RecruitingPhase 1NCT04360941

PAveMenT: Palbociclib and Avelumab in Metastatic AR+ Triple Negative Breast Cancer

PAveMenT: Phase Ib Study of Palbociclib and Avelumab in Metastatic AR+ Triple Negative Breast Cancer


Sponsor

Royal Marsden NHS Foundation Trust

Enrollment

45 participants

Start Date

Aug 11, 2020

Study Type

INTERVENTIONAL

Summary

This clinical study is aiming to determine the safest doses and schedule for the combination of two drugs named palbociclib and avelumab. The study will also be investigating how effective the combination is for a subgroup of breast cancer patients whose cancer expresses the androgen receptor (AR) but not the oestrogen (hormone) or HER2 receptors. Palbociclib is a drug used in routine care for hormone-receptor (HR) positive and HER2 negative advanced breast cancer, the most common subtype of breast cancer. It is possible that the combination of palbociclib and avelumab will be a more effective cancer treatment than each drug separately, but this is unknown and this study is needed to establish the best dosage and schedule of each drug as well as how effective the combination is.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two drugs — palbociclib (a targeted drug that slows cell division) and avelumab (an immunotherapy drug) — in patients with a hard-to-treat form of breast cancer called androgen receptor-positive (AR+) triple-negative breast cancer. Triple-negative breast cancer does not respond to hormone therapies or HER2-targeted treatments, making new approaches urgently needed. **You may be eligible if:** - You have locally advanced or metastatic (spread) breast cancer that cannot be removed with surgery - You have been treated with at least one but no more than two prior chemotherapy regimens for advanced disease - If your cancer is ER-positive, you have also received at least one hormone therapy; if HER2-positive, at least one HER2-targeted therapy - Your cancer can be measured on imaging scans - Your blood counts and organ function are within required ranges **You may NOT be eligible if:** - You have not received prior treatment for advanced disease - You have had more than two prior chemotherapy regimens for advanced disease - Your organ function does not meet required levels Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPalbociclib

Highly selective oral inhibitor of CDK4 and CDK6.

DRUGAvelumab

Fully human IgG1 monoclonal antibody (mAb) binds to the PD-L1 cell surface ligand and blocks its interaction with the PD-1 cell surface receptor.


Locations(9)

The Christie NHS Foundation Trust

Manchester, Greater Manchester, United Kingdom

Addenbrooke's Hospital Cambridge University Hospitals NHS Foundation Trust

Cambridge, United Kingdom

Beatson West of Scotland Cancer Centre

Glasgow, United Kingdom

Hope Clinical Trials Cancer Centre

Leicester, United Kingdom

Barts Cancer Institute

London, United Kingdom

Royal Marsden NHS Foundation Trust

London, United Kingdom

University College London Hospitals NHS Foundation Trust

London, United Kingdom

Nottingham University Hospital

Nottingham, United Kingdom

Weston Park Hospital

Sheffield, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT04360941