Maryam Lustberg
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.
Capivasertib is an important treatment option for patients with metastatic hormone receptor-positive breast cancer. Understanding how to decrease the incidence of adverse events will allow patients to stay on the medication longer, potentially deriving greater benefit, and may ultimately result in improved time to next treatment. The investigators hypothesize that cutaneous and diarrheal prophylaxis with antihistamine and loperamide for patients initiating capivasertib will reduce the incidence of grade 2 or greater rash and/or diarrhea at eight weeks.
Inclusion Criteria: 1. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the clinical study protocol. 2. Provision of signed and dated, written ICF prior to any mandatory study specific procedures, sampling, and analyses. 3. Participants must be aged ≥18 years at the time of signing the ICF. 4. Adult females, pre- and/or post-menopausal, and adult males: \- Pre-menopausal (and peri-menopausal i.e., those that do not meet the criteria for post-menopausal defined below) women can be en…
400 mg orally, twice daily (BID), on 4-days-on/3-days-off schedule.
2 mg orally once daily on capivasertib dosing days
500 mg Administered intramuscularly every 14 days for the first three injections and every 28 days thereafter.
10 mg orally once a day, starting on Cycle 1 Day 1 and continued for the first eight weeks (each cycle=28 days)
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