-
Titre abrégé
DECRESCENDO
-
NCT
-
N° Eudract
2020-002918-41
-
Phase de l'essai
- Phase II
-
Type de promoteur
Académique / Institutionnel
-
Nom du promoteur
Institut Jules Bordet
-
1) Male or female. 2) Age e"18 years old. 3) Eastern Cooperative Oncology Group (ECOG) performance status d"1. (Appendix 1). 4) Subjects whose tumour measures e"15 mm and d"50 mm, according to clinical staging performed with imaging exams (either mammography, ultrasound or breast magnetic resonance imaging [MRI]). 5) Must have histologically confirmed diagnosis of HER2-positive and ER-negative/PR-negative breast cancer (analysis performed by the local laboratory). 6) Subjects with multifocal or multicentric invasive disease are eligible as long as all the lesions can be characterised and are confirmed to be HER2-positive and ER and PR negative. 7) Node-negative disease (N0): no axillary lymph nodes identifiable at ultrasound, or in case of suspect axillary lymph nodes are identified, fine-needle aspiration or core biopsy must be carried out to confirm that axillary status is negative. Axillary micrometastases (i.e., if the greatest diameter of the nodal metastasis in a sentinel node is 0.2 mm or less) are not allowed. 8) Serum pregnancy test (for women of childbearing potential) negative within 7 days prior to treatment start. 9) Women of childbearing potential must agree to use 1 highly effective non-hormonal contraceptive method with a failure rate of less than 1% per year 10) Adequate bone marrow and coagulation functions as defined below: - Absolute neutrophil count e"1500 /¼L or 1.5x109/L - Haemoglobin e"9 g/dL (blood transfusions to reach these levels of haemoglobin are allowed) - Platelets e"100,000/¼L or 100x109/L - International normalized ratio (INR) and activated partial thromboplastin time (aPTT) d" 1.5 ×ULN 11) Adequate liver function as defined below: - Serum total bilirubin d"1.5 x ULN. In case of known Gilbert s syndrome d"3xUNL is allowed - AST (SGOT) and ALT (SGPT) d"2.5 x ULN - Alkaline phosphatase d"2.5 x ULN 12) Adequate renal function as defined below: Creatinine d"1.5 x UNL or creatinine clearance >60 mL/min/1.73 m2 13) Completion of all necessary screening procedures within 28 days prior to enrolment. 14) Adequate cardiac function, defined as a left ventricular ejection fraction e"55% estimated by echocardiogram (ECHO) or multiple-gated acquisition scintigraphy (MUGA). 15) Availability of a pre-treatment tumour biopsy sample as specified in the protocol 16) Signed Informed Consent form (ICF) obtained prior to any study related procedure. 17) Subject is willing and able to comply with the protocol for the duration of the study including treatment and scheduled visits and examinations. 18) Affiliated to the French Social Security System
-
1) Pregnant and/or lactating women. 2) Bilateral invasive breast cancer. 3) Evidence of metastatic breast cancer: all subjects must have had a CT/MRI scan of the thorax/abdomen/pelvis to rule out metastatic breast cancer prior to enrolment. FDG/PET-CT can be used as an alternative to replace all the exams above. A screening bone scan must have been done if ALP and/or corrected calcium levels were above the institutional upper limits at screening (if PET/CT was used as an alternative imaging exam, a bone scan and/or CT/MRI is not required). 4) Subject with a significant medical, neuro-psychiatric, or surgical condition, currently uncontrolled by treatment, which, in the investigator s opinion, may interfere with completion of the study. 5) Previous exposure to any anti-HER2 treatment. 6) Concomitant exposure to any investigational products as part of a clinical trial within 30 days prior to enrolment. 7) Subject with second primary malignancies diagnosed d" 5 years before enrolment in the study. Exceptions are: adequately treated non-melanoma skin cancer, in situ cancer of the cervix, ductal carcinoma in situ of the breast, and any other solid or haematological tumour diagnosed > 5 years before enrolment and for which no chemotherapy and no systemic treatment were necessary, with no evidence of disease recurrence. 8) Resting electrocardiogram (ECG) with QTc >470 msec detected on at 2 or more time points within a 24-hour period, or family history of long QT syndrome. 9) Serious cardiac illness or medical conditions 10) History of ventricular dysrhythmias or risk factors for ventricular dysrhythmias, such as structural heart disease (e.g., severe LVSD, left ventricular hypertrophy), coronary heart disease (symptomatic or with ischemia demonstrated by diagnostic testing), clinically significant electrolyte abnormalities (e.g., hypokalemia, hypomagnesemia, hypocalcemia), or family history of sudden unexplained death or long QT syndrome. 11) Peripheral neuropathy (CTCAE version 5) grade e"2. 12) Major surgery within 14 days prior to enrolment. 13) Subject with HIV, Hepatitis B or Hepatitis C infection documented by serology, except for those subjects with a previous exposure to Hepatitis B who developed an effective immune response (HBSAg-negative and anti-HBS-positive). 14) Previous allogeneic bone marrow transplant. 15) Known prior severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (CTCAE grade e"3). 16) Subjects who received live attenuated vaccines within 14 days before enrolment 17) Vulnerable persons according to the article L.1121-6 of the CSP, adults who are the subject of a measure of legal protection or unable to express their consent according to article L.1121-8 of the CSP.
-
Nom du centre
HCL - CH Lyon Sud
Lyon -
Contact Investigateur
-
Nom
Julien PERON
-
Contact ARC/TER/IRC
-
Nom
Audrey GELOT
-
Email
-
Nom du centre
Centre Léon Bérard
Lyon -
Contact Investigateur
-
Nom
Dr. Thomas BACHELOT
-
Autre contact
Pr RAY-COQUARD Isabelle ; Dr TREDAN Olivier ; Dr HEUDEL Pierre Etienne ; Dr DUFRESNE Armelle ; Dr CARBONNAUX Mélodie ; Dr VANACKER Hélène ; Dr LAURENT Marie ; Dr MEDJEBAR Soleine ; Dr RUSTE Valentine ; Dr GILLE Romane ; Dr TOUSSAINT Philippe ; Dr BONNET Elise ;
-
Contact ARC/TER/IRC
-
Nom
Mme Lucie DUBY
-
Autre contact
Mme MALICA Corinne ;
-
Nom du centre
CHU Grenoble Alpes - Hôpital Nord
-
Contact Investigateur
-
Nom
MOUSSEAU Mireille
-
Contact ARC/TER/IRC
-
Nom
Amandine RAMON