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Rash & Diarrhea Prophylaxis with Capivasertib for Metastatic Breast Cancer

This study is looking at ways to reduce common side effects like rash and diarrhea when treating metastatic HR+/HER2- breast cancer. You might be eligible if you have this type of breast cancer and are able to take capivasertib, a medication that targets the AKT mechanism. The study combines capivasertib with fulvestrant, loperamide (for diarrhea), and cetirizine (for rash) to see if these additional medications can prevent severe rash or diarrhea. Researchers will measure how many patients experience grade 2 or higher rash or diarrhea after eight weeks of treatment. The study aims to help patients stay on capivasertib longer by reducing these side effects. The current recruitment status is unclear.

Study design
This is a randomized, multicenter, phase II clinical trial involving about 108 participants. It is designed to compare different strategies to prevent side effects.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary outcomes for rash and diarrhea are measured at the eight-week mark from the start of capivasertib treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07426822

Rash & Diarrhea Prophylaxis With Capivasertib

Recruiting
PHASE2Ages 18+InterventionalPrevention
Maryam Lustberg
~108 participants
Updated 2026-07-29 on ClinicalTrials.gov
What's tested:CapivasertibLoperamideFulvestrantCeterizine

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of patients who experience grade 2 or greater diarrhea as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Measured over At the eight-week mark from the commencement of the capivasertib treatment in the study
+1 more outcome measured

Conditions

Metastatic HR+/HER2- Breast Cancer

Explore related trials

Breast CarcinomaPIK3CA GenePTEN GeneRAC-Alpha Serine/Threonine Kinase

Where it's being run

1 sites across 1 states
Connecticut1

Study leadership

  • Maryam Lustberg, MD · PRINCIPAL_INVESTIGATOR · Yale University

Who to contact

Laura Kane
[email protected]
773-369-6904
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Aged ≥60 years of age, OR
Aged \<60 years of age and amenorrhoeic for at least 12 months following cessation of all exogenous hormonal treatments/chemotherapy/ovarian suppression/tamoxifen or similar. These participants should also have serum estradiol and follicle stimulating hormone (FSH) levels confirmed as being within the standard laboratory reference range for post-menopausal females, OR
Documented irreversible bilateral oophorectomy. 5. Metastatic or locally advanced disease with radiological or objective evidence of recurrence or progression; locally advanced disease must not be amenable to resection with curative intent. 6. Participants with metastatic breast cancer with one or more PIK3CA/AKT1/PTEN-alterations, as confirmed by local or central testing of tumor tissue and/or circulating tumor DNA (ctDNA). 7. Participants eligible for treatment with capivasertib and fulvestrant for metastatic breast cancer. 8. ECOG performance status 0 or 1 with no deterioration over the previous 2 weeks and life expectancy of ≥12 weeks. 9. Adequate hematologic, coagulation, hepatic, and renal parameters. 10. Participants must be able to swallow and retain oral medication. 11. Participants must adhere to the following reproductive and contraceptive requirements:

What this trial measures

  • Number of patients who experience grade 2 or greater diarrhea as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0At 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) v4.0At 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