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

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)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221128

Enrollment

4500

Registered

2010-06-11

Start date

2010-06-02

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Interventions

investigational material(s) Generic name etc : Denosumab INN of investigational material : denosumab Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigationa

Eligibility

Sex/Gender

Female

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
efficacy Bone metastasis-free survival	—

Secondary

Measure	Time frame
efficacy Disease-free survival Overall survival Distant recurrence-free survival Safety and tolerability of denosumab	—

Countries

Africa, Asia except Japan, Europe, Japan, North America, Oceania, South America

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026