Overview

Efficacy of Denosumab on Normal BMD in Women Receiving Adjuvant Aromatase Inhibitors for Early Breast Cancer

Status:
Recruiting
Trial end date:
2027-09-01
Target enrollment:
0
Participant gender:
Female
Summary
This multicenter, randomized, comparative study will evaluate the efficacy of denosumab to prevent the adjuvant therapy of aromatase inhibitors-induced loss of bone mineral density (BMD) in breast cancer patients with normal BMD. Investigators will compare the inhibitory effects of denosumab on bone loss between participants with normal BMD to whom Letrozole or Arimidex will be administered as postoperative endocrine therapy for stage I-IIIA postmenopausal hormone-sensitive breast cancer and controls.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Kyoto Prefectural University of Medicine
Treatments:
Aromatase Inhibitors
Denosumab
Criteria
Inclusion Criteria:

Patients must meet all of the following items at the time of case registration:

1. Patients with infiltrative breast cancer, aged ≥20 years, meeting the following
definitions:

- Those pathologically diagnosed with stage I, II, or IIIA breast cancer (Cancer
Management Regulations, 11th version)

- Those who underwent appropriate surgery, such as mastectomy and breast-preserving
surgery

2. Estrogen receptor (ER)- or progesterone receptor (PgR)-positive patients on
immunohistochemical (IHC) staining

3. Females meeting one of the following criteria for menopause:

- Those, aged ≥55 years, without menstruation

- Those, aged <55 years, with amenorrhea for ≥12 months, or those diagnosed with
menopause by attending physicians based on the FSH and estradiol levels

- Those who underwent bilateral oophorectomy

4. Patients in whom the BMD for the lumbar vertebrae (L1-L4) on DXA before the start of
this study is ≥-1.0SD of the mean value of young adult females (YAM), and the BMD for
the femoral neck is ≥-1.0SD of YAM

5. Patients without lumbar vertebral or femoral fracture

6. Those with an ECOG PS of 0-2

7. Those with adequate organ functions (laboratory data within 4 weeks before case
registration)

- Leukocyte count, ≥3,000/mm3 or Neutrophil count, ≥1,500/mm3

- AST, ALT, ≤1.5-fold of the upper limit of the institutional reference range

- Serum creatinine, ≤1.5-fold of the upper limit of the institutional reference
range

8. Case registration should be performed before the following point:Twelve weeks after
the completion of surgery or postoperative chemotherapy (The completion of
chemotherapy refers to the completion of the final course, involving the recovery
phase.)

9. Patients with an interval of ≥4 weeks after the discontinuation of therapy with
bisphosphonates (oral preparations), estrogen preparations, raloxifene, calcitonin
preparations, vitamin K preparations, active vitamin D preparations, or ipriflavone
preparations, which influence bones

10. Those from whom written informed consent regarding study participation was obtained

Exclusion Criteria:

Whether each patient meets any of the following items must be checked on case registration:

1. Patients in whom distant metastasis was confirmed clinically or using imaging
procedures at the time of case registration

2. Those with bilateral breast cancer

3. Those for whom postoperative hormonal therapy was started before consenting to study
participation

4. Those who received endocrine therapy within 52 weeks before consenting to study
participation

5. Those to whom bisphosphonate preparations were intravenously administered within 52
weeks before consenting to study participation

6. Those with the following diseases that may affect DXA

- Severe scoliosis, immobility, hyperostosis or osteosclerosis of the lumbar
vertebrae, calcification of the abdominal aorta, and vertebral disease

7. Those with a history of malignant tumors other than breast cancer within 260 weeks
before consenting to study participation

8. Those with dental diseases, such as infectious diseases of the teeth or jaw and tooth
trauma. Those for whom tooth or jaw surgery is scheduled within 6 weeks after
consenting to study participation (tooth extraction, implantation)

9. Others who are considered to be ineligible by the chief investigator