The efficacy of re-challenge of denosumab in postmenopausal women with hormone receptor-positive breast cancer who are currently on or will iniate an aromatase inhibitor in the adjuvant setting

The efficacy of re-challenge of denosumab in postmenopausal women with hormone receptor-positive breast cancer who are currently on or will iniate an aromatase inhibitor in the adjuvant setting - The efficacy of re-challenge of denosumab in postmenopausal women with hormone receptor-positive breast cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000030328

Enrollment

Registered

2017-12-09

Start date

2015-10-31

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

subcutaneous injection of denosumab every 6 months

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1) Adequately diagnosed and treated invasive breast cancer defined as 1.Clinical stage 1,2 or 3a 2.Patients with breast cancer whose tumor were removed by an appropriate surgical procedure such as mastectomy or breast conserving surgery 2) ER and PgR positive defined with immunohistochemical staining 3) Postmenopausal status defined by one of the following 1.women >54 years with cessation of menses 2.spontaneous cessation of menses within the past 1 years, but amenorrheic in women <55 years, and according to the definition of 'postmenopausal range' for FSH and estradiol level 3.bilateral oophorectomy 4) Lumbar spine, total hip or femoral neck BMD equivalent to a YAM classification of -1.0 to -2.5 5) ECOG Performance status of 0 to 2 6) Patients who have completed chemothrapy >4 weeks prior to study entry 7) Patients who have discontinued the following drugs known as affect to the skeleton more than 4 weeks oral bisphosphonates, estrogen, raloxifene, calcitonin, vitamin K, activated vitamin D, ipriflavone 8) A written informed consent is obtained

Exclusion criteria

Exclusion criteria: 1) Diagnosis of clinical or radiological disant metastasis before inclusion 2) Invasive bilateral breast cancer 3) Received prior treatment with intravenous bisphosphonates within the past 12 months 4) Following diseases which may interfere with DXA scan such as severe scoliosis, vertebral diseases 5) Current active dental problems including infection of the teeth or jawbone. Recent (within 6 weeks) or planned dental or jaw surgery(e.g., extraction, implants) 6) Other conditions judged as inappropriate for the study by the investigator

Design outcomes

Primary

Measure	Time frame
the percent change in lumbar spine(L1-L4)BMD from discontinuation to 12 month after	—

Countries

Japan

Contacts

Public Contactyoshimi ouchi

Kyoto Prefectural University of medicine Department of Endocrine and Breast Surgery

y-ouchi@koto.kpu-m.ac.jp075-251-5534

Outcome results

None listed

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