Study of Denosumab as Adjuvant Treatment for Women With High Risk Early Breast Cancer Receiving Neoadjuvant or Adjuvant Therapy (D-CARE)
- Conditions
- Breast Cancer
- Registration Number
- JPRN-jRCT2080221128
- Lead Sponsor
- DAIICHISANKYO Co.,Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- Female
- Target Recruitment
- 4500
Stage II or III breast cancer at high risk of disease recurrence
-Patient is receiving or is scheduled to receive standard of care adjuvant or neoadjuvant chemotherapy and/or endocrine therapy and/or Human Epidermal Growth Factor Receptor (HER)-2 targeted therapy
-Serum calcium or albumin-adjusted serum calcium >= 2.0 mmol/L (8.0 mg/dL) and <= 2.9 mmol/L (11.5 mg/dL)
-Prior or current evidence of metastatic disease
-History of breast cancer prior to current diagnosis (other than ductal carcinoma in situ [DCIS] or lobular carcinoma in situ [LCIS]
-Osteoporosis requiring treatment
-Active oral, dental or jaw condition
-Non-healed dental or oral surgery
-Use of oral bisphosphonates within the past year
-Prior or current IV bisphosphonate administration
-Subject is pregnant or breast feeding
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method