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

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 progressi

Trial Details

NCT ID
NCT03424005
Phase
PHASE1 / PHASE2
Sponsor
Hoffmann-La Roche
Status
RECRUITING
Cancer Type
Triple Negative (TNBC) Breast Cancer
Interventions
  • Capecitabine
  • Atezolizumab
  • Ipatasertib
  • SGN-LIV1A
  • Bevacizumab
  • Chemotherapy (Gemcitabine + Carboplatin or Eribulin)
Locations (sample)
  • Duarte, California, United States|34.13945,-117.97729
  • La Jolla, California, United States|32.84727,-117.2742
  • Stanford, California, United States|37.42411,-122.16608
  • Longmont, Colorado, United States|40.16721,-105.10193
  • Tampa, Florida, United States|27.94752,-82.45843

Key Eligibility Criteria

  • Patients must meet all of the following criteria to qualify for Stage 1 (all cohorts) and to qualify for Stage 2 (2L CIT-naïve cohort):
  • Age \>/= 18 years at the time of signing Informed Consent Form
  • Eastern cooperative oncology group (ECOG) performance status of 0 or 1
  • Able to comply with the study protocol, in the investigator's judgment

For full eligibility, visit ClinicalTrials.gov.

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