A phase II study of primary chemotherapy with pegylated liposomal doxorubicin (Caelyx), Cisplatin, and Fluorouracil (CCF) followed by metronomic Capecitabine, Cyclophosphamide and Sorafenib (CCS) in early and locally advanced, ?triple negative? breast cancer - ND

Conditions: Patients with histologically proven locally advanced primary breast cancer (cT2-T3-T4 a-d, N0-3c, M0) or patients with histologically proven local recurrence after breast conserving surgery (rT1-T4, N0-3c, M0, triple negative (absence of ER, PgR and c-erbB2 expression)
MedDRA version: 9.1Level: LLTClassification code 10057654Term: Breast cancer female

Registration Number: EUCTR2007-006306-25-IT

Lead Sponsor: ISTITUTO EUROPEO DI ONCOLOGIA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: Not specified

Inclusion Criteria

Patients with histologically proven locally advanced primary breast cancer (cT2-T3-T4 a-d, N0-3c, M0) or patients with histologically proven local recurrence after breast conserving surgery (rT1-T4, N0-3c, M0)
Patients with triple negative breast cancer (absence of ER, PgR and c-erbB2 expression on tumor cells defined according to EIO guidelines)
Patients must be suitable for local treatment (surgery) in a multidisciplinary program
Bilateral breast cancers are eligible
Women aged >18 years
Performance status 0-1 (ECOG scale)
Life expectancy of at least 12 wee
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

Presence of tumor expression of ER and PgR
Presence of tumor HER2/neu overexpression or amplification
Patients with distant metastatic disease
Patients with other non-malignant uncontrolled systemic diseases that would preclude trial entry in the opinion of the investigator. Specifically not eligible are the following:

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The main objective is to assess the activity in terms of pathological complete remission rate.;Secondary Objective: toxicity, the time to disease progression and the overall survival;Primary end point(s): pathological complete remissions

Secondary Outcome Measures