A Phase II Trial to Improve Safety of Capivasertib for HR+/HER2- Metastatic Breast Cancer (SAFE-CAP)

NCT07426822 Phase 2 NOT_YET_RECRUITING

This is a randomized, multicenter, phase II clinical trial evaluating prophylactic strategies to mitigate common toxicities associated with capivasertib in combination with fulvestrant in participants with hormone receptor-positive (HR+), HER2-negative advanced breast cancer who are eligible for this treatment regimen.

Details

Lead sponsor	Maryam Lustberg
Phase	Phase 2
Status	NOT_YET_RECRUITING
Enrolment	108
Start date	2026-04
Completion	2029-04

Conditions

• Metastatic HR+/HER2- Breast Cancer

Interventions

• Capivasertib
• Loperamide
• Fulvestrant
• Ceterizine

Primary outcomes

• Number of patients who experience grade 2 or greater diarrhea as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0 — At the eight-week mark from the commencement of the capivasertib treatment in the study
  The study aims to evaluate the effectiveness of prophylactic strategies to mitigate diarrhea in patients receiving capivasertib in combination with fulvestrant for hormone receptor-positive (HR+), HER2-negative advanced breast cancer. Toxicities will be graded on the following scale: grade 1 mild, grade 2 moderate, grade 3 severe, grade 4 life threatening/disabling and grade 5 death related to AE.
• Number of patients who experience grade 2 or greater rash as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0 — At the eight-week mark from the commencement of the capivasertib treatment in the study
  The study aims to evaluate the effectiveness of prophylactic strategies to mitigate rash in patients receiving capivasertib in combination with fulvestrant for hormone receptor-positive (HR+), HER2-negative advanced breast cancer. Toxicities will be graded on the following scale: grade 1 mild, grade 2 moderate, grade 3 severe, grade 4 life threatening/disabling and grade 5 death related to AE

Countries

United States