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NCT04208178 · ClinicalTrials.gov registry record · Phase 3
Study of Alpelisib (BYL719) in Combination With Trastuzumab and Pertuzumab as Maintenance Therapy in Patients With HER2-positive Advanced Breast Cancer With a PIK3CA Mutation
A Phase 3 study of Advanced HER2+Breast Cancer, sponsored by Novartis Pharmaceuticals.
- Active
- Registry status
- Phase 3
- Development phase
- 19
- Enrollment target
- 11
- Study locations
NCT04208178: Active Phase 3 study of Advanced HER2+Breast Cancer, sponsored by Novartis Pharmaceuticals.
NCT04208178 is a Phase 3 study of Advanced HER2+Breast Cancer that is active but no longer recruiting, run by Novartis Pharmaceuticals. The registered enrollment target is 19 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower). The trial reports 11 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04208178, a Phase 3 study of Advanced HER2+Breast Cancer, is active but no longer recruiting, sponsored by Novartis Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 19 participants
- Enrollment target
- 11
- Study locations
Study Summary
The purpose of this two part multicenter, randomized, double-blind, placebo-controlled, Phase III study is to evaluate the efficacy and safety of alpelisib compared to alpelisib matching-placebo in combination with trastuzumab and pertuzumab as maintenance treatment of patients with HER2-positive advanced breast cancer whose tumor harbors a PIK3CA mutation following induction therapy with a taxane in combination with trastuzumab and pertuzumab. Part 1 is the open-label, safety run-in part of the study, designed to confirm the recommended phase 3 dose (RP3D) dose of alpelisib in combination with trastuzumab and pertuzumab. Following Part 1, Part 2 will be initiated, which is the randomized, Phase III part of the study.
Primary Outcome
Incidence of DLTs during the first 6 weeks of treatment for each dose level associated with administration of alpelisib in combination with trastuzumab and pertuzumab
Conditions Studied
Interventions
- DRUG Trastuzumab
- DRUG Pertuzumab
- DRUG Alpelisib
- DRUG Alpelisib matching Placebo
Study Locations (11)
Other
- Novartis Investigative Site - Leuven
- Novartis Investigative Site - Liège
- Novartis Investigative Site - Shanghai
- Novartis Investigative Site - Saint-Herblain
- Novartis Investigative Site - Kuala Lumpur
Arkansas
- Highlands Oncology Group - Fayetteville
California
- University of California LA - Los Angeles
Jilin
- Novartis Investigative Site - Changchun
Hauts De Seine
- Novartis Investigative Site - Saint-Cloud
FI
- Novartis Investigative Site - Florence
Barcelona
- Novartis Investigative Site - L'Hospitalet de Llobregat
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2020-07-16 |
| Est. Completion | 2027-02-26 |
| Phase | Phase 3 |
What the registry record for NCT04208178 still lists
NCT04208178 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Advanced HER2+Breast Cancer appearing as the primary indexed condition, and to 4 interventions - of which Trastuzumab is the first listed.
NCT04208178 lists 11 locations in 7 states (Other, Arkansas, California).
Frequently Asked Questions
What is clinical trial NCT04208178 about?
NCT04208178 is a clinical study titled "Study of Alpelisib (BYL719) in Combination With Trastuzumab and Pertuzumab as Maintenance Therapy in Patients With HER2-positive Advanced Breast Cancer With a PIK3CA Mutation". The purpose of this two part multicenter, randomized, double-blind, placebo-controlled, Phase III study is to evaluate the efficacy and safety of alpelisib compared to alpelisib matching-placebo in combination with trastuzumab and pertuzumab as maintenance treatment of patients with HER2-positive ad...
What is the current status of trial NCT04208178?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 19 participants. The study started on 2020-07-16. Estimated completion is 2027-02-26.
What conditions does trial NCT04208178 study?
This clinical trial studies the following conditions: Advanced HER2+Breast Cancer.
What interventions are being tested in trial NCT04208178?
The interventions under investigation include: Trastuzumab (DRUG), Pertuzumab (DRUG), Alpelisib (DRUG), Alpelisib matching Placebo (DRUG).
Who is sponsoring clinical trial NCT04208178?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04208178 being conducted?
This trial has 11 study locations across Arkansas, California, Jilin, Hauts De Seine, FI. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04208178's enrollment target sits among peer trials
19 1970th of 2000 higher than 31 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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