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 (NCT04191499)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Beverly Hills Cancer Center — Beverly Hills, 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 (135 Sites)
Showing the first 25 of 135 sites.
- Beverly Hills Cancer Center — Beverly Hills, California
- Massachusetts General Hospital. — Boston, Massachusetts
- Memorial Sloan Kettering Cancer Center — New York, New York
- Wake Forest University Baptist Medical Center — Winston-Salem, North Carolina
- Sarah Cannon Research Institute / Tennessee Oncology — Chattanooga, Tennessee
- Sarah Cannon Research Institute / Tennessee Oncology — Nashville, Tennessee
- Texas Oncology - Central South — Austin, Texas
- Texas Tech University Health Sciences Center — El Paso, Texas
- Texas Oncology - Northeast Texas — Tyler, Texas
- Northwest Medical Specialties — Tacoma, Washington
- Centro de Investigaciones Médicas y Desarrollo LC S.R.L — Buenos Aires, Ciudad Autónoma de BuenosAires
- Centro Oncologico Korben — Ciudad Autonoma Buenos Aires,
- Hosp Provincial D. Centenarios — Rosario,
- Macquarie University Hospital — Macquarie Park, New South Wales
- Southern Medical Day Care Centre — Wollongong, New South Wales
- Mater Adult Hospital — South Brisbane, Queensland
- Princess Alexandra Hospital — Woolloongabba, Queensland
- Western Health — Fitzroy, Victoria
- UZ Leuven Gasthuisberg — Leuven,
- Santa Casa de Misericordia de Porto Alegre — Porto Alegre, Rio Grande do Sul
- Arthur J.E. Child Comprehensive Cancer Center-Calgary — Calgary, Alberta
- London Regional Cancer Program, London Health Sciences Centre, Baines Centre — London, Ontario
- Ottawa Hospital — Ottawa, Ontario
- Princess Margaret Cancer Center — Toronto, Ontario
- Hopital du Saint Sacrement — Québec, Quebec
💰 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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- 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
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.