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Study of Denosumab as Adjuvant Treatment for Women With High Risk Early Breast Cancer Receiving Neoadjuvant or Adjuvant Therapy (D-CARE)

Phase 3
Completed
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
Inclusion Criteria

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)

Exclusion Criteria

-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
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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