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A Randomized Controlled Study of Docetaxel Monotherapy or DOXIL/CAELYX and Docetaxel for the Treatment of Advanced Breast Cancer

Unique Dataset ID2004-000617-19
SponsorJohnson & Johnson Pharmaceutical Research & Development, L.L.C.Data ProviderJanssenTotal Study Enrolled Patients850Comparator (Control) Arm Enrolled Patients373RandomizationYes
Study PhaseClinical Study Phase IIIBlinding MethodOpen Label StudyType(s) of dataOnly comparator arm dataIntervention TypeDrugDataset TypeOther

Clinical Trial Title

A Randomized Controlled Study of Docetaxel Monotherapy or DOXIL/CAELYX and Docetaxel for the Treatment of Advanced Breast Cancer

Trial Summary and Conditions

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 anthracyclines 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. Prior to random assignment to treatment, subjects were assigned to strata according to whether they received prior cytotoxic chemotherapy for advanced disease (yes, no) and their Eastern Cooperative Oncology Group (ECOG) Performance Status scores (0, 1, 2) at baseline. Subjects were then randomly assigned in a 1:1 allocation within each stratum to 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. Treatment was to continue until disease progression or the occurrence of unacceptable treatment-related toxicity. In the absence of progression and unacceptable treatment-related toxicity, treatment was to continue for at least 2 cycles after a complete response was confirmed. For subjects with a partial response or stable disease, treatment could continue after a maximum objective response was obtained unless the subject experienced unacceptable treatment-related toxicity. Disease assessments were to occur at the end of Cycles 2, 4, 6, and 8, and then every 3 cycles until 52 weeks after the start of the study medication, and then every 4 cycles until disease progression. For subjects who discontinued study medication prior to disease progression, disease assessments were to occur every 6 weeks for the first 24 weeks after the start of study medication, and then every 9 weeks from 25 weeks to 52 weeks after the start of study medication, and then every 12 weeks until disease progression.

Data Summary

Control arm (Docetaxel) data files include raw data on safety, efficacy, demographic, and baseline disease characteristics

Study Objectives

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. Pharmacogenomic studies (e.g., hemochromatosis gene [HFE] genotypes) were planned to evaluate the relationship between genes that might increase the likelihood of anthracyclines-induced cardiotoxicity and clinical events observed during the study treatment.

Outcome Measures

The primary endpoint of this study was time to progression, defined as the interval between the date of randomization and the date of disease progression by independent review or death due to progression, whichever occurred first. For subjects who were progression free at the time of data cutoff, data was censored at the time of their last tumor assessment. For subjects with no post baseline disease assessment, data was censored on Day 1. The key secondary endpoints of this study were overall survival and response rate (determined by independent review). Overall survival was defined as the interval between the date of randomization and the subject's date of death from any cause. If the date of death was unknown, data was censored at the date that the subject was last known to have been alive. Response rate was defined as the proportion of subjects in the evaluable population who achieved a complete or partial response according to the RECIST criteria.

Available Downloads:

To gain access to the data and analytic tools click here.

PROTOCOL: DOXIL-BCA-3001-Protocol.pdf