Study on the Effects of Inavolisib and Fulvestrant for Breast Cancer Patients
Sponsor: Hoffmann-La Roche
ClinicalTrials ID:NCT07368998
This clinical trial is testing the combination of two drugs, inavolisib and fulvestrant, to see if they are effective and safe for treating patients with a specific type of advanced breast cancer that has a PIK3CA mutation and is hormone receptor-positive but HER2-negative.
Patient Parameters
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Program Overview
The aim of this study is to determine how well the combination of inavolisib and fulvestrant works in treating patients with advanced breast cancer that has a specific genetic mutation (PIK3CA) and is hormone receptor-positive but HER2-negative. The study focuses on patients whose cancer has progressed after previous treatments with CDK inhibitors and hormone therapy.
Eligibility Criteria
Inclusion Criteria
- Have a confirmed diagnosis of hormone receptor-positive, HER2-negative breast cancer based on specific medical guidelines.
- Cancer must have progressed after or during treatment with CDK4/6 inhibitors and hormone therapy, with no more than one prior line of systemic therapy for advanced or metastatic cancer.
- Have measurable or evaluable cancer according to standard criteria.
- Be recommended for hormone-based therapy and not require chemotherapy at the start of the study, according to treatment guidelines.
- Have at least one PIK3CA mutation that qualifies for the study.
- Have a life expectancy of more than 6 months.
- Be willing and able to follow all study procedures, including completing questionnaires about their health.
Exclusion Criteria
- Have metaplastic breast cancer.
- Have received chemotherapy for recurrent or advanced breast cancer.
- Have Type 2 diabetes that requires ongoing treatment or any history of Type 1 diabetes.
- Have previously been treated with PI3K/Akt/mTOR inhibitors for advanced breast cancer.
- Require daily supplemental oxygen.
- Have active lung disease with symptoms, such as pneumonitis.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Los Angeles Cancer Network | 90017-4803 | Los Angeles | California |
| Astera Cancer Care East Brunswick | 08816 | East Brunswick | New Jersey |
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