Trials / Active Not Recruiting
Active Not RecruitingNCT04191499
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
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
- Status
- Active Not Recruiting
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 325 (actual)
- Sponsor
- Hoffmann-La Roche · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Inavolisib | Participants will receive oral inavolisib on Days 1-28 of each 28-day cycle. |
| DRUG | Placebo | Participants will receive oral placebo on Days 1-28 of each 28-day cycle. |
| DRUG | Palbociclib | Participants will receive oral palbociclib on Days 1-21 of each 28-day cycle. |
| DRUG | Fulvestrant | Participants will receive intramuscular (IM) fulvestrant approximately every 4 weeks. |
Timeline
- Start date
- 2020-01-29
- Primary completion
- 2023-09-29
- Completion
- 2027-11-15
- First posted
- 2019-12-09
- Last updated
- 2026-03-17
- Results posted
- 2024-10-09
Locations
136 sites across 28 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, China, Denmark, France, Georgia, Germany, Greece, Hong Kong, Hungary, Italy, Malaysia, New Zealand, Poland, Portugal, Russia, Singapore, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), Ukraine, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04191499. Inclusion in this directory is not an endorsement.