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

Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
Study ID
NCT05215106
Phase
PHASE2
Status
Recruiting
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Conditions

  • Early Small (cT1N0) Triple Negative Breast Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab — DRUG
    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).

Study Details

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.

Key Dates

Start date
Dec 6, 2021
Status verified
Jul 2024
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
200 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Durvalumab
    All patients enrolled in the study will receive 2 administrations of durvalumab 10mg/kg monotherapy before any standard treatment.

Primary Outcome Measure

pCR rate after 2 administrations of durvalumab [ Time Frame: Assessed at Day 29 (for patients performing surgery) or at Day 22 (for patients starting neoadjuvant systemic treatment) ]

Central Contacts