Clinical Trials Logo
  1. Home
  2. Triple Negative Breast Neoplasms
  3. NCT04251533

Study Assessing the Efficacy and Safety of Alpelisib + Nab-paclitaxel in Subjects With Advanced TNBC Who Carry Either a PIK3CA Mutation or Have PTEN Loss — EPIK-B3  

Triple Negative Breast Neoplasms Clinical Trial

Official title:
A Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Alpelisib (BYL719) in Combination With Nab-paclitaxel in Patients With Advanced Triple Negative Breast Cancer With Either Phosphoinositide-3-kinase Catalytic Subunit Alpha (PIK3CA) Mutation or Phosphatase and Tensin Homolog Protein (PTEN) Loss Without PIK3CA Mutation

Clinical Trial Summary

The purpose of this study is to determine whether treatment with alpelisib in combination with nab-paclitaxel is safe and effective in subjects with advanced triple negative breast cancer (aTNBC) who carry either a PIK3CA mutation (Study Part A) or have PTEN loss (Study Part B1) or PTEN loss without PIK3CA mutation (Study Part B2)

Clinical Trial Description

The recruitment of Part A was halted on 11-Nov-2022 due to slow recruitment. Since Part B1 did not meet its primary objective for confirmed overall response rate the Part B2 will not be initiated and the recruitment was halted for the entire study ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04251533
Study type Interventional
Source Novartis
Contact
Status Active, not recruiting
Phase Phase 3
Start date June 8, 2020
Completion date September 2, 2024
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04879849 - A Study of TAK-676 With Pembrolizumab After Radiation Therapy to Treat a Number of Cancers Phase 1
Recruiting NCT06057636 - Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study N/A
Withdrawn NCT02427581 - Safety and Immunogenicity of a Personalized Synthetic Long Peptide Breast Cancer Vaccine Strategy in Patients With Persistent Triple-Negative Breast Cancer Following Neoadjuvant Chemotherapy Phase 1
Completed NCT02789332 - Assessing the Efficacy of Paclitaxel and Olaparib in Comparison to Paclitaxel / Carboplatin Followed by Epirubicin/Cyclophosphamide as Neoadjuvant Chemotherapy in Patients With HER2-negative Early Breast Cancer and Homologous Recombination Deficiency Phase 2
Recruiting NCT05007106 - MK-7684A With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors (MK-7684A-005) (KEYVIBE-005) Phase 2
Recruiting NCT05544929 - A Study of Safety and Efficacy of KFA115 Alone and in Combination With Pembrolizumab in Patients With Select Advanced Cancers Phase 1
Recruiting NCT05208762 - A Study of SGN-PDL1V in Advanced Solid Tumors Phase 1
Completed NCT01969643 - A Safety Study of SGN-LIV1A in Breast Cancer Patients Phase 1
Terminated NCT04489940 - Bintrafusp Alfa in High Mobility Group AT-Hook 2 (HMGA2) Expressing Triple Negative Breast Cancer Phase 2
Not yet recruiting NCT06154109 - Comparative Efficacy of Xiaopi Granules and Decoction in Triple-negative Breast Cancer: a Randomized Controlled Trial Phase 2
Withdrawn NCT02539017 - The Clinical Significance of Cellular Immune Adjuvant Therapy of Triple Negative Breast Cancer Phase 2
Terminated NCT02720185 - Window of Opportunity Trial of Dasatinib in Operable Triple Negative Breast Cancers With nEGFR Phase 2
Completed NCT03092934 - A Study of AK-01 (LY3295668) in Solid Tumors Phase 1/Phase 2
Recruiting NCT04895709 - A Study of BMS-986340 as Monotherapy and in Combination With Nivolumab or Docetaxel in Participants With Advanced Solid Tumors Phase 1/Phase 2
Active, not recruiting NCT03036488 - Study of Pembrolizumab (MK-3475) Plus Chemotherapy vs Placebo Plus Chemotherapy as Neoadjuvant Therapy and Pembrolizumab vs Placebo as Adjuvant Therapy in Participants With Triple Negative Breast Cancer (TNBC) (MK-3475-522/KEYNOTE-522) Phase 3
Recruiting NCT05252390 - NUV-868 as Monotherapy and in Combination With Olaparib or Enzalutamide in Adult Patients With Advanced Solid Tumors Phase 1/Phase 2
Withdrawn NCT02685306 - A Study of Neoadjuvant Paclitaxel in Combination With Bavituximab in Early- Stage Triple- Negative Breast Cancer Phase 2
Recruiting NCT05435352 - Image-based AI Predictive Biomarkers for Precision Neoadjuvant Triple-negative Breast Cancer Treatment
Active, not recruiting NCT03997123 - Capivasertib+Paclitaxel as First Line Treatment for Patients With Locally Advanced or Metastatic TNBC Phase 3
Active, not recruiting NCT02926196 - Adjuvant Treatment for High-risk Triple Negative Breast Cancer Patients With the Anti-PD-l1 Antibody Avelumab Phase 3