Observational study to examine the usefulness of denosumab in postmenopausal breast cancer patients

Observational study to examine the usefulness of denosumab in postmenopausal breast cancer patients - Observational study to examine the usefulness of denosumab in postmenopausal breast cancer patients

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000017328

Enrollment

250

Registered

2015-05-01

Start date

2015-05-01

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

postmenopausal breast cancer patients

Interventions

None listed

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Histologically confirmed breast cancer patients 2. Radical surgery and post-operative irradiation or chemotherapy has been completed. 3. ER and PgR status has been confirmed. 4. ECOG PS of 0-2 at the time of registration 5. Patients without a major organs dysfunction 6. Decreased bone density (T score -1 or less ) 7. Patients who have written consent of participation

Exclusion criteria

Exclusion criteria: 1. Patients with a history of hypersensitivity to aromatase inhibitors and denosumab 2. Patients with bone metastases 3. More than one year have passed after radical surgery. 4. More than six months have passed after start of denosumab 5. Patients undergoing treatment with bisphosphonates

Design outcomes

Primary

Measure	Time frame
The change in bone mineral density , The change of bone metabolism markers , Safety	—

Secondary

Measure	Time frame
Bone metastasis-free survival , Recurrence-free survival , Survival	—

Countries

Japan

Contacts

Public ContactAkira Matsui

Ntional Hospital Organization Breast Suegery Department

matsuiakira@kankakuki.go.jp03-3411-0111

Outcome results