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

Running, not enrolling · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT04191499

Run by

Hoffmann-La Roche

People needed

325

Starts

2020-01-29

Expected to finish

2027-11-15

Last updated by the study team

2026-06-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Confirmed diagnosis of HR+/HER2- breast cancer
• Metastatic or locally advanced disease not amenable to curative therapy
• Progression of disease during adjuvant endocrine treatment or within 12 months of completing adjuvant endocrine therapy with an aromatase inhibitor or tamoxifen
• Receiving LHRH agonist therapy for at least 2 weeks prior to Day 1 of Cycle 1 if pre/peri-menopausal
• Confirmation of biomarker eligibility (detection of specified mutation(s) of PIK3CA via specified test)
• Consent to provide fresh or archival tumor tissue specimen
• Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1); evaluable "bone-only" disease is not eligible; "bone-only" disease with at least one measurable, soft-tissue component, even if considered disease that is limited to bone but has lytic or mixed lytic/blastic lesions and at least one measurable soft-tissue component per RECIST v1.1 may be eligible
• Eastern Cooperative Oncology Group Performance Status of 0 or 1
• Life expectancy of > 6 months
• Adequate hematologic and organ function within 14 days prior to initiation of study treatment

You may not qualify if…

• Metaplastic breast cancer
• Any history of leptomeningeal disease or carcinomatous meningitis
• Any prior systemic therapy for metastatic breast cancer
• Prior treatment with fulvestrant or any selective estrogen-receptor degrader, with the exception of participants that have received fulvestrant or any selective estrogen-receptor degrader as part of neoadjuvant therapy only and with treatment duration of no longer than 6 months
• Prior treatment with any PI3K, AKT, or mTOR inhibitor, or any agent whose mechanism of action is to inhibit the PI3K-AKT-mTOR pathway
• Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes
• Known and untreated, or active CNS metastases. Patients with a history of treated CNS metastases may be eligible
• Active inflammatory or infectious conditions in either eye, or any eye conditions expected to require surgery during the study treatment period
• Symptomatic active lung disease, or requiring daily supplemental oxygen
• History of inflammatory bowel disease or active bowel inflammation
• Anti-cancer therapy within 2 weeks before study entry
• Investigational drug(s) within 4 weeks before randomization
• Prior radiotherapy to >= 25% of bone marrow, or hematopoietic stem cell or bone marrow transplantation
• Chronic corticosteroid therapy or immunosuppressants
• Pregnant, lactating, or breastfeeding, or intending to become pregnant during the study or within 2 weeks after the final dose of study treatment
• Major surgical procedure, or significant traumatic injury, within 28 days prior to Day 1 of Cycle 1

Where it is running

• Massachusetts General Hospital. — Boston, Massachusetts, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Wake Forest University Baptist Medical Center — Winston-Salem, North Carolina, United States
• Sarah Cannon Research Institute / Tennessee Oncology — Chattanooga, Tennessee, United States
• Sarah Cannon Research Institute / Tennessee Oncology — Nashville, Tennessee, United States
• Texas Oncology - Central South — Austin, Texas, United States
• Texas Tech University Health Sciences Center — El Paso, Texas, United States
• Texas Oncology - Northeast Texas — Tyler, Texas, United States
• Northwest Medical Specialties — Tacoma, Washington, United States
• Centro de Investigaciones Médicas y Desarrollo LC S.R.L — Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina
• Centro Oncologico Korben — Ciudad Autonoma Buenos Aires, Argentina
• Hosp Provincial D. Centenarios — Rosario, Argentina
• Macquarie University Hospital — Macquarie Park, New South Wales, Australia
• Southern Medical Day Care Centre — Wollongong, New South Wales, Australia
• Mater Adult Hospital — South Brisbane, Queensland, Australia
• Princess Alexandra Hospital — Woolloongabba, Queensland, Australia
• Western Health — Fitzroy, Victoria, Australia
• UZ Leuven Gasthuisberg — Leuven, Belgium
• Santa Casa de Misericordia de Porto Alegre — Porto Alegre, Rio Grande do Sul, Brazil
• Arthur J.E. Child Comprehensive Cancer Center-Calgary — Calgary, Alberta, Canada
• London Regional Cancer Program, London Health Sciences Centre, Baines Centre — London, Ontario, Canada
• Ottawa Hospital — Ottawa, Ontario, Canada
• Princess Margaret Cancer Center — Toronto, Ontario, Canada
• Hopital du Saint Sacrement — Québec, Quebec, Canada
• Beverly Hills Cancer Center — Beverly Hills, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.