?Fase II study with epirubicin, cisplatin and infusional fluorouracil (ECF) followed by weekly paclitaxel plus metronomic cyclophosphamide ? trastuzumab as preoperative treatment of locally advanced ER and PgR negative breast cancer?. - ND

• Conditions: ocally advanced breast cancer; MedDRA version: 12.0Level: LLTClassification code 10057654Term: Breast cancer female

• Registration Number: EUCTR2009-012048-18-IT
• Lead Sponsor: ISTITUTO EUROPEO DI ONCOLOGIA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07-24
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

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

Inclusion Criteria

Patients with histologically proven primary breast cancer (T2-T3 T4 a-d, N0-3, M0) T2-T4 a-d ER and PgR < 10%, HER2 positive/negative breast cancer Women aged 18?70 years No treatment with previous chemotherapy / endocrine therapy Performance status 0-2 (ECOG scale) No evidence of distant metastatic disease LVEF &#8805; 55% at basal echocardiography or MUGA scan
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

Patients with ER and /or PgR &#8805; 10% HER2 negative or positive T-2-4 a-d tumors Patients with other non-malignant uncontrolled systemic diseases that would preclude trial entry in the opinion of the investigator. Specifically not eligible are patients with uncontrolled active infection, chronic infection such as active HBV or HCV Patients with distant metastatic disease Patients with a history of any prior ipsilateral or contralateral invasive breast cancer.

Study & Design

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