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NCT05894239 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer
A Phase 3 study of Metastatic Breast Cancer, sponsored by Hoffmann-La Roche.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 230
- Enrollment target
- 20
- Study locations
NCT05894239: Recruiting Phase 3 study of Metastatic Breast Cancer, sponsored by Hoffmann-La Roche.
NCT05894239 is a Phase 3 study of Metastatic Breast Cancer that is actively recruiting participants, run by Hoffmann-La Roche. The registered enrollment target is 230 participants, above the 203-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (13% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05894239, a Phase 3 study of Metastatic Breast Cancer, is actively recruiting participants, sponsored by Hoffmann-La Roche.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 230 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will evaluate the efficacy and safety of inavolisib in combination with Phesgo (pertuzumab, trastuzumab, and rHuPH20 injection for subcutaneous use) compared with placebo in combination with Phesgo, as maintenance therapy, after induction therapy in participants with previously untreated HER2-positive advanced breast cancer (ABC).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Phesgo
- DRUG Inavolisib
- DRUG Taxane-based Chemotherapy
- DRUG Optional Endocrine Therapy of Investigator's Choice
Study Locations (20)
California
- Disney Family Cancer Center - Burbank
- City of Hope - Corona
- City of Hope Comprehensive Cancer Center - Duarte
- City of Hope at Irvine Lennar - Irvine
- Ellison Institute of Technology - Los Angeles
Texas
- Renovatio Clinical - El Paso - El Paso
- JPS Health Network - Fort Worth
- Lumi Research - Kingwood
- Renovatio Clinical - The Woodlands
Washington
- Kadlec Clinic Hematology and Oncology - Kennewick
- Swedish Medical Center - Seattle
Arizona
- Banner Health MD Anderson AZ - Gilbert
District of Columbia
- Georgetown Uni Hospital - Washington D.C.
Maryland
- Medstar Research Institute - Hyattsville
Massachusetts
- Dana Farber Cancer Institute - Boston
Michigan
- Henry Ford Hospital - Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 230 participants |
| Start Date | 2023-09-08 |
| Est. Completion | 2032-12-28 |
| Phase | Phase 3 |
What NCT05894239 shows while recruiting
NCT05894239 is an interventional study that assigns participants to a tested intervention. The registered 230 participants enrollment target is mid-sized for trials with a published cap, above the 203-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (13% higher).
The record links to 1 condition, with Metastatic Breast Cancer appearing as the primary indexed condition, and to 5 interventions - of which Placebo is the first listed.
NCT05894239 names 20 study sites across 12 states, led by California, Texas, Washington.
Frequently Asked Questions
What is clinical trial NCT05894239 about?
NCT05894239 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer". This study will evaluate the efficacy and safety of inavolisib in combination with Phesgo (pertuzumab, trastuzumab, and rHuPH20 injection for subcutaneous use) compared with placebo in combination with Phesgo, as maintenance therapy, after induction therapy in participants with previously untreated ...
What is the current status of trial NCT05894239?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 230 participants. The study started on 2023-09-08. Estimated completion is 2032-12-28.
What conditions does trial NCT05894239 study?
This clinical trial studies the following conditions: Metastatic Breast Cancer.
What interventions are being tested in trial NCT05894239?
The interventions under investigation include: Placebo (DRUG), Phesgo (DRUG), Inavolisib (DRUG), Taxane-based Chemotherapy (DRUG), Optional Endocrine Therapy of Investigator's Choice (DRUG).
Who is sponsoring clinical trial NCT05894239?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05894239 being conducted?
This trial has 20 study locations across Arizona, California, District of Columbia, Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Metastatic 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 NCT05894239's enrollment target sits among peer trials
230 26th of 139 higher than 114 of 139 other Metastatic Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic 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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