Phase II study of preoperative bevacizumab plus weekly paclitaxel, carboplatin and metronomic cyclophosphamide ? trastuzumab and endocrine therapy for inflammatory breast cancer - ND

• Conditions: Inflammatory breast cancer; MedDRA version: 9.1Level: PTClassification code 10021980

• Registration Number: EUCTR2009-016453-17-IT
• Lead Sponsor: ISTITUTO EUROPEO DI ONCOLOGIA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12-14
• 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 inflammatory primary breast cancer cT4d, or rT4d, N0-3c, any ER e PgR, HER2 positive or negative
Women aged 1870 years
ER, PgR and c-erbB-2 expression defined according to Pathology Division IEO
No evidence of distant metastatic disease
No previous preoperative treatment for breast cancer
PS=0-2 (ECOG)
LVEF ≥ 55% with Echocardiography or MUGA Scan
Negative pregnancy test
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

Non inflammatory breast cancer
Patients with metastatic disease
Patients with other non-malignant uncontrolled systemic diseases that would preclude trial entry in the opinion of the investigator.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate the efficacy, on the rate of pathological complete remission (pCR), of the combination of weekly carboplatin and paclitaxel in combination with bevacizumab, oral cyclophosphamide plus trastuzumab in patients with HER2 positive tumors and endocrine therapy in endocrine responsive tumors in patients with primary inflammatory breast cancer (IBC) or recurrent IBC candidate to locoregional definitive treatment.;Secondary Objective: To assess the safety and the tolerability of the combination;Primary end point(s): The rate of pCR (pathological complete remission) defined as the complete disappearance of invasive tumor both in the breast and in the axilla; <br>the objective response rate according to the RECIST criteria when applicable and clinically evaluable skin criteria including erythema, edema, peau dorange;