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 (NCT07405801)
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
🩺 Plain-English Summary (8th-Grade Level)
A study to evaluate the efficacy and safety of triplet combination of inavolisib plus ribociclib and fulvestrant versus placebo plus ribociclib and fulvestrant in the first-line setting in participants with endocrine-therapy-resistant hormone receptor (HR)-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC).
Who can join: Review the eligibility criteria below.
Location: Los Angeles Cancer Network - Anaheim — Anaheim, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (54 Sites)
Showing the first 25 of 54 sites.
- Los Angeles Cancer Network - Anaheim — Anaheim, California
- Stanford Cancer Institute — Palo Alto, California
- Avera Cancer Institute - Marshall — Marshall, Minnesota
- Avera Cancer Institute - Aberdeen — Aberdeen, South Dakota
- Avera Cancer Institute - Mitchell — Mitchell, South Dakota
- Avera Cancer Institute - Pierre, SD — Pierre, South Dakota
- Avera Cancer Institute — Sioux Falls, South Dakota
- AMG Oncology and Hematology Avera Cancer Institute - Yankton — Yankton, South Dakota
- Inst. Alexander Fleming — Buenos Aires,
- Centro Oncologico Korben — Caba,
- Centro Médico Fleischer — Capital Federal,
- Sanatorio de la Mujer — Rosario,
- Hospital Santa Rita de Cassia Vitoria — Vitória, Espírito Santo
- Hospital Brasilia — Brasília, Federal District
- Ictrials Pesquisa e Desenvolvimento — Curitiba, Paraná
- Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda — São Paulo, São Paulo
- Ottawa General Hospital — Ottawa, Ontario
- Sunnybrook Health Science Centre — Toronto, Ontario
- CIUSSS du Saguenay Lac-Saint-Jean, Chicoutimi Hospital — Chicoutimi, Quebec
- McGill University — Montreal, Quebec
- Centre Oscar Lambret — Lille,
- Centre Leon Berard — Lyon,
- Institut Paoli Calmettes — Marseille,
- Institut Régional du Cancer de Montpellier — Montpellier,
- Institut Universitaire du Cancer - Oncopole Toulouse (IUCT-O) — Toulouse,
📞 Contact the Study Coordinator
Phone: (888) 662-6728
Email: global-roche-genentech-trials@gene.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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- [177Lu]Lu-NeoB in Combination With Ribociclib and Fulvestrant in Participants With ER+, HER2- and GRPR+ Advanced Breast Cancer — Los Angeles, California
- Evaluation And Risk Assessment For Persistent Postsurgical Pain After Breast Surgery — Durham, North Carolina
- TACTIVE-U: A Study to Learn About the Study Medicine (Vepdegestrant) When Given With Other Medicines in People With Advanced or Metastatic Breast Cancer (Sub-Study B) — Palo Alto, California
- A Multi Modality Surveillance Program for Women At High Risk for Breast Cancer — Chicago, Illinois
- ATOP TRIAL: T-DM1 in HER2 Positive Breast Cancer — Duarte, California
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.