Metronomic Capecitabine plus Docetaxel as first line treatment for metastatic breast cancer patients: a phase II trial - ND

• Conditions: Metastatic breast cancer; MedDRA version: 9.1Level: LLTClassification code 10055113Term: Breast cancer metastatic

• Registration Number: EUCTR2009-009937-14-IT
• Lead Sponsor: ISTITUTO EUROPEO DI ONCOLOGIA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04-01
• 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 (female) with documented advanced/metastatic breast cancer without HER-2/neu over expression ( IHC 3+ or FISH positive)
Patients may not have received a previous chemotherapy regimen for metastatic breast cancer
Patients may have received previous hormonal treatment for endocrine responsive metastatic disease.
Patients may have received chemotherapy with taxanes as adjuvant treatment provided that metastatic disease occurred at least 6 months after the completion of adjuvant chemotherapy.
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 who have received:
-1 or more regimens of chemotherapy for metastatic disease;
-taxanes in the adjuvant setting < 6 months from study entry
Patients with HER2 overexpressing metastatic breast cancer
Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel
Presence of known clinical brain or meningeal involvement.
Any other cardiac condition, which in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient;
Concomitant treatment with other anticancer (chemotherapy or endocrine therapy) drugs.
Concomitant treatment with any other experimental drug.

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 overall response rate, according to RECIST criteria<br>To determine the overall survival (OS);Secondary Objective: To assess time to progression disease (TTP) To determine the duration of response (DR).To assess toxicity (adverse events) and QoL To investigate the predictive and prognostic value of serum CTCs levels on clinical outcome;Primary end point(s): To assess the overall response rate, according to RECIST criteria<br>To determine the overall survival (OS)