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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 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. The trial reports 11 study locations across 7 states.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04208178
The ClinicalTrials.gov registry entry for NCT04208178 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
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 reports 11 study locations spanning 7 distinct geographic areas - top geographies include 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.
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