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Sponsored by: |
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
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Information provided by: | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
ClinicalTrials.gov Identifier: | NCT00091442 |
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.
Condition | Intervention | Phase |
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Cancer of Breast |
Drug: DOXIL in combination with Docataxel Drug: Docetaxel |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized Controlled Study of Docetaxel Monotherapy or Docetaxel and DOXIL for the Treatment of Advanced Breast Cancer |
Enrollment: | 751 |
Study Start Date: | August 2004 |
Estimated Study Completion Date: | April 2009 |
Arms | Assigned Interventions |
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001: Active Comparator |
Drug: Docetaxel
Docetaxel 75 mg/m2 on Day 1 of every 21-d cycle
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002: Experimental |
Drug: DOXIL in combination with Docataxel
DOXIL/CAELYX (30 mg/m2) followed by docetaxel (60 mg/m2) on Day 1 of every 21-d
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The safety and effectiveness of DOXIL in combination with docataxel 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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
Responsible Party: | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. ( Medical Leader- Oncology ) |
Study ID Numbers: | CR004120, DOXILBCA3001 |
Study First Received: | September 8, 2004 |
Last Updated: | December 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00091442 |
Health Authority: | United States: Food and Drug Administration |
Docetaxel Breast Cancer DOXIL/CAELYX |
Docetaxel Skin Diseases Breast Neoplasms Doxorubicin Breast Diseases |
Neoplasms Neoplasms by Site Antineoplastic Agents |
Therapeutic Uses Antibiotics, Antineoplastic Pharmacologic Actions |