Status:
ACTIVE_NOT_RECRUITING
Efficacy of Denosumab on Normal BMD in Women Receiving Adjuvant Aromatase Inhibitors for Early Breast Cancer
Lead Sponsor:
Kyoto Prefectural University of Medicine
Conditions:
Breast Cancer
Eligibility:
FEMALE
20+ years
Phase:
PHASE3
Brief 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 can...
Detailed Description
Normal BMD means T score is ≥-1.0 for the lumbar vertebrae (L1-L4) and/or the femoral neck.
Eligibility Criteria
Inclusion
- Patients must meet all of the following items at the time of case registration:
- 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
- Estrogen receptor (ER)- or progesterone receptor (PgR)-positive patients on immunohistochemical (IHC) staining
- 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
- 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
- Patients without lumbar vertebral or femoral fracture
- Those with an ECOG PS of 0-2
- 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
- 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.)
- 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
- Those from whom written informed consent regarding study participation was obtained
Exclusion
- Whether each patient meets any of the following items must be checked on case registration:
- Patients in whom distant metastasis was confirmed clinically or using imaging procedures at the time of case registration
- Those with bilateral breast cancer
- Those for whom postoperative hormonal therapy was started before consenting to study participation
- Those who received endocrine therapy within 52 weeks before consenting to study participation
- Those to whom bisphosphonate preparations were intravenously administered within 52 weeks before consenting to study participation
- 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
- Those with a history of malignant tumors other than breast cancer within 260 weeks before consenting to study participation
- 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)
- Others who are considered to be ineligible by the chief investigator
Key Trial Info
Start Date :
September 25 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT03324932
Start Date
September 25 2017
End Date
December 1 2027
Last Update
October 6 2023
Active Locations (1)
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1
Hisako Ono
Kyoto, Japan, 6028566