Short-term Pre-OPerative Durvalumab (MEDI 4736) in Early Small Triple Negative Breast Cancer Patients (POP-Durva)

Recruiting Phase 2 Interventional Study
Early Small (cT1N0) Triple Negative Breast Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Female
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
200 (estimated)
Sponsor
Gustave Roussy, Cancer Campus, Grand Paris · Other
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About This Trial
This study aims to evaluate the efficacy and safety of preoperative Durvalumab in patients with early small (cT1N0) triple negative breast cancer tumors. This study will recruit patients with early HR-negative breast cancer all invasive types (ER \< 10%, PR \< 10%, HER2 negative) and TILs \>=5%, eligible for a short-term treatment with Durvalumab. A total of 200 patients are planned to be enrolled…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Patient should understand, sign, and date the written informed consent form (including the consent to collect tissue, blood and stool samples, as specified by the protocol) prior to any protocol-specific procedures performed. Patient should be able and willing to comply with s…
Contacts

Joana Mourato RIBEIRO, MD

+33(0)1 42 11 43 70

Joana-mourato.RIBEIRO@gustaveroussy.fr

CONTACT

Chloé SERHAL, PhD

+33(0)1 42 11 23 43

chloe.serhal@gustaveroussy.fr

CONTACT