A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Participants With Breast Cancer

This is a Phase Ib/II, open-label, multicenter, randomized umbrella study in participants with breast cancer. The study is designed with the flexibility to open new treatment arms as new treatments become available, close existing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, or modify the patient population. Cohort 1 will focus on participants with inoperable, locally advanced or metastatic, estrogen receptor-positive (ER+), HER2-negative breast cancer who had disease progression during or following treatment with a cyclin-dependent kinase 4/6 inhibitor

Trial Details

NCT ID
NCT04802759
Phase
PHASE1 / PHASE2
Sponsor
Hoffmann-La Roche
Status
RECRUITING
Cancer Type
HER2 Negative Breast Cancer
Interventions
  • Giredestrant
  • Abemaciclib
  • Ipatasertib
  • Inavolisib
  • Ribociclib
  • Everolimus
Locations (sample)
  • Duarte, California, United States|34.13945,-117.97729
  • Irvine, California, United States|33.66946,-117.82311
  • San Francisco, California, United States|37.77493,-122.41942
  • Santa Monica, California, United States|34.01949,-118.49138
  • Stanford, California, United States|37.42411,-122.16608

Key Eligibility Criteria

  • Inclusion Criteria for Cohort 1 (Stage 1 \[and Stage 2, only where indicated\]):
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Documented estrogen receptor-positive (ER+) tumor
  • Patients for whom endocrine therapy is recommended and treatment with cytotoxic chemotherapy is not indicated at time of entry into the study, as p…

For full eligibility, visit ClinicalTrials.gov.

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