A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus Ribociclib Plus Fulvestrant in Participants With Advanced Breast Cancer
Public ClinicalTrials.gov record NCT07405801. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus Ribociclib Plus Fulvestrant in Patients With Endocrine- Resistant Hormone-Receptor-Positive, HER2-Negative Advanced Breast Cancer With Chromosome 8P Loss and Without a PIK3CA Mutation
Study identification
- NCT ID
- NCT07405801
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Lead sponsor
- Hoffmann-La Roche
- Industry
- Enrollment
- 80 participants
Conditions and interventions
Conditions
Interventions
- Fulvestrant Drug
- Inavolisib Drug
- Placebo Drug
- Ribociclib Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 6, 2026
- Primary completion
- Dec 18, 2028
- Completion
- Feb 25, 2030
- Last update posted
- Apr 19, 2026
2026 – 2030
United States locations
- U.S. sites
- 6
- U.S. states
- 2
- U.S. cities
- 6
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Avera Cancer Institute - Marshall | Marshall | Minnesota | 56258 | Recruiting |
| Avera Cancer Institute - Aberdeen | Aberdeen | South Dakota | 57401 | Recruiting |
| Avera Cancer Institute - Mitchell | Mitchell | South Dakota | 57301 | Recruiting |
| Avera Cancer Institute - Pierre, SD | Pierre | South Dakota | 57501 | Recruiting |
| Avera Cancer Institute | Sioux Falls | South Dakota | 57105 | Recruiting |
| AMG Oncology and Hematology Avera Cancer Institute - Yankton | Yankton | South Dakota | 57078 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 13 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07405801, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 19, 2026 · Synced May 5, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07405801 live on ClinicalTrials.gov.