A Randomized Controlled Study of Docetaxel Monotherapy or Docetaxel and DOXIL for the Treatment of Advanced Breast Cancer - DOXIL BCA

• Conditions: Breast cancer

• Registration Number: EUCTR2004-000617-19-EE
• Lead Sponsor: Janssen-Cilag International N.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12-01
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 720

Inclusion Criteria

- Female
- Age 18 years or older
- Advanced breast cancer (Stage IIIb, not amenable to surgical treatment or Stage IV), for which there is histologic or cytologic proof of malignancy
- Presence of measurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST) provided in Attachment 4, RECIST Criteria
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) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- More than 1 prior cytotoxic chemotherapy regimen for advanced breast cancer (this does not include treatment given in the neoadjuvant or adjuvant setting)
- Treatment of advanced breast cancer with an anthracycline, paclitaxel, docetaxel, vinorelbine, or vinblastine (prior treatment of advanced breast cancer with 1 regimen that includes alkylating agents or antimetabolite agents is acceptable)

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this study is to evaluate whether the overall survival for the DOXIL/CAELYX and docetaxel treatment group is superior to that of the group treated with docetaxel monotherapy;Secondary Objective: Secondary objectives are to compare the objective response (complete response plus partial response) rate, time to progression, and safety profile between the treatment groups, and to explore the impact of treatment on quality of life experienced by the subjects, by using the Functional Assessment of Cancer Therapy-Breast(FACT-B). Pharmacogenomic studies will evaluate the relationship between genes that might increase the likelihood of anthracycline-induced cardiotoxicity and clinical events observed during treatment on the study.;Primary end point(s): Primary End point<br>Overall survival: the interval between the date of randomization and the subject's death from any cause.