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Paclitaxel Plus Pembrolizumab vs. Paclitaxel Weekly in ER+ Luminal B Metastatic Breast Cancer

NCT03841747 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2024-03-12

No results posted yet for this study

Summary

PELICAN is a 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 ER-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 one of the two treatment arms:

* Pembrolizumab plus Paclitaxel
* Paclitaxel

Conditions

Interventions

DRUG

Pembrolizumab

200 mg Pembrolizumab IV Q3W.

DRUG

Paclitaxel

80 mg/m2 paclitaxel IV on Days 1,8, and 15 of each 28 day cycle.

Sponsors & Collaborators

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • European Institute of Oncology

    collaborator OTHER

  • Queen Mary University of London

    lead OTHER

Principal Investigators

  • Peter Schmid, MD PhD FRCP · Queen Mary University of London

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-31
Primary Completion
2023-06-30
Completion
2025-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03841747 on ClinicalTrials.gov