A phase II study of metronomic oral chemoterapy with Cyclophosphamide plus Capecitabine combined with Trastuzumab in advanced breast cancer - ND

• Conditions: Pre-or post-menopausal women with histologically proven, locally advanced (inoperable) or metastatic breast cancer.

• Registration Number: EUCTR2009-017083-16-IT
• Lead Sponsor: GOIM GRUPPO ONCOLOGICO MERIDIONALE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04-09
• Last Update Posted: 3 September 2012

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. Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques or as >10 mm with spiral CT scan. No previous lines of chemotherapy for advanced disease (primary and/or adjuvant chemotherapy are allowed, as well as any prior endocrine treatment; prior primary and/or adjuvant trastuzumab therapy are allowed, if ended  6 months before. At least 4 weeks must have elapsed since prior chemotherapy or radiation therapy, 6 weeks if the last regimen included mitomycin C). Age >18 years and < 80 years. ECOG performance status <2 (Karnofsky >60% Normal organ and marrow function Ability to understand and the willingness to sign a written informed consent document
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 cerebral or leptomeningeal involvement. Previous or concomitant other malignancy except basal or squamous cell carcinoma of the skin or adequately treated in situ carcinoma of the cervix. History of allergic reactions attributed to compounds of similar chemical or biologic composition to trastuzumab or other agents used in the study Seriuos cardiac illness -Poorly controlled hypertension Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, renal failure, or psychiatric illness/social situations that would limit compliance with study requirements.

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 in terms of overall clinical benefit, defined as the objective response rate plus the rate of stable disease lasting longer than 24 weeks.;Secondary Objective: To describe the toxicity and to estimate the time to disease progression and the overall survival, as well as to evaluate the impact of treatment on tumor angiogenesis, assessing the change in levels of circulating endothelial cells.;Primary end point(s): To assess the activity in terms of overall clinical benefit, defined as the objective response rate plus the rate of stable disease lasting longer than 24 weeks.