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
Condition(s) studied
Investigational drug(s) / intervention(s)
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
Primary outcome measure(s)
- Progression-Free Survival (PFS) — Up to 3.7 years
PFS was defined as the time from randomization to the first occurrence of disease progression, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1 or death from any cause (whichever occurs first). Progressive disease (PD) was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum in the study, including baseline, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). The appearance of one or more new lesions was also considered progression. Data for participants without the occurrence of PD or death as of the clinical cutoff date (CCOD) were censored at the time of the last tumor assessment prior to the CCOD. Median PFS was calculated using the Kaplan-Meier methodology.
Trial sites (135)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 Italy
Other trials for the same condition
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 Italy