Phase II study evaluating the combination of liposomal doxorubicin pluscyclophosphamide with trastuzumab followed by docetaxel plustrastuzumab as therapy to be performed before surgery (neoadjuvantchemotherapy) for patients with breast cancer more than 2 cm in size and possible involvement of the lymph nodes adjacent and with the receptor HER2 positive.

Phase 1

Conditions: ocal advanced breast cancer resectable, neoadjuvant setting
MedDRA version: 14.1Level: LLTClassification code 10072740Term: Locally advanced breast cancerSystem Organ Class: 100000004864
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2013-002684-25-IT

Lead Sponsor: S.I.C.O.G. ONLUS

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Female

Target Recruitment: 41

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

-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