Traditional Chinese Medicine as Preventive Method for Osteoporosis Induced by Adjuvant Endocrine Therapy

Phase 2

Completed

• Conditions: Osteoporosis; Breast Cancer
• Interventions: Drug: Letrozole; Drug: Zhongyaofufang; Drug: Xianlinggubao

• Registration Number: NCT02455154
• Lead Sponsor: Shanghai Jiao Tong University School of Medicine

Brief Summary

To test the efficacy of two Traditional Chinese Medicine in preventing osteoporosis in patients receiving adjuvant endocrine therapy.

Detailed Description

Breast cancer is the most common malignant tumor in female wolrdwide. Results from clinical trials like ATAC trial have demonstrated the efficacy of AIs in postmenopausal breast cancer patients. Meanwhile it may cause a certain rate of osteoporosis in postmenopausal patients. The aim of this trial is to test the efficacy of two traditional Chinese medicine in preventing osteoporosis in patients receiving adjuvant endocrine therapy.

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2015-05-14
• Study First Submitted QC: 2015-05-21
• Study First Posted: 2015-05-27
• Primary Completion: 2019-02
• Study Completion: 2019-09
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-11
• Last Update Posted: 2020-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 278

Inclusion Criteria

• Histologically confirmed invasive breast cancer;
• Post-surgery, primary lesion been removed;
• Post-Menopausal patients or pre-menopausal patients who will receive ovarian function suppression;
• Histologically confirmed ER and/or PR positive ;
• Receiving adjuvant AIs therapy in the following one years;
• Leukocyte ≥ 3*10(9)/L; Platelets ≥ 75*10(9)/L;
• Serum glutamate oxaloacetate(AST/SGOT) or serum glutamic-pyruvic transaminase(ALT/SGPT) <2.5 times of upper limit of normal range;
• Serum creatinine/blood urea nitrogen(BUN) ≤ upper limit of normal (UNL) range;
• Written informed consent according to the local ethics committee equirements;

Exclusion Criteria

• Metastatic Breast Cancer;
• Received Neo-Adjuvant Endocrine Therapy;
• History of pelvic fracture or bone metabolic disease;
• Received drugs interfering bone metabolism in the last 12 months;
• Baseline Bone Mineral Density: T < -2SD;
• With other primary malignant disease;
• With severe non-malignant co-morbidity that will influence long-term follow up;
• Known severe hypersensitivity to any drugs in this study;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Letrozole + Zhongyaofufang	Zhongyaofufang	Early Breast Cancer patients receiving adjuvant endocrine therapyplus Zhongyaofufang (Traditional Chinses Medicine) Adjuvant Endocrine Therapy: letrozole 2.5 mg qd po. Zhongyaofufang: qow po
Letrozole + Xinglinggubao	Xianlinggubao	Early Breast Cancer patients receiving adjuvant endocrine therapy plus Xianlinggubao Adjuvant Endocrine Therapy: letrozole 2.5 mg qd po. Xinglinggubao: 0.5g bid po
Letrozole + Xinglinggubao	Letrozole	Early Breast Cancer patients receiving adjuvant endocrine therapy plus Xianlinggubao Adjuvant Endocrine Therapy: letrozole 2.5 mg qd po. Xinglinggubao: 0.5g bid po
Letrozole	Letrozole	Early Breast Cancer patients receiving adjuvant endocrine therapy Adjuvant Endocrine Therapy: letrozole 2.5 mg qd po.
Letrozole + Zhongyaofufang	Letrozole	Early Breast Cancer patients receiving adjuvant endocrine therapyplus Zhongyaofufang (Traditional Chinses Medicine) Adjuvant Endocrine Therapy: letrozole 2.5 mg qd po. Zhongyaofufang: qow po

Primary Outcome Measures

Name	Time	Method
Change of Bone Mineral Density	1 year	The change of bone mineral density of the L2-L4 region of the spine and hip between pre- and post-endocrine therapy for one year

Secondary Outcome Measures

Name	Time	Method
Bone Frature Rate	1 year	the rate of bone fracture in patient receiving endocrine therapy
Bone Metabolism	1 year	The change of bone metabolism assessed by the scale of serum bone alkaline phosphatase, serum C-telopeptide and urineN-telopeptide between pre- and post-endocrine therapy for one year
Disease Free Survival	1 year	the rate of patients without disease

Trial Locations

Locations (1)

Ruijin Hospital; 🇨🇳 Shanghai, Shanghai, China