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

Breast Cancer Clinical Trial

— COAT  

Official title:

Traditional Chinese Medicine as Preventive Method for Osteoporosis in Early Breast Cancer Patients Receiving Adjuvant Endocrine Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02455154
• Other study ID #: RJBC1502
• Status: Completed
• Phase: Phase 2
• Start date: May 2015
• Est. completion date: September 2019

Study information

• Verified date: April 2020
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 278
• Est. completion date: September 2019
• Est. primary completion date: February 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Osteoporosis

Intervention

Drug:
• Letrozole
Letrozole endocrine therapy for 2.5mg qd po.
• Zhongyaofufang
Traditional Chinese Medicine for patients with Osteoporosis
• Xianlinggubao
Traditional Chinese Medicine for patients with Osteoporosis

Locations

Country	Name	City	State
China	Ruijin Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Bone Mineral Density	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	1 year
Secondary	Bone Frature Rate	the rate of bone fracture in patient receiving endocrine therapy	1 year
Secondary	Bone Metabolism	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	1 year
Secondary	Disease Free Survival	the rate of patients without disease	1 year