Title: A Phase II, randomized study of paclitaxel weekly plus pembrolizumab versus paclitaxel weekly in ER-positive, Luminal B metastatic breast cancer
Disease site: ER-positive, Luminal B metastatic breast cancer
Status: In set up

Trial Design: Randomised phase II trial that aims to evaluate the efficacy and safety of paclitaxel plus pembrolizumab relative to paclitaxel alone, in patients with locally advanced or metastatic oestrogen receptor positive, HER2-negative, Luminal B breast cancer who have received no prior chemotherapy for advanced or metastatic disease. Patients will be randomised 2:1 to either pembrolizumab plus paclitaxel vs paclitaxel alone.  Randomisation will be stratified by centrally assessed PD-L1 expression and the presence of visceral metastases. Paclitaxel treatment will be continued for at least 6 cycles unless there is evidence of disease progression Pembrolizumab treatment will not exceed 2 years. On completion of study treatment patients will enter a survival follow-up period during which data on cancer therapy, disease status and survival status will be collected.

Trial details

Chief Investigator: Prof P. Schmid
Trial contact:
Clinical not available
EudraCT: 2018-000188-10
Sponsor: Queen Mary University of London
Participating countries: UK
Source of funding: Merck Sharp & Dohme Corp. (funding and study drug)

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