Study on Alpelisib with Trastuzumab and Pertuzumab for Maintenance Therapy in HER2-positive Advanced Breast Cancer with PIK3CA Mutation
Sponsor: Novartis Pharmaceuticals
ClinicalTrials ID:NCT04208178
This clinical trial is testing whether adding the drug Alpelisib to the standard treatment of Trastuzumab and Pertuzumab can help maintain control of advanced HER2-positive breast cancer with a PIK3CA mutation after initial treatment.
Patient Parameters
| Parameter | Options |
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Program Overview
The study aims to evaluate the effectiveness and safety of Alpelisib, a drug used in combination with Trastuzumab and Pertuzumab, for patients with advanced HER2-positive breast cancer that has a PIK3CA mutation. The trial is divided into two parts: Part 1 is an open-label phase to determine the best dose of Alpelisib, and Part 2 is a randomized phase to compare Alpelisib with a placebo. However, the study was stopped early due to changes in breast cancer treatment approaches, not because of safety concerns. Patients benefiting from the treatment in Part 1 can continue, while those in Part 2 will be informed of their treatment group and may continue based on their doctor's assessment.
Description
The study was stopped early on December 7, 2022, due to changes in treatment options for HER2-positive breast cancer, not because of any new safety issues. Patients in Part 1 who are benefiting from the treatment can continue with Alpelisib, Trastuzumab, and Pertuzumab after discussing with their doctor. In Part 2, patients will be informed about their treatment group. Those receiving Alpelisib can continue if it's beneficial, while those on the placebo will not switch to Alpelisib but can continue with Trastuzumab and Pertuzumab if it's helping them.
Eligibility Criteria
Inclusion Criteria
- Have advanced HER2-positive breast cancer that cannot be surgically removed or has spread to other parts of the body.
- Have completed up to 8 cycles of initial treatment with a taxane drug (like docetaxel, paclitaxel, or nab-paclitaxel) along with Trastuzumab and Pertuzumab. Fewer cycles are allowed if the taxane was stopped due to side effects.
- Have a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Have adequate bone marrow and organ function.
- For Part 2: Have a PIK3CA mutation in the tumor, confirmed by a local or central lab test.
Exclusion Criteria
- Have inflammatory breast cancer at the start of the study.
- Show signs of cancer progression during initial treatment before starting Alpelisib.
- Have uncontrolled diabetes or type I diabetes.
- Have a history of acute pancreatitis in the past year or chronic pancreatitis.
- Have significant heart disease or recent heart problems.
- Have a history of severe skin reactions like Steven-Johnson Syndrome.
- Have lung conditions like pneumonitis or interstitial lung disease.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Highlands Oncology Group | 72703 | Fayetteville | Arkansas |
| University of California LA | 90095 | Los Angeles | California |
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