Rash & Diarrhea Prophylaxis With Capivasertib

Conditions

• Metastatic HR+/HER2- Breast Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Accepted

Interventions

• Capivasertib — DRUG
  400 mg orally, twice daily (BID), on 4-days-on/3-days-off schedule.
• Loperamide — DRUG
  2 mg orally once daily on capivasertib dosing days
• Fulvestrant — DRUG
  500 mg Administered intramuscularly every 14 days for the first three injections and every 28 days thereafter.
• Ceterizine — DRUG
  10 mg orally once a day, starting on Cycle 1 Day 1 and continued for the first eight weeks (each cycle=28 days)

Study Details

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.

Key Dates

Start date

Apr 30, 2026

Status verified

Feb 2026

Primary completion

Apr 30, 2027

Completion

Apr 30, 2029

Study Design

Enrollment

108 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Experimental: Rash and diarrhea prophylaxis
  All participants will receive capivasertib + fulvestrant. Capivasertib will be administered at 400 mg orally, twice daily (BID), on 4-days-on/3-days-off schedule. Fulvestrant will be administered at 500 mg intramuscularly (IM) every 14 days for the first three injections, and every 28 days thereafter. Participants in this arm will take cetirizine 10 mg orally once daily, and loperamide 2 mg orally once daily on capivasertib dosing days, starting on Cycle 1 Day 1 and continued for the first eight weeks (each cycle = 28 days).
• Experimental: Rash prophylaxis
  All participants will receive capivasertib + fulvestrant. Capivasertib will be administered at 400 mg orally, twice daily (BID), on 4-days-on/3-days-off schedule. Fulvestrant will be administered at 500 mg intramuscularly (IM) every 14 days for the first three injections, and every 28 days thereafter. Participants will take cetirizine 10 mg orally once daily, starting on Cycle 1 Day 1 and continued for the first eight weeks (each cycle = 28 days).

Primary Outcome Measure

Number of patients who experience grade 2 or greater diarrhea as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0 [ Time Frame: At the eight-week mark from the commencement of the capivasertib treatment in the study ]

Central Contacts

• Laura Kane
  773-369-6904
  [email protected]

Locations (1)

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