Trials / Recruiting
RecruitingNCT07054190
A Study to Test Inavolisib Treatments in Participants With Early-Stage, PIK3CA-Mutated Breast Cancer
A Phase II, Open-Label, Multicenter Study Evaluating the Safety and Efficacy of Neoadjuvant Treatment With Inavolisib Combinations in Patients With Untreated, Early-stage, PIK3CA-Mutated Breast Cancer
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- Hoffmann-La Roche · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study will evaluate the safety and efficacy of inavolisib combination therapies in participants with untreated, PIK3CA-mutated, Stage II-III, estrogen receptor (ER)-positive, Human Epidermal Growth Factor Receptor 2 (HER2)-negative breast cancer (BC).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Inavolisib | Inavolisib will be administered as per the schedule specified in the arms |
| DRUG | Ribociclib | Ribociclib will be administered as per the schedule specified in the arms |
| DRUG | Letrozole | Letrozole will be administered as per the schedule specified in the arms |
Timeline
- Start date
- 2025-09-09
- Primary completion
- 2027-07-31
- Completion
- 2027-09-28
- First posted
- 2025-07-08
- Last updated
- 2026-03-31
Locations
27 sites across 6 countries: Argentina, Brazil, Canada, Germany, South Korea, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07054190. Inclusion in this directory is not an endorsement.