Efficacy of Denosumab on Normal BMD in Women Receiving Adjuvant Aromatase Inhibitors for Early Br… (NCT03324932) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Efficacy of Denosumab on Normal BMD in Women Receiving Adjuvant Aromatase Inhibitors for Early Breast Cancer
Japan160 participantsStarted 2017-09-25
Plain-language 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.
Who can participate
Age range20 Years
SexFEMALE
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Inclusion criteria
✓. Patients with infiltrative breast cancer, aged ≥20 years, meeting the following definitions:
✓. Estrogen receptor (ER)- or progesterone receptor (PgR)-positive patients on immunohistochemical (IHC) staining
✓. Females meeting one of the following criteria for menopause:
✓. 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)
✓. 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.)
Exclusion criteria
✕. 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
What they're measuring
1
percentage change in the bone mineral density (BMD) for the lumbar vertebrae (L1-L4) on dual-energy X-ray absorptiometry (DXA)
Timeframe: 12 months after the start of this study
. 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
✕. 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)