Local advanced breast cancer resectable, neoadjuvant setting MedDRA version: 14.1 Level: LLT Classification code 10072740 Term: Locally advanced breast cancer System Organ Class: 100000004864
Conditions
Interventions
Trade Name: MYOCET
Pharmaceutical Form: Powder and solvent for dispersion for injection
INN or Proposed INN: DOXORUBICIN
CAS Number: 23214-92-8
Concentration unit: mg milligram(s)
Concentration type:
Sponsors
S.I.C.O.G. ONLUS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: HER2-positive (immunohistochemistry (IHC 3 +) or amplification detected by fluorescence in situ hybridization [FISH +]) - Age >18 - Performance status ECOG 0-1 - Life expectancy> 3 months - Neutrophils = 1.5 x 10 9 / L and PLatelets = 100 x 10 9 /L - Total bilirubin = 1.5 times upper normal limit (UNL) of the Centre - ASAT (GOT) and / or ALT (GPT) = 2.5 UNL - Alkaline phosphatase = 5 UNL (unless they are bones metastases in the absence of any liver disease. Patients with AST and / or ALT> 1.5 x UNL associated with alkaline phosphatase > 2.5 xUNL are not eligible in the study - Creatinine within normal institutional limit - Ventricular ejection fraction (LVEF) = 55% (assessed by MUGA scan or ultrasound - only one method should be used for each patient) -Written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 41 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 41
Exclusion criteria
Exclusion criteria: - absence of Written informed consent - Previous chemotherapy - History of cancer in the previous 10 years (except skin cancer,non-melanoma,cervical carcinoma in situ excised) - Other serious illnesses - Congestive heart failure or angina pectoris even if controlled, previous history of myocardial infarction, uncontrolled hypertension, or arrhythmia. - History of neurological or psychiatric disorders including dementia and epilepsy. - Active Infection - Treatment with other experimental drugs - Geographical inaccessibility for treatment and follow-up - Women who are pregnant or lactating
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): No secondary end point has been fixed in this protocol ;Timepoint(s) of evaluation of this end point: No secondary end point has been fixed in this protocol | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Patological Complete Response Rate, considered as a total absence of primary infiltrating tumour on breast and nodes;Secondary Objective: Clinical Response rate; Radiological response rate; Conservative surgery rate; Evaluation of cardiac toxicity; ;Primary end point(s): The sample size is calculated according to the two-stage (Minimax design) Simon method. Taking into account that the primary endpoint, the rate of pRC, is 40% for the optimal regimes (phase II studies unconfirmed) while the conventional schemes is 20%, with a difference p1-p0 = 20% between chemotherapy treatment "standard" (p0 = 20%) and "trial treatment" (p1 = 40%), and by fixing the probability of error a = 0.05 and ß = 0.20, the number of patients to be enrolled is a total of 37 (increased of 10% for predictable dropouts). ;Timepoint(s) of evaluation of this end point: The study will be stopped if less than 3 responses will be observed in the first 19 patients, otherwise will continue to enroll until a total of 41 patients. | — |
Countries
Italy
Contacts
Public ContactData Management
S.I.C.O.G. ONLUS
Outcome results
None listed