BridgeMD
New treatment option for Early Small (cT1N0) Triple Negative Breast Cancer
Official title Short-term Pre-OPerative Durvalumab (MEDI 4736) in Early Small Triple Negative Breast Cancer Patients (POP-Durva)
ClinicalTrials.gov ID: NCT05215106
What this study is testing
What is Durvalumab?
Durvalumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for early small (ct1n0) triple negative breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 \ =5%, eligible for a short-term treatment with Durvalumab.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Patient should understand, sign, and date the written informed consent form (including the consent to collect tissue, blood and stool samples, as...
- Female patients aged 18 years or older
- Histologically confirmed untreated invasive carcinoma of the breast (ER \< 10%, PR \< 10%, HER2 negative) as locally determined
- Tumor infiltrating lymphocytes (TILs) ≥ 5% in breast tumor biopsy as locally determined
- Breast cancer clinical TNM stage I (cT1N0 as measured by radiological imaging). Bilateral, multicentric and multifocal tumors are allowed, assuming...
You likely can't join if
- Patients with triple negative breast cancer and TILs \<5%
- Any systemic therapy (e.g, chemotherapy, targeted therapy, immune-therapy) or radiotherapy for current breast cancer disease before study entry
- Known hypersensibility to durvalumab or any of its components
- Patients with prior allogeneic stem cell or solid organ transplantation
- Administration of a live, attenuated vaccine within 4 weeks prior to enrolment or anticipation that such a live, attenuated vaccine will be required...
- Treatment with systemic immunostimulatory agents (including but not limited to interferons or interleukin-2) within 4 weeks or five half-lives of the...
See the full eligibility criteria
Who can join
- 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...
- Female patients aged 18 years or older
- Histologically confirmed untreated invasive carcinoma of the breast (ER \< 10%, PR \< 10%, HER2 negative) as locally determined
- Tumor infiltrating lymphocytes (TILs) ≥ 5% in breast tumor biopsy as locally determined
- Breast cancer clinical TNM stage I (cT1N0 as measured by radiological imaging). Bilateral, multicentric and multifocal tumors are allowed, assuming tumor evaluations and pre- and post-treatment biopsies are performed in...
- No evidence of metastatic disease or confirmed lymph node involvement
- Eastern Cooperative Oncology Group (ECOG) performance status 0/1
- Patients of child-bearing potential are eligible, provided they have a negative serum β-hCG pregnancy test within 2 weeks or urine pregnancy test within 48 hours prior to the first dose of study treatment, and agreement...
- Sexually active women of childbearing potential must agree to use a highly effective method of contraception supplemented by a barrier method, or to abstain from sexual activity during the study and for at least 3...
What rules you out
- Patients with triple negative breast cancer and TILs \<5%
- Any systemic therapy (e.g, chemotherapy, targeted therapy, immune-therapy) or radiotherapy for current breast cancer disease before study entry
- Known hypersensibility to durvalumab or any of its components
- Patients with prior allogeneic stem cell or solid organ transplantation
- Administration of a live, attenuated vaccine within 4 weeks prior to enrolment or anticipation that such a live, attenuated vaccine will be required during the study or within 5 months after the last dose of durvalumab
- Treatment with systemic immunostimulatory agents (including but not limited to interferons or interleukin-2) within 4 weeks or five half-lives of the drug, whichever is shorter, prior to enrolment
- Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate and thalidomide) within 2 weeks prior to initiation of study treatment...
- Patients who received acute, low-dose systemic immunosuppressant medication, or systemic corticosteroids at physiologic doses not to exceed \ \> of prednisone or its equivalent, or a one-time pulse dose of systemic...
- Patients who received mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal...
- Patients who received intranasal, inhaled, topical or local steroid injections (e.g., intra articular injection)
- Active or history of autoimmune disease or immune deficiency, with the exception of history of treated autoimmune-related hypothyroidism and Type 1 diabetes mellitus on insulin regimen
- History of idiopathic pulmonary fibrosis, organizing pneumonia or interstitial lung disease
- History of HIV infection
- Patients with active hepatitis infection (defined as having a positive hepatitis B surface antigen [HBsAg] test at screening) or hepatitis C. Patients with past hepatitis B virus (HBV) infection or resolved HBV...
- Active tuberculosis
- Current treatment with anti-viral therapy for HBV
- Participation in another clinical study with an investigational product during the last 28 days and while on study treatment
- Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including antiCTLA-4, antiPD-1, and antiPD-L1 therapeutic antibodies
- Psychological, familial, sociological or geographical conditions that do not permit compliance with the study protocol
- Serious uncontrolled concomitant disease that would put the patient at high risk of treatment-related complications
- Patient has clinically significant, uncontrolled heart disease and/or recent cardiac events including any of the following:
- History of angina pectoris, coronary artery bypass graft (CABG), symptomatic pericarditis, or myocardial infarction within 12 months prior to the start of study treatment
- History of documented congestive heart failure (New York Heart Association functional classification III-IV)
- Documented cardiomyopathy
- Patient has a Left Ventricular Ejection Fraction (LVEF) \< 50% as determined by Multiple Gated acquisition (MUGA) scan or echocardiogram (ECHO)
- History of any cardiac arrhythmias (e.g., ventricular tachycardia), complete left bundle branch block, high grade AV block (e.g., bifascicular block, Mobitz type II and third degree AV block), supraventricular, nodal...
- Uncontrolled hypertension defined by a Systolic Blood Pressure (SBP) ≥ 160 mmHg and/or Diastolic Blood Pressure (DBP) ≥ 100 mmHg, with or without antihypertensive medication. Initiation or adjustment of antihypertensive...
- Long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome, or any of the following: Risk factors for Torsades de Pointe (TdP) including uncorrected hypokalemia or hypomagnesemia, history...
- Female patients who are pregnant or breastfeeding, or adults of reproductive potential who are not using effective birth control methods. If barrier contraceptives are being used, these must be continued throughout the...
- Patients unwilling to or unable (as assessed by the investigator) to comply with the protocol
- Patients under guardianship or deprived of her liberty by a judicial or administrative decision or incapable of giving its consent.
The study team makes the final eligibility decision.
Where it's taking place
- Bordeaux, France
- Lyon, France
- Villejuif, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bordeaux, France; Lyon, France; Villejuif, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.