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drugset / Trial / NCT03424005

A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer

NCT03424005 ↗

Phase 1/2 Recruiting 1132 enrolled Hoffmann-La Roche Gilead Sciences · collabPfizer · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

This is an umbrella study evaluating the efficacy and safety of multiple treatment combinations in participants with metastatic or inoperable locally advanced breast cancer. The study will be performed in two stages. During Stage 1, seven cohorts will be enrolled in parallel in this study: Cohort 1 will consist of programmed death-ligand 1 (PD-L1)-positive participants who have received no prior systemic therapy for metastatic or inoperable locally advanced triple-negative breast cancer (TNBC) (first-line \[1L\] PD-L1+ cohort). Cohort 2 will consist of participants who had disease progression during or following 1L treatment with chemotherapy for metastatic or inoperable locally-advanced TNBC and have not received cancer immunotherapy (CIT) (second-line \[2L\] CIT-naïve cohort). Cohort 3, 5, 6 and 7 will consist of participants with locally advanced or metastatic hormone receptor-positive (HR+), human epidermal growth factor receptor 2 (HER2)-negative disease with one or more PIK3CA mutations. Cohort 4 will consist of participants with locally advanced or metastatic HER2+ /HER2-low disease with one or more PIK3CA mutations who had disease progression on standard-of-care therapies (HER2+ /HER2-low cohort). In each cohort, eligible participants will initially be assigned to one of several treatment arms (Stage 1). During Stage 2, participants in the 2L CIT-naïve cohort who experience disease progression, loss of clinical benefit, or unacceptable toxicity during Stage 1 may be eligible to continue treatment with a different treatment combination, provided Stage 2 is open for enrollment and all eligibility criteria are met.

Timeline

Start
2018-03-30
Primary completion
2030-09-30
Completion
2030-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Abemaciclib Small molecule 150 mg Oral
Subject Atezolizumab Monoclonal antibody 840 mg Intravenous
Subject Atezolizumab Monoclonal antibody 1200 mg Intravenous
Subject Atirmociclib Small molecule — Oral
Subject Bevacizumab Monoclonal antibody 10 mg/kg Intravenous
Comparator Capecitabine Small molecule 1250 mg/m2 Oral
Subject Carboplatin Small molecule — Intravenous
Subject Empagliflozin Small molecule — Oral
Subject Eribulin Small molecule 1.4 mg/m2 Intravenous
Subject Fulvestrant Small molecule 500 mg Intramuscular
Subject Gemcitabine Small molecule 1000 mg/m2 Intravenous
Subject Giredestrant Small molecule 30 mg Oral
Subject Inavolisib Small molecule — Oral
Subject Ipatasertib Small molecule 400 mg Oral
Subject Letrozole Other / unclassified 2.5 mg Oral
Subject Metformin Small molecule 1000 mg Oral
Subject Paclitaxel Small molecule 100 mg/m2 Intravenous
Subject Palbociclib Small molecule 125 mg Oral
Subject Ribociclib Small molecule — Oral
Subject Sacituzumab Govitecan Monoclonal antibody 10 mg/kg Intravenous
Subject Selicrelumab Monoclonal antibody 16 mg Subcutaneous
Subject Tocilizumab Monoclonal antibody 8 mg/kg Intravenous
Subject Trastuzumab deruxtecan Monoclonal antibody 5.4 mg/kg Intravenous
Subject ladiratuzumab vedotin Unknown 2.5 mg/kg Intravenous

Indications

breast cancer