A Study of Docetaxel Monotherapy or DOXIL®/CAELYX® and Docetaxel in Patients With Advanced Breast Cancer - Full Text View

Sponsored by:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:	NCT00091442

Purpose

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
Cancer of Breast	Drug: DOXIL in combination with Docataxel Drug: Docetaxel	Phase III

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Doxorubicin Doxorubicin hydrochloride Docetaxel

U.S. FDA Resources

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

Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:

The primary endpoint of this study was time to progression, the interval between the date of randomization and the date of disease progression or death due to progression. [ Time Frame: The interval between the date of randomization and the date of disease progression or death due to progression. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall survival (the interval between the date of randomization and the subject's deathfrom any cause), and the response rate (the proportion of subjects in the evaluable population who achieved a complete or partial response. [ Time Frame: Overall survival (the interval between the date of randomization and the subject's deathfrom any cause), and the response rate (the proportion of subjects in the evaluable population who achieved a complete or partial response). ] [ Designated as safety issue: No ]

Enrollment:	751
Study Start Date:	August 2004
Estimated Study Completion Date:	April 2009

Arms	Assigned Interventions
001: Active Comparator	Drug: Docetaxel Docetaxel 75 mg/m2 on Day 1 of every 21-d cycle
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

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Females with locally advanced or metastatic breast cancer who received prior anthracycline therapy in the neoadjuvant or adjuvant setting, and had at least a 12-month disease-free interval since the end of their last cytotoxic therapy, were eligible for the study
18 years of age and older
Patients who received prior hormonal therapy, or no more than 1 cytotoxic chemotherapy regimen (anthracyclines, taxanes, or antitubulin agents were not permitted), or both for advanced disease
Patients with normal cardiac function, as evidenced by a normal LVEF

Exclusion Criteria:

More than 1 prior cytotoxic chemotherapy regimen for advanced breast cancer
Treatment of advanced breast cancer with an anthracycline, paclitaxel, docetaxel, vinorelbine, or vinblastine (prior treatment of advanced breast cancer with 1 regimen that included alkylating agents or antimetabolite agents was acceptable)
Less than 2 months since the last dose of trastuzumab
Less than 3 weeks since last dose of tamoxifen or fulvestrant, or less than 1 week since the last dose of other hormonal therapy
Radiation to areas of disease within 30 days before study enrollment
History of New York Heart Association Class II or greater cardiac disease (Appendix 1.1, Attachment 2), or other clinical evidence of congestive heart failure

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00091442

Sponsors and Collaborators

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

Investigators

Study Director:

Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial

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

More Information

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

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Docetaxel
Breast
Cancer
DOXIL/CAELYX

Study placed in the following topic categories:

Docetaxel
Skin Diseases
Breast Neoplasms
Doxorubicin
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Antineoplastic Agents

Therapeutic Uses
Antibiotics, Antineoplastic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009