor: AstraZeneca

Brief Summary

The purpose of this study is to evaluate the effectiveness and safety of capivasertib + fulvestrant treatment administration in patients with locally advanced (inoperable) or metastatic HR+ / HER2- breast cancer with PIK3CA/AKT1/PTEN-altered following recurrence or progression on or after endocrine therapy and CDK4/6 inhibitor.

Detailed Description

Phase IIIb, multicentre, single arm, Spain study assessing effectiveness/safety of capivasertib+fulvestrant in locally advanced (inoperable) or metastatic HR+/HER2- BC with the PIK3CA/AKT1/PTEN-altered following recurrence or progression on or after endocrine therapy and CDK4/6 inhibitor. Capivasertib will be administered as 400mg BD, 4 days on 3 days off in combination with fulvestrant at the approved dose of monthly 500mg (2 × 5mL IV), with an additional loading dose in Cycle 1.

Study Timeline

• Study First Submitted: 2024-11-28
• Study First Submitted QC: 2025-01-02
• Study Start: 2025-01-07
• Study First Posted: 2025-01-08
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-13
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Capivasertib + fulvestrant	Fulvestrant	Fulvestrant: 2 intramuscular injections of 500 mg given on Day 1 of Weeks 1 and 3 of cycle 1, and then on Day 1, Week 1 of each cycle thereafter. Capivasertib: 400 mg (2 oral tablets) BD given on an intermittent weekly dosing schedule. Dosed on Days 1 to 4 in each week of a 28-day treatment cycle.
Capivasertib + fulvestrant	Capivasertib	Fulvestrant: 2 intramuscular injections of 500 mg given on Day 1 of Weeks 1 and 3 of cycle 1, and then on Day 1, Week 1 of each cycle thereafter. Capivasertib: 400 mg (2 oral tablets) BD given on an intermittent weekly dosing schedule. Dosed on Days 1 to 4 in each week of a 28-day treatment cycle.

Primary Outcome Measures

Name	Time	Method
Time to next treatment (TTNT)	From start of date of first dose of capivasertib+fulvestrant treatment to date of the first subsequent anti-cancer therapy or death or up to within approximately 12 months after Last Subject Inclusion	Time to next treatment (TTNT1 is defined as the time from the date of first dose of capivasertib+fulvestrant until the first subsequent anti-cancer therapy after discontinuation of study treatment or death due to any cause).

Secondary Outcome Measures

Name	Time	Method
Number of patients with AEs.	From enrollment up to at least 30 days (+7 days) after last dose of capivasertib + fulvestrant treatment	Safety and tolerability will be evaluated in terms of AEs, SAEs, and AESIs.
Time to first Subsequent Chemotherapy (TFSC)	From start of capivasertib+fulvestrant treatment to the first Subsequent Chemotherapy, death, withdrawal of consent or the end of study (approximately 24 months)	TFSC is defined as the time from the date of first dose of capivasertib + fulvestrant treatment until the first date of the first cycle of the subsequent chemotherapy, or death from any cause.
Progression-free survival (PFS)	From date of first dose of Capivasertib + fulvestrant until date of disease progression, death, withdrawal of consent or the end of study (approximately 24 months)	PFS is defined as time from the first dose of capivasertib + fulvestrant treatment to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1-defined progressive disease as assess by the investigator or death due to any cause.
Objective Response Rate (ORR)	From start of capivasertib+fulvestrant treatment to progression/death or up to 6 months after Last Subject Inclusion	Objective Response Rate (ORR) using site investigator assessments according to RECIST 1.1.
Overall survival (OS)	From date of first dose of capivasertib + fulvestrant treatment until death, withdrawal of consent, or the end of the study (approximately 24 months).	OS is defined as the time from first dose of capivasertib + fulvestrant treatment until the date of death due to any cause.
Number of patients with change in EORTC QLQ C30 and QLQ-BR42, respectively	From start of capivasertib+fulvestrant treatment to first dose of subsequent line of treatment/death or up to within approximately 12 months after Last Subject Inclusion	Change from baseline in score on EORTC QLQ-C30 and EORTC QLQ-BR42 reported at enrollment and then throughout the prospective study follow-up to end of the capivasertib + fulvestrant
Time to deterioration	From start of capivasertib+fulvestrant treatment to first dose of subsequent line of treatment/death or up to within approximately 12 months after Last Subject Inclusion	Time to deterioration defined as the time from the date of the first dose of treatment until the date of the first clinically meaningful deterioration that is confirmed at a subsequent visit at least 14 days apart or death.
Number of patients with change from in PGI-S	From start of capivasertib+fulvestrant treatment to the end of the study (approximately 24 months)	Change from baseline in score on the PGI-S to assess how a patient perceives the overall severity of cancer symptoms over the past 7 days at study enrollment and then weekly throughout the prospective study follow-up on study treatment
Number of patients with change in PGI-II	From start of capivasertib+fulvestrant treatment to the end of the study (approximately 24 months)	Change from baseline in score on the PGI-TT to assess how a patient perceives the overall tolerability of the study treatment over the past 7 days at study enrollment and then weekly throughout the prospective study follow-up on study treatment
Number of patients with change in Daily bowel habits	From start of capivasertib+fulvestrant treatment to the end of the study (approximately 24 months)	Change from baseline in score on the Daily bowel habits diary (BSFS) to classify the stools based on their appearance at study enrollment and then daily oughout the prospective study follow-up on study treatment
Number of patients with change in ADAQ	From start of capivasertib+fulvestrant treatment to the end of the study (approximately 24 months)	Change from baseline in score on ADAQ to assess the adherence of capivasertib + fulvestrant treatment at study enrollment and then weekly throughout the prospective study follow-up on study treatment

Trial Locations

Locations (1)

Research Site; 🇪🇸 Zaragoza, Spain