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NCT04191499 · ClinicalTrials.gov registry record · Phase 2
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
A Phase 2 study of Breast Cancer, sponsored by Hoffmann-La Roche.
- Active
- Registry status
- Phase 2
- Development phase
- 325
- Enrollment target
- 20
- Study locations
NCT04191499: Active Phase 2 study of Breast Cancer, sponsored by Hoffmann-La Roche.
NCT04191499 is a Phase 2 study of Breast Cancer that is active but no longer recruiting, run by Hoffmann-La Roche. The registered enrollment target is 325 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (88% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04191499, a Phase 2 study of Breast Cancer, is active but no longer recruiting, sponsored by Hoffmann-La Roche.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 325 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
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
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Fulvestrant
- DRUG Palbociclib
- DRUG Inavolisib
Study Locations (20)
Texas
- Texas Oncology - Central South - Austin
- Texas Tech University Health Sciences Center - El Paso
- Texas Oncology - Northeast Texas - Tyler
Other
- Centro Oncologico Korben - Ciudad Autonoma Buenos Aires
- Hosp Provincial D. Centenarios - Rosario
- UZ Leuven Gasthuisberg - Leuven
Tennessee
- Sarah Cannon Research Institute / Tennessee Oncology - Chattanooga
- Sarah Cannon Research Institute / Tennessee Oncology - Nashville
New South Wales
- Macquarie University Hospital - Macquarie Park
- Southern Medical Day Care Centre - Wollongong
Queensland
- Mater Adult Hospital - South Brisbane
- Princess Alexandra Hospital - Woolloongabba
Victoria
- Western Health - Fitzroy
- Peninsula and South Eastern Haematology and Oncology Group - Frankston
California
- Beverly Hills Cancer Center - Beverly Hills
Massachusetts
- Massachusetts General Hospital. - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 325 participants |
| Start Date | 2020-01-29 |
| Est. Completion | 2027-11-15 |
| Phase | Phase 2 |
What the registry record for NCT04191499 still lists
NCT04191499 is an interventional study that assigns participants to a tested intervention. The registered 325 participants enrollment target is mid-sized for trials with a published cap, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (88% lower).
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT04191499 names 20 study sites across 12 states, led by Texas, Other, Tennessee.
Frequently Asked Questions
What is clinical trial NCT04191499 about?
NCT04191499 is a clinical study titled "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". 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 br...
What is the current status of trial NCT04191499?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 325 participants. The study started on 2020-01-29. Estimated completion is 2027-11-15.
What conditions does trial NCT04191499 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT04191499?
The interventions under investigation include: Placebo (DRUG), Fulvestrant (DRUG), Palbociclib (DRUG), Inavolisib (DRUG).
Who is sponsoring clinical trial NCT04191499?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04191499 being conducted?
This trial has 20 study locations across California, Massachusetts, New York, North Carolina, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04191499's enrollment target sits among peer trials
325 262nd of 1224 higher than 962 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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