Phase 3
Completed N=751
A Study of Docetaxel Monotherapy or DOXIL and Docetaxel in Patients With Advanced Breast Cancer
Source: ClinicalTrials.gov NCT00091442 ↗Enrolled (actual)
751
Serious AEs
17.1%
Results posted
Oct 2012
Primary outcomePrimary: Time to Progression — 7.0; 9.8 Months — p=<0.0001
Summary
The purpose of the study is to evaluate whether the time to progression for the DOXIL and docetaxel combination therapy group was superior to that of the group treated with docetaxel monotherapy in participants with advanced breast cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Progression |
7.0; 9.8 | <0.0001 sig |
| SECONDARY Overall Survival |
20.7; 20.4 | 0.5988 |
| SECONDARY Response Rate: Number of Participants in the Evaluable Population Who Achieved a Complete Response (CR) or Partial Response (PR) |
95; 129 | 0.0085 sig |
Eligibility 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
- Participants 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
- Participants with normal cardiac function, as evidenced by a normal left ventricular ejection fraction
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 or other clinical evidence of congestive heart failure
Data sourced from ClinicalTrials.gov (NCT00091442). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.