RecruitingPhase 2NCT05215106

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


Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Enrollment

200 participants

Start Date

Dec 6, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

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 in the study and which will receive 2 administrations of durvalumab 10mg/kg. After study treatment, patients: * In whom surgery is the first standard treatment strategy (i.e. after study treatment) no biopsy is required at the end-of-treatment visit. * In whom neo adjuvant therapy is the first standard treatment strategy (i.e. after study treatment) a breast ultrasound guided biopsy is mandatory at the EoT visit. If the biopsy-proven residual disease is demonstrated, patients will have the option to receive standard neoadjuvant therapy at the discretion of the treating investigator. Those with a complete response may proceed directly to surgery.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a single dose of durvalumab (an immunotherapy drug) given before surgery can improve outcomes in women with early-stage triple-negative breast cancer (TNBC) — a type of breast cancer that lacks the three most common receptors and is typically harder to treat. **You may be eligible if...** - You are a woman aged 18 or older - You have been newly diagnosed with stage I triple-negative breast cancer (ER less than 10%, PR less than 10%, HER2 negative) - Your tumor has immune cells present (tumor infiltrating lymphocytes, or TILs, of 5% or more) - Your tumor is small (stage I, T1N0) with no spread to lymph nodes - You have not received any prior treatment for this cancer - Your blood counts and organ function are within required levels **You may NOT be eligible if...** - You have had prior systemic cancer therapy or radiation for this breast cancer - You have a known allergy to durvalumab - You have had an organ transplant or stem cell transplant - You have active autoimmune disease, HIV infection, or pulmonary fibrosis - You are pregnant or breastfeeding 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

DRUGDurvalumab

Following preparation of durvalumab, the entire contents of the IV bag should be administered as an IV infusion over approximately 60 minutes (±5 minutes), using a 0.2μm in-line filter (or add-on filter).


Locations(3)

Institut Bergonié

Bordeaux, France

Centre Léon Berard

Lyon, France

Gustave Roussy

Villejuif, France

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NCT05215106