A Study of Docetaxel Monotherapy or DOXIL/CAELYX and Docetaxel in Patients With Advanced Breast Cancer

2014-08-27 03:54:04 | BioPortfolio


This was a randomized, active control, parallel-group, open-label, multicenter study designed to determine if women with locally advanced or metastatic breast cancer, who were previously treated with prior anthracycline therapy in the neoadjuvant or adjuvant setting, and who also had a disease-free interval of at least 12 months since the end of their last cytotoxic therapy, would benefit from the addition of DOXIL/CAELYX to docetaxel therapy.


The safety and effectiveness of DOXIL in combination with docetaxel will be compared to treatment with docetaxel alone (monotherapy). The primary objective of this study was to evaluate whether the time to progression for the DOXIL/CAELYX and docetaxel combination therapy group was superior to that of the group treated with docetaxel monotherapy. Secondary objectives were to compare the treatment groups for overall survival, response rate (complete plus partial responses), the effect of treatment on patient-reported outcomes using the Functional Assessment of Cancer Therapy-Breast (FACT-B) instrument, and the safety profile. Patients randomly assigned in a 1:1 allocation to treatment will receive either docetaxel (75 mg/m2 on Day 1 of every 21-day cycle) or DOXIL/CAELYX (30 mg/m2) followed by docetaxel (60 mg/m2) on Day 1 of every 21-day cycle.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Cancer of Breast


Docetaxel, DOXIL in combination with Docataxel




Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:54:04-0400

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