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

  • STATUS
    Recruiting
  • End date
    Sep 18, 2027
  • participants needed
    160
  • sponsor
    Kyoto Prefectural University of Medicine
Updated on 18 April 2022
estrogen
endocrine therapy
progesterone
hormone therapy
adjuvant therapy
estradiol
bisphosphonate
progesterone receptor
aromatase inhibitor
estrogen receptor
mastectomy
letrozole
arimidex
immunostimulant

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.

Description

Normal BMD means T score is ≥-1.0 for the lumbar vertebrae (L1-L4) and/or the femoral neck.

Details
Condition Breast Cancer
Treatment Denosumab Injection
Clinical Study IdentifierNCT03324932
SponsorKyoto Prefectural University of Medicine
Last Modified on18 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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 who underwent bilateral oophorectomy
Those, aged <55 years, with amenorrhea for ≥12 months, or those diagnosed with menopause by attending physicians based on the FSH and estradiol levels
Patients without lumbar vertebral or femoral fracture
Patients in whom the BMD for the lumbar vertebrae (L1-L4) on DXA before the start of
Those with an ECOG PS of 0-2
this study is ≥-1.0SD of the mean value of young adult females (YAM), and the
Those with adequate organ functions (laboratory data within 4 weeks before case registration)
BMD for the femoral neck is ≥-1.0SD of YAM
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
Those from whom written informed consent regarding study participation was obtained
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

Exclusion Criteria

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