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Clinical Trials in the UK / NCT04191499
Active, not recruiting Phase 2/3

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 · tracked via the Priya Life Science UK tracker
Sponsor
Hoffmann-La Roche
Phase
Phase 2/3
Started
2020-01-29
Last updated
2026-09-11

Condition(s) studied

Breast Cancer

Investigational drug(s) / intervention(s)

InavolisibPlaceboPalbociclibFulvestrant

Inavolisib: Participants will receive oral inavolisib on Days 1-28 of each 28-day cycle.

Placebo: Participants will receive oral placebo on Days 1-28 of each 28-day cycle.

Palbociclib: Participants will receive oral palbociclib on Days 1-21 of each 28-day cycle.

Fulvestrant: Participants will receive intramuscular (IM) fulvestrant approximately every 4 weeks.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria * 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 Exclusion Criteria * 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

Primary outcome measure(s)

Trial sites (135)

FacilityCityRegionStatus
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 Argentina
Hosp Provincial D. Centenarios Rosario Argentina
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
Peninsula and South Eastern Haematology and Oncology Group Frankston Victoria
UZ Leuven Gasthuisberg Leuven Belgium
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
Beijing Cancer Hospital Beijing China
The First Hospital of Jilin University Changchun China
The First Affiliated Hospital, Chongqing Medical University Chongqing China
Fujian Medical University Union Hospital Fujian China
Sun Yet-sen University Cancer Center Guangzhou China
Zhejiang Cancer Hospital Hangzhou China
Harbin Medical University Cancer Hospital Harbin China
Fudan University Shanghai Cancer Center Shanghai China
Hebei Medical University Fourth Hospital Shijiazhuang China
Tianjin Cancer Hospital Tianjin China
Hubei Cancer Hospital Wuhan China
First Affiliated Hospital of Medical College of Xi'an Jiaotong University Xi'an China
Henan Cancer Hospital Zhengzhou China
Vejle Sygehus Vejle Denmark

+ 95 more sites — see the full list on the official registry below.

On this site

📄 Ibrance (palbociclib) drug profile →

More Hoffmann-La Roche trials in the UK

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04191499 on ClinicalTrials.gov ↗ ← All trials in the UK