A phase II study of metronomic oral chemotherapy with cyclophosphamide plus capecitabine combined with bevacizumab and erlotinib (BEXE), plus trastuzumab in HER2/neu positive tumors (BEXET), in advanced breast cancer

• Conditions: advanced or metastatic breast cancer; MedDRA version: 14.1Level: PTClassification code 10006187Term: Breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2007-006025-27-IT
• Lead Sponsor: ISTITUTO EUROPEO DI ONCOLOGIA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02-20
• Last Update Posted: 7 January 2013

Recruitment & Eligibility

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

Inclusion Criteria

Pre- or post-menopausal women with histologically proven, locally advanced
(inoperable) or metastatic breast carcinoma.
Immunohistochemical receptor status at the last biopsy available:
ER and PgR absent (0% of the cells) or
ER or PgR Absent or
ER and PgR ≤ 50% of the cells

Measurable disease

Age >18 years

Life expectancy of greater than 6 months.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
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

Previous treatment with bevacizumab, EGFR inhibitors or metronomic cyclophosphamide + capecitabine.

Immunohistochemical receptor status at the last biopsy available:
ER and PgR≥50%

Presence of cerebral or leptomeningeal involvement.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: to assess the activity of the proposed regimen;Secondary Objective: ?To describe the toxicity of the regimen.<br>?To estimate the time to disease progression and the overall survival and rate of stable disease lasting longer than 24 weeks;Primary end point(s): overall clinical benefit, defined as the objective response rate plus the rate of stable disease lasting longer than 9 weeks.