Actively Recruiting
Short-term Pre-OPerative Durvalumab (MEDI 4736) in Early Small Triple Negative Breast Cancer Patients (POP-Durva)
Led by Gustave Roussy, Cancer Campus, Grand Paris · Updated on 2024-07-08
200
Participants Needed
3
Research Sites
234 weeks
Total Duration
On this page
Sponsors
G
Gustave Roussy, Cancer Campus, Grand Paris
Lead Sponsor
A
AstraZeneca
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Short-term Pre-OPerative Durvalumab (MEDI 4736) in Early Small Triple Negative Breast Cancer Patients (POP-Durva)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 years or older
- Histologically confirmed untreated invasive breast carcinoma with ER < 10%, PR < 10%, HER2 negative
- Tumor infiltrating lymphocytes (TILs) of 5% or greater in breast tumor biopsy
- Breast cancer clinical stage I (cT1N0) by imaging; bilateral, multicentric, and multifocal tumors allowed if evaluations are done on the same target lesion
- No metastatic disease or lymph node involvement
- ECOG performance status 0 or 1
- Negative pregnancy test within 2 weeks (serum) or 48 hours (urine) before first dose if of child-bearing potential
- Agreement to abstain from heterosexual intercourse or use effective contraception during treatment and for 3 months after last dose
- Blood test results within specified normal limits for kidney, liver, coagulation, bone marrow, and pancreatic enzymes
- Affiliated to a social security system or equivalent
You will not qualify if you...
- Tumor infiltrating lymphocytes (TILs) less than 5%
- Prior systemic therapy or radiotherapy for current breast cancer
- Known allergy or hypersensitivity to durvalumab or its components
- Previous allogeneic stem cell or solid organ transplant
- Live attenuated vaccine within 4 weeks before enrollment or planned during study or within 5 months after last dose
- Treatment with systemic immunostimulatory agents within 4 weeks before enrollment
- Treatment with systemic immunosuppressive medication within 2 weeks before study start, except allowed low-dose or local steroids
- Active or history of autoimmune disease or immune deficiency except treated hypothyroidism or type 1 diabetes on insulin
- History of idiopathic pulmonary fibrosis, organizing pneumonia, or interstitial lung disease
- HIV infection
- Active hepatitis B or C infection (except resolved or controlled cases as defined)
- Active tuberculosis
- Current antiviral treatment for hepatitis B
- Participation in another investigational clinical study within 28 days
- Prior treatment with CD137 agonists or immune checkpoint inhibitors (anti-CTLA-4, anti-PD-1, anti-PD-L1)
- Conditions preventing compliance with study protocol
- Serious uncontrolled diseases increasing risk of treatment complications
- Clinically significant uncontrolled heart disease or recent cardiac events including angina, myocardial infarction, heart failure (NYHA III-IV), cardiomyopathy, LVEF < 50%, certain arrhythmias, uncontrolled hypertension, long QT syndrome, or related risk factors
- Pregnant or breastfeeding females or adults of reproductive potential not using effective birth control
- Patients under legal guardianship or incapable of consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Institut Bergonié
Bordeaux, France
Actively Recruiting
2
Centre Léon Berard
Lyon, France
Actively Recruiting
3
Gustave Roussy
Villejuif, France, 94805
Actively Recruiting
Research Team
J
Joana Mourato RIBEIRO, MD
CONTACT
C
Chloé SERHAL, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here