Study on Alpelisib and Tucatinib for Patients with PIK3CA-Mutant HER2+ Metastatic Breast Cancer

Sponsor: Criterium, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05230810

Provider View

This clinical trial is testing a combination of two drugs, Alpelisib and Tucatinib, to see if they can help treat patients with a specific type of advanced breast cancer that has a PIK3CA mutation and is HER2-positive.

Patient Parameters

Program Overview

This study is exploring a new treatment for patients with advanced breast cancer that has a PIK3CA mutation and is HER2-positive. The trial will test the safety and effectiveness of combining two drugs, Alpelisib and Tucatinib, in patients whose cancer has spread or cannot be surgically removed. The study will also include patients with hormone receptor-positive (HR+) or hormone receptor-negative (HR-) breast cancer. For HR+ patients, the treatment will include an additional drug, Fulvestrant, to block hormone signals. The trial will first confirm the safety of the drug combination and then expand to see how well it works in controlling the cancer.

Description

This clinical trial is designed to test a new combination of drugs, Alpelisib and Tucatinib, in patients with advanced breast cancer that has a specific genetic mutation (PIK3CA) and is HER2-positive. The study is divided into two phases. In the first phase, researchers will determine the safest dose of the drug combination. In the second phase, they will evaluate how well the treatment works in controlling the cancer. Patients with both hormone receptor-positive (HR+) and hormone receptor-negative (HR-) breast cancer can participate. HR+ patients will also receive Fulvestrant to block hormone signals. The trial aims to find out if this combination can help manage the disease in patients whose cancer has spread or cannot be removed by surgery.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 and older.
  • Good overall health with a performance status of 0 or 1.
  • Life expectancy of more than 6 months.
  • Diagnosed with HER2-positive advanced breast cancer that cannot be surgically removed or has spread.
  • Cancer must have a PIK3CA mutation confirmed by an approved test.
  • Known hormone receptor status of the tumor.
  • Patients with either HR-/HER2+ or HR+/HER2+ breast cancer can join.
  • HR+/HER2+ patients must be post-menopausal or on ovarian suppression.
  • HR+/HER2+ patients must agree to take Fulvestrant.
  • Must have received at least two HER2-targeted treatments previously.
  • Have measurable or evaluable disease.
  • Meet specific criteria for brain metastases if present.
  • Adequate organ and bone marrow function.
  • Agree to a low glycemic diet and lifestyle changes if needed.
  • Willing to sign informed consent and comply with study requirements.

Exclusion Criteria

  • Cannot undergo MRI with contrast.
  • Pregnant or breastfeeding.
  • Recent cancer treatments or surgery within specified timeframes.
  • Certain untreated or symptomatic brain metastases.
  • Unresolved side effects from previous cancer treatments.
  • More than one line of certain targeted therapies in the metastatic setting.
  • Previous treatment with Alpelisib or similar drugs for more than 30 days.
  • Uncontrolled diabetes or recent pancreatitis.
  • Severe allergic reactions to certain medications.
  • Active infections requiring IV treatment.
  • Active hepatitis B, C, or HIV infections.
  • Inability to swallow pills or significant digestive issues.
  • Recent severe heart conditions or uncontrolled high blood pressure.
  • Other severe medical or psychiatric conditions that may interfere with the study.

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