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

Shanghai Jiao Tong University School of Medicine

Status and phase: Completed; Phase 2

Conditions: Osteoporosis; Breast Cancer

Treatments: Drug: Letrozole; Drug: Zhongyaofufang; Drug: Xianlinggubao

Study type: Interventional

Funder types: Other

Identifiers

NCT02455154

RJBC1502

Details and patient eligibility

About

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

Full 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.

Enrollment: 278 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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278 participants in 3 patient groups, including a placebo group

Letrozole

Placebo Comparator group

Description:

Early Breast Cancer patients receiving adjuvant endocrine therapy Adjuvant Endocrine Therapy: letrozole 2.5 mg qd po.

Treatment:

Drug: Letrozole

Letrozole + Xinglinggubao

Active Comparator group

Description:

Early Breast Cancer patients receiving adjuvant endocrine therapy plus Xianlinggubao Adjuvant Endocrine Therapy: letrozole 2.5 mg qd po. Xinglinggubao: 0.5g bid po

Treatment:

Drug: Xianlinggubao

Drug: Letrozole

Letrozole + Zhongyaofufang

Active Comparator group

Description:

Early Breast Cancer patients receiving adjuvant endocrine therapyplus Zhongyaofufang (Traditional Chinses Medicine) Adjuvant Endocrine Therapy: letrozole 2.5 mg qd po. Zhongyaofufang: qow po

Treatment:

Drug: Zhongyaofufang

Drug: Letrozole