PHASE II TRIAL OF PRIMARY CHEMOTHERAPY WITH TRASTUZUMAB IN COMBINATION WITH DOCETAXEL FOLLOWED BY EPIRUBICIN-CYCLOPHOSPHAMIDE IN PATIENTS WITH HER2-OVEREXPRESSING OPERABLE BREAST CANCER - DECT

• Conditions: Primary chemotherapy in Her2-overexpressing operable breast cancer patient; MedDRA version: 6.1Level: PTClassification code 10057654

• Registration Number: EUCTR2007-003466-18-IT
• Lead Sponsor: ISTITUTI FISIOTERAPICI OSPITALIERI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07-06
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

● Histologically proven HER2-positive breast cancer

● cT2-T3 N0-N2 breast cancer

● ECOG PS status <= 1

● Age 18-75 years

● Normal cardiac function confirmed by ECG and LVEF

● Normal hemathologic, epatic and renal function

● Complete staging within 45 days prior to registration, with no evidence of metastatic disease

● Patients must be accessible for treatment and follow-up

● Negative pregnancy test (urine or serum)

● Patient 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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Prior systemic therapy for breast cancer

Prior radiation therapy for breast cancer

Evidence of metastatic or locally advanced disease

Pre-existing neuropathy grade >= 2 by NCI criteria

Cardiac diseases: previous myocardial infarction or angina pectoris, history of congestive heart failure, grade 3-4 cardiac arrhythmia, clinically significant valvular heart disease, poorly controlled hypertension

Psychiatric disorders

Active uncontrolled infection

Active peptic ulcer, unstable diabetes mellitus

Past or current history of other neoplasm except for curatively treated non-melanoma skin cancer, in situ carcinoma of the cervix

Concurrent use of other experimental drugs

Male patients

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the percentage of pCR after treatment at definite surgery;Secondary Objective: To evaluate toxicity and cardiotoxicity<br><br>To evaluate pathological and molecular markers for predicting efficacy and cardiotoxicity;Primary end point(s): Complete pathological response defined as no residual invasive cancer