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Rash & Diarrhea Prophylaxis With Capivasertib

NCT07426822 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2026-02-24

No results posted yet for this study

Summary

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.

Conditions

  • Metastatic HR+/HER2- Breast Cancer

Interventions

DRUG

Capivasertib

400 mg orally, twice daily (BID), on 4-days-on/3-days-off schedule.

DRUG

Loperamide

2 mg orally once daily on capivasertib dosing days

DRUG

Fulvestrant

500 mg Administered intramuscularly every 14 days for the first three injections and every 28 days thereafter.

DRUG

Ceterizine

10 mg orally once a day, starting on Cycle 1 Day 1 and continued for the first eight weeks (each cycle=28 days)

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Maryam Lustberg

    lead OTHER

Principal Investigators

  • Maryam Lustberg, MD · Yale University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2027-04-30
Completion
2029-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07426822 on ClinicalTrials.gov