AMG 162: 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)

Summary:
The purpose of this research study is to evaluate how safe and effective denosumab is, compared with placebo, at delaying the time it takes for cancer to spread to the bones in subjects with early-stage breast cancer at high risk of recurrence.  Denosumab is approved to treat osteoporosis (softening of the bones that may lead to fracture), but researchers would like to know how it will affect breast cancer.

Eligibility and Treatment Plan:

1. Women of at least 18 years of age.
2. Subjects must be receiving or be scheduled to receive standard of care adjuvant orneoadjuvant chemotherapy and/or endocrine therapy and/or HER-2 targeted therapy.

3. Histologically confirmed, AJCC stage II or III breast cancer.
4. High risk of breast cancer recurrence.

Please call the Continuum Cancer Research Program: 212-844-6286 for more information.