- A Study Evaluating the Efficacy and Safety of Inavolisib + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Participants With PIK3CA-Mutant, Hormone Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer — Active Not Recruiting • Phase II / Phase III….
- Adding inavolisib to standard breast cancer treatment improves outcomes in patients with specific genetic mutations and advanced hormone-receptor-positive disease.
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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. Conditions: Breast Cancer Interventions: Inavolisib, Placebo, Palbociclib, Fulvestrant Lead Sponsor: Hoffmann-La Roche Planned Enrollment: 325 participants