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

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

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

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Osteoporosis
• Intervention / Treatment: Drug: Letrozole; Drug: Xianlinggubao; Drug: Zhongyaofufang

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 Type: Interventional
• Enrollment (Actual): 278
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200025
      • Ruijin Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Letrozole; Early Breast Cancer patients receiving adjuvant endocrine therapy Adjuvant Endocrine Therapy: letrozole 2.5 mg qd po.	Drug: Letrozole; Letrozole endocrine therapy for 2.5mg qd po.; Other Names: L
Active Comparator: Letrozole + Xinglinggubao; Early Breast Cancer patients receiving adjuvant endocrine therapy plus Xianlinggubao Adjuvant Endocrine Therapy: letrozole 2.5 mg qd po. Xinglinggubao: 0.5g bid po	Drug: Letrozole; Letrozole endocrine therapy for 2.5mg qd po.; Other Names: L; Drug: Xianlinggubao; Traditional Chinese Medicine for patients with Osteoporosis; Other Names: X
Active Comparator: Letrozole + 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	Drug: Letrozole; Letrozole endocrine therapy for 2.5mg qd po.; Other Names: L; Drug: Zhongyaofufang; Traditional Chinese Medicine for patients with Osteoporosis; Other Names: Z

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bone Frature Rate	the rate of bone fracture in patient receiving endocrine therapy	1 year
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
Disease Free Survival	the rate of patients without disease	1 year

Collaborators and Investigators

• Sponsor: Shanghai Jiao Tong University School of Medicine
• Investigators: Principal Investigator: Kunwei Shen, MD, Ruijin Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): February 1, 2019
• Study Completion (Actual): September 1, 2019

Study Registration Dates

• First Submitted: May 14, 2015
• First Submitted That Met QC Criteria: May 21, 2015
• First Posted (Estimate): May 27, 2015

Study Record Updates

• Last Update Posted (Actual): April 14, 2020
• Last Update Submitted That Met QC Criteria: April 11, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Osteoporosis; adjuvant endocrine therapy; early breast cancer; Chinese Traditional Medicine
• Additional Relevant MeSH Terms: Metabolic Diseases; Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Breast Neoplasms; Osteoporosis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Aromatase Inhibitors; Steroid Synthesis Inhibitors; Estrogen Antagonists; Letrozole
• Other Study ID Numbers: RJBC1502