Status:
WITHDRAWN
Paclitaxel Plus Pembrolizumab vs. Paclitaxel Weekly in ER+ Luminal B Metastatic Breast Cancer
Lead Sponsor:
Queen Mary University of London
Collaborating Sponsors:
Merck Sharp & Dohme LLC
European Institute of Oncology
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief 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-p...
Eligibility Criteria
Inclusion
- Willing and able to provide written informed consent
- Ability to comply with the protocol
- Female ≥ 18 years of age
- Histologically confirmed metastatic or locally advanced breast cancer that is Luminal B, ER+ve, HER2-ve.
- Patients must have measurable disease.
- Representative formalin-fixed paraffin embedded breast tumour samples from the primary or recurrent cancer.
- ECOG performance status 0-1
- Adequate haematologic and end-organ function within 28 days prior to the first study treatment
- Patients of childbearing potential are eligible provided they have a negative serum or urine pregnancy test on Day 1 Cycle 1 (within 72 hours) of study treatment, preferably as close to the first dose as possible.
Exclusion
- Luminal A breast cancer
- Prior chemotherapy for advanced or metastatic disease
- Prior treatment with paclitaxel in the (neo)adjuvant setting within 12 months from the end of paclitaxel treatment and randomisation into this study
- Patients with neuropathy ≥ Grade 2
- Previous systemic treatment for other neoplasms within 5 years prior to randomisation.
- Patients with prior allogeneic stem cell or solid organ transplantation.
- Prior treatment with CD137 agonists, AKT inhibitors, anti-CTLA-4, anti-OX-40, anti-programmed death-1 (PD-1), or anti-PD-L1 therapeutic antibody or pathway-targeting agents.
- Patients must not have a diagnosis of immunodeficiency or receiving chronic systemic steroid therapy.
- Received therapeutic oral or intravenous antibiotics within 14 days prior to randomisation.
- Administration of a live vaccine within 30 days prior to the first dose of study drug.
- Treatment with systemic immunostimulatory agents (including but not limited to interferons or interleukin \[IL\] -2) within 28days or five half-lives of the drug, whichever is shorter, prior to randomisation.
- History of autoimmune disease.
- History of idiopathic pulmonary fibrosis, drug-induced pneumonitis, organizing pneumonia requiring steroids, or evidence of active pneumonitis on screening chest CT scan.
- Active infection requiring systemic therapy.
- History of HIV infection
- Known active hepatitis infection.
- Known history of active tuberculosis
Key Trial Info
Start Date :
December 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03841747
Start Date
December 1 2020
End Date
June 1 2025
Last Update
March 12 2024
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