Clinical Trial Result Information

Protocol number
ML17771

Title of Study
An open-label, randomized, phase III study of capecitabine in combination with docetaxel vs capecitabine followed by docetaxel as first-line treatment for metastatic breast cancer

Sponsor
Roche Laboratories Inc.

Company division
Pharmaceutical

Product name
Xeloda

Generic name
capecitabine

Therapeutic area
Breast Cancer

Clinical study summary
This trial was prematurely terminated, due to insufficient enrollment. Clinical trial results, other than key safety statements, have not been posted, due to insufficient data.

Study center(s)
1 center in the United States.

Phase of development
IV

Objectives
Primary: To evaluate and compare the time to progression of the combination of Xeloda (825 mg/m2 twice daily Days 1-14) and docetaxel (75 mg/m2 IV Day 1 q3w) to that of Xeloda (1000 mg/m2 twice daily Days 1-14 q3w until progressive disease followed sequentially by docetaxel (75 mg/m2 IV Day 1 q3w).

Secondary: To evaluate and compare the efficacy and safety profiles in each treatment group.

Methodology
After a screening assessment and physical examinations, patients were to be randomized to 1 of 2 arms in a 1:1 ratio. Assessments of tumor response were to be performed every 6 weeks prior to the start of the next cycle and at the time of coming off treatment regardless of the reason. Only serious adverse events were to be reported during the poststudy treatment phase, and for 28 days after the last intake of study drug in the poststudy treatment phase. Overall survival and additional cancer therapies were to be documented for all patients every 3 months until death.

Number of patients (planned/analyzed)
400 planned; 1 enrolled in Arm B.

Diagnosis and main criteria for inclusion
Female patients ≥18 years of age with metastatic breast cancer with relapse after adjuvant pretreatment with chemotherapy (including Herceptin for HER2-positive patients) and/or hormonal treatment.

Test product, dose and mode of administration or test procedure
Capecitabine, 825 or 1000 mg/m2 BID orally. Docetaxel, 75 mg/m2 IV.

Duration of treatment
Up to approximately 10 months (planned).

Reference therapy, dose and mode of administration or reference procedure
None

Criteria for evaluation (efficacy, safety)
Efficacy: Primary: Time to progression or death.
Secondary: (1) Overall response rate; (2) Time to response; (3) Duration of response; (4) Time to treatment failure; (5) Overall survival.

Safety: Adverse events; laboratory tests; premature withdrawals; vital signs

Statistical methods
Safety data were summarized for the single patient enrolled in this study.

Summary (efficacy, safety, other results)
Only 1 patient was enrolled in this study. She was hospitalized after 10 days of treatment, having been found unresponsive; this serious adverse event was considered unrelated to study treatment. She subsequently died of breast cancer, considered to be unrelated to study treatment.

Conclusions
No conclusions can be drawn from this study, due to its early termination.

Date of report
10/26/2005