Study on Inavolisib Treatments for Early-Stage, PIK3CA-Mutated Breast Cancer

Sponsor: Hoffmann-La Roche

Sponsor score: 40

ClinicalTrials ID:NCT07054190

Provider View

This clinical trial is testing the safety and effectiveness of inavolisib combined with other treatments for patients with early-stage breast cancer that has a specific genetic mutation (PIK3CA) and is estrogen receptor-positive and HER2-negative.

Patient Parameters

Program Overview

The purpose of this study is to evaluate how safe and effective inavolisib, when used in combination with other therapies, is for treating patients with early-stage breast cancer that has not been treated before. The breast cancer must have a specific mutation called PIK3CA, be estrogen receptor-positive, and HER2-negative. The study focuses on patients with Stage II-III breast cancer.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of Stage II-III breast cancer that can be operated on or not, according to specific medical guidelines.
  • Be a candidate for treatment before surgery and suitable for combination therapy with hormone treatments.
  • Be willing to have breast surgery (either mastectomy or breast-conserving surgery) after treatment, unless the cancer cannot be operated on.
  • Have a tumor that is estrogen receptor-positive, based on current medical guidelines.
  • Have a tumor that is HER2-negative, based on current medical guidelines.
  • Have a Ki-67 score of 5% or higher, as determined by local testing.
  • Have a confirmed PIK3CA mutation in the cancer.

Exclusion Criteria

  • Have Stage IV breast cancer, which means the cancer has spread to other parts of the body.
  • Have inflammatory breast cancer.
  • Have cancer in both breasts.
  • Have a history of certain types of breast cancer if they have been treated with systemic therapy or radiation to the same breast.
  • Have received any previous treatment for the breast cancer being studied, including surgery, radiation, or medication.
  • Have Type 2 diabetes that requires ongoing treatment or any history of Type 1 diabetes.

Locations

FACILITYZIPCITYSTATE
Community Clinical Trials92868OrangeCalifornia

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