Untreated operable small triple negative breast cancer MedDRA version: 20.0 Level: PT Classification code 10075566 Term: Triple negative breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: IMFINZI
Product Code: MEDI4736
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: DURVALUMAB
Other descriptive name: MEDI4736
Concentration unit: mg/ml milligram(s)/millilitre
Sponsors
Gustave Roussy
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 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 study visits and procedures as per protocol. 2. Female patients aged 18 years or older 3. Histologically confirmed untreated invasive carcinoma of the breast (ER 9 g/dL, Serum albumin > 2.5 g/dL • Fasting Serum amylase = 2 x ULN • Fasting Serum lipase =
Exclusion criteria
Exclusion criteria: 1.Patients non-candidate for upfront breast surgery or candidate for neoadjuvant chemotherapy 2.Any systemic therapy (...) or radiotherapy for current breast cancer disease before study entry 3.Known hypersensibility to durvalumab or any of its components 4.Patients with prior allogeneic stem cell or solid organ transplantation 5.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 6.Treatment with systemic immunostimulatory agents (...) within 4 weeks or five half-lives of the drug, whichever is shorter, prior to enrolment 7.Treatment with systemic immunosuppressive medication (...) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment, with the following exceptions: • 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 immunosuppressant medication (...) are eligible for the study • Patients who received mineralocorticoids (e.g., fludrocortisone), corticosteroids for COPD or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency are eligible for the study • Patients who received intranasal, inhaled, topical or local steroid injections (e.g., intra articular injection) 8.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 9.History of idiopathic pulmonary fibrosis, organizing pneumonia or interstitial lung disease 10.History of HIV infection 11.Patients with active hepatitis infection (defined as having a positive HBsAg test at screening) or hepatitis C. Patients with past HBV infection or resolved HBV infection (defined as having a negative HBsAg test and a positive to anti-HBc antibody test) are eligible. Patients positive for HCV antibody are eligible only if PCR is negative for HCV RNA 12.Active tuberculosis 13.Current treatment with anti-viral therapy for HBV 14. Participation in another clinical study with an investigational product during the last 28 days and while on study treatment 15.Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including antiCTLA-4, antiPD-1, and antiPD-L1 therapeutic antibodies 16.Psychological, familial, sociological or geographical conditions that do not permit compliance with the study protocol 17.Serious uncontrolled concomitant disease that would put the patient at high risk of treatment-related complications 18.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, h
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the effect of 6 weeks of pre-operatory durvalumab in pCR in patients with early small (cT1N0) triple negative breast cancer;Secondary Objective: •To assess if preoperative treatment with durvalumab is associated with decreased tumor size as determined by RECIST 1.1 criteria by breast US •To evaluate the safety of the administration of 6 weeks of durvalumab ;Primary end point(s): The primary endpoint is pCR rate after 6 weeks of durvalumab, defined as the absence of invasive disease in the breast and negative axillary nodes (ypT0/yTis ypN0);Timepoint(s) of evaluation of this end point: See above | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Objective response rate by ultrasound after 6 weeks of durvalumab • Incidence, nature and severity of Adverse Events graded according to NCI-CTCAE v5.0 collected during durvalumab treatment and up to 4 weeks post-surgery ;Timepoint(s) of evaluation of this end point: See above | — |
Countries
France
Contacts
Public ContactSponsor Project Manager
Gustave Roussy
Outcome results
None listed