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-ES
- Lead Sponsor
- J&JPRD, a division of Janssen-Cilag
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 0
- 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
- 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
- Secondary Outcome Measures
Name Time Method