Title: Clinical trial of alpelisib and tucatinib in patients with PIK3CA-mutant HER2+ metastatic breast cancer
Principal Investigator: Elena Shagisultanova, MD, of the University of Colorado in Denver
Description: Researchers are conducting a phase 1b/2 trial to test tucatinib in combination with alpelisib in patients with PIK3CA-mutant, HER2-positive, locally advanced unresectable or metastatic breast cancer.
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In the phase 1b portion of the trial, the tolerability and recommended phase 2 dose (RP2D) will be determined.
During each 28-day cycle, patients will receive tucatinib at 300 mg twice daily and alpelisib at 250 mg once daily. Patients with hormone receptor (HR)-positive disease will also receive standard doses of fulvestrant.
In phase 2, new patients will enroll at the RP2D, and phase 1b patients will be rolled over to phase 2. If a patient is on drug doses lower than the RP2D, their doses will not be increased. If a patient is on higher doses than the RP2D, their doses will be decreased to the RP2D.
The primary outcomes are the safety and tolerability of the combination in phase 1b and progression-free survival in phase 2. Secondary outcomes include pharmacokinetics, tumor response, duration of response, and the incidence, nature, and severity of adverse events.
To be eligible for this study, patients must be 18 years of age or older. They must have a histologically confirmed diagnosis of HER2-positive, locally advanced unresectable or metastatic breast cancer and documented presence of an activating mutation in PIK3CA in the tumor. For a complete list of eligibility criteria, please see the reference.
Status: Recruiting
This study is sponsored by Criterium, Inc., in collaboration with Novartis and Seagen Inc.
Reference
ClinicalTrials.gov. Clinical trial of alpelisib and tucatinib in patients with PIK3CA-mutant HER2+ metastatic breast cancer. NCT05230810. Accessed March 17, 2023.
