Oncology / Haematology

A Phase 3 Trial of Pembrolizumab plus Chemotherapy vs Placebo plus Chemotherapy for Chemotherapy-Candidate HR+/HER2- Metastatic Breast Cancer

Trial Name:  KEYNOTE:B49  PI: Dr Jacquelyn Thomson

 

Who can take part:

  • Patients with Has locally recurrent inoperable or metastatic HR+/HER2- breast cancer, which has not been previously treated with cytotoxic chemotherapy in the noncurative setting.
  • Has progressed on 2 or more lines of endocrine therapy for metastatic HR+/HER2- disease, with at least 1 given in combination with a CDK4/6 inhibitor, or
  • Has progressed on 1 line of endocrine therapy for metastatic HR+/HER2- disease and had a relapse within 24 months of definitive surgery for primary tumor while on adjuvant endocrine therapy. Prior treatment with a CDK4/6 inhibitor (in the metastatic and/or adjuvant setting) is required, or
  • If no prior treatment with a CDK 4/6 inhibitor, participants must have progressed within 6 months of starting 1 line of endocrine therapy for metastatic disease and had a relapse within 24 months of definitive surgery for primary tumor and while on adjuvant endocrine therapy.

Exclusion criteria:

  • Has breast cancer amenable to treatment with curative intent.

For further information please contact Dianne 9784 8224

Trial Phase

Non-drug Phase 1 Phase 2 Phase 3 Phase 4