ClinicaliQ Trial Snapshot
- A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy — Recruiting • Phase III • Oncology….
- What is being tested: Inavolisib combined with fulvestrant versus alpelisib combined with fulvestrant in HR-positive, HER2-negative, PIK3CA-mutated breast cancer patients who have progressed after prior CDK4/6 inhibitor and endocrine therapy combination treatment.
- Patient eligibility overview: Participants must have locally advanced or metastatic HR-positive, HER2-negative breast cancer with confirmed PIK3CA mutations and documented progression following CDK4/6 inhibitor plus endocrine combination therapy.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
This is a Phase III, multicenter, randomized, open-label, global study designed to evaluate the efficacy and safety of inavolisib plus fulvestrant compared with alpelisib plus fulvestrant in patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2) -negative, PIK3CA-mutated, locally advanced (LA) or metastatic breast cancer (mBC), who progressed during or after cyclin dependent kinase 4/6i (CDK4/6i)-based therapy. Enrollment for the main study is now complete.
Eligibility Snapshot
- for Main Study and Sub-study: * If pre/perimenopausal women and men treatment with luteinizing hormone-releasing hormone (LHRH) agonist therapy beginning at least 2 weeks prior to Day 1 of Cycle 1 * Histologically or cytologically confirmed adenocarcinoma of the breast that is locally advanced or metastatic and is not amenable to surgical or radiation therapy with curative intent * Documented HR +/ HER2- tumor according to American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines * Confirmation of biomarker eligibility: detection of specified mutation(s) of PIK3CA via specified test * Disease progression after or during treatment with a combination of CDK4/6i and endocrine therapy: 6 months * Adequate hematologic and organ function prior to initiation of study treatment
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.