At a glance
ClinicalIndex Comparison Record- ✓Confirmed diagnosis of hormone receptor-positive (HR+), HER2-negative breast cancer
- ✓Metastatic or locally advanced disease not amenable to curative therapy
- ✓Disease progression during adjuvant endocrine therapy or within 12 months of completing adjuvant endocrine therapy with an aromatase inhibitor or tamoxifen
- ✓Must be receiving LHRH agonist therapy for at least 2 weeks prior to start of treatment if pre/peri-menopausal
- ✕Metaplastic breast cancer histology
- ✕History of leptomeningeal disease or carcinomatous meningitis
- ✕Any prior systemic therapy for metastatic breast cancer
- ✕Prior treatment with fulvestrant or selective estrogen-receptor degrader, except if used as neoadjuvant therapy for ≤6 months
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib Plus Palbociclib and Fulvestrant Versus Placebo Plus Palbociclib and Fulvestrant in Patients With PIK3CA-Mutant, Hormone Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer
In Brief
A Phase 2 clinical trial evaluating Inavolisib, Placebo, and 2 other interventions for Breast Cancer. Active but no longer recruiting, targeting 325 participants across 135 sites in 28 countries.
Signals
Detailed Summary
This study will evaluate the efficacy, safety, and pharmacokinetics of inavolisib in combination with palbociclib and fulvestrant compared with placebo plus palbociclib and fulvestrant in participants with PIK3CA-mutant, hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer whose disease progressed during treatment or within 12 months of completing adjuvant endocrine therapy and who have not received prior systemic therapy for metastatic disease.
Study Details
Timeline
Arms & Interventions
Participants will receive inavolisib, palbociclib, and fulvestrant.
Participants will receive placebo, palbociclib, and fulvestrant. Participants randomized to the placebo arm who are still deriving benefit from the study treatment will be given an optional opportunity to crossover to the inavolisib arm.
Interventions
Participants will receive oral inavolisib on Days 1-28 of each 28-day cycle.
Participants will receive oral placebo on Days 1-28 of each 28-day cycle.
Participants will receive oral palbociclib on Days 1-21 of each 28-day cycle.
Participants will receive intramuscular (IM) fulvestrant approximately every 4 weeks.