Study on Preventing Rash and Diarrhea with Capivasertib in Breast Cancer Treatment
Sponsor: Maryam Lustberg
ClinicalTrials ID:NCT07426822
This clinical trial is testing ways to prevent common side effects like rash and diarrhea in patients taking capivasertib with fulvestrant for advanced hormone receptor-positive, HER2-negative breast cancer.
Patient Parameters
| Parameter | Options |
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Program Overview
The study aims to find out if using antihistamines and loperamide can help reduce the occurrence of significant rash and diarrhea in patients starting treatment with capivasertib. This could help patients stay on the medication longer and potentially improve their treatment outcomes.
Description
Capivasertib is a treatment option for patients with advanced hormone receptor-positive breast cancer. This study is exploring whether taking antihistamines and loperamide can prevent or reduce side effects like rash and diarrhea, which are common with this medication. By managing these side effects, patients may be able to continue their treatment longer and benefit more from it. The study involves participants who are eligible for capivasertib and fulvestrant treatment and will test if these preventive measures can lower the incidence of moderate to severe rash and diarrhea over eight weeks.
Eligibility Criteria
Inclusion Criteria
- Able to give informed consent and follow study requirements.
- Aged 18 years or older.
- Women (pre- or post-menopausal) and men with advanced breast cancer eligible for capivasertib and fulvestrant treatment.
- Cancer must be advanced or metastatic and not removable by surgery.
- Must have specific genetic changes in the cancer (PIK3CA/AKT1/PTEN alterations).
- Good overall health with a performance status of 0 or 1 and a life expectancy of at least 12 weeks.
- Must be able to swallow pills.
- Must agree to use effective contraception during and after the study if of childbearing potential.
Exclusion Criteria
- Have a type of cancer or condition that makes endocrine therapy unsuitable.
- Have had other cancers within the last five years, except for certain treated skin or cervical cancers.
- Have unresolved side effects from previous treatments.
- Have blood clotting issues or are on blood thinners that prevent certain injections.
- Have taken other cancer treatments recently without a proper break.
- Are using herbal or natural cancer treatments.
- Have had recent major surgery or radiation therapy.
- Are taking medications that interfere with study drugs.
- Have uncontrolled diabetes or high blood sugar.
- Have untreated or unstable brain or spinal cord cancer spread.
- Have inadequate blood cell counts or organ function.
- Have severe or uncontrolled health conditions, including infections like hepatitis or HIV.
- Have a history of lung disease or skin conditions that could worsen with capivasertib.
- Have allergies to study drugs or similar medications.
- Have digestive issues that affect medication absorption.
- Have mental health conditions that affect understanding or consent.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Yale University | 06510 | New Haven | Connecticut |
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