A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase 3 Study of Denosumab as Adjuvant Treatment for Women with Early-Stage Breast Cancer at High Risk of Recurrence (D-CARE)

What is the purpose of this trial?

This is an international, phase 3, randomized, double-blind, placebo-controlled study in women with early-stage (stage II or III) breast cancer at high risk of disease recurrence.

 

Approximately 4,500 subjects will be randomized in a 1:1 ratio to receive denosumab 120 mg or matching placebo subcutaneously (SC) every 4 weeks (Q4W; ± 7 days) for approximately 6 months followed by denosumab 120 mg or matching placebo SC every 3 months (Q3M; i.e. every 12 weeks ± 14 days) for 4½ years (approximately 54 months), for a total treatment duration of 5 years (approximately 60 months). All subjects will be required to receive vitamin D and calcium supplementation at standard doses (at least 500 mg calcium and at least 400 IU of vitamin D), unless documented hypercalcemia develops on study. Subjects who develop bone metastasis will permanently discontinue treatment, complete the End of Treatment Phase (EOTP) visit, and enter follow-up upon documented evidence (per central imaging analysis or biopsy).

After completing the treatment phase of the study, subjects will be followed by clinic visit or telephone contact approximately monthly for 6 months to assess clinical outcomes, approximately every 3 months thereafter to assess disease recurrence status and survival (until documented evidence of bone metastasis), and approximately every 6 months (± 1 month) thereafter to assess survival, for up to 10 years (120 months) from the date of randomization

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Participation Guidelines

Click here for detailed information about who can participate in this trial.

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Sponsor:

Dates:

2/7/2012

Last Updated:

Study HIC#:

1105008443

Clinicaltrials.gov ID: Yale1152569