Trials / Recruiting
RecruitingNCT07368998
To Study the Effect of Inavolisib in Combination With Fulvestrant in Participants With Breast Cancer
A Phase II, Randomized, Open-Label Study Evaluating Two Inavolisib Dose Levels in Combination With Fulvestrant in Participants With PIK3CA-Mutated, HR-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- Sponsor
- Hoffmann-La Roche · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the efficacy and safety of inavolisib in combination with fulvestrant compared with inavolisib in combination with fulvestrant in participants with PIK3CA-mutated, HR-positive, HER2-negative locally advanced or metastatic breast cancer (LA/mBC) in the post-cyclin-dependent kinase inhibitor (CDKi) setting.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Inavolisib | Participants will receive Inavolisib as per the schedule given in the protocol. |
| DRUG | Fulvestrant | Participants will receive Fulvestrant as per the schedule given in the protocol. |
Timeline
- Start date
- 2026-02-18
- Primary completion
- 2031-10-31
- Completion
- 2031-10-31
- First posted
- 2026-01-27
- Last updated
- 2026-04-13
Locations
16 sites across 5 countries: United States, Belgium, Spain, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07368998. Inclusion in this directory is not an endorsement.