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

Primary Purpose

Breast Cancer, Osteoporosis

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Letrozole
Zhongyaofufang
Xianlinggubao
Sponsored by
Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breast Cancer focused on measuring Chinese Traditional Medicine, Osteoporosis, adjuvant endocrine therapy, early breast cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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;

Sites / Locations

  • Ruijin Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

Letrozole

Letrozole + Xinglinggubao

Letrozole + Zhongyaofufang

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Bone Frature Rate
the rate of bone fracture in patient receiving endocrine therapy
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
Disease Free Survival
the rate of patients without disease

Full Information

First Posted
May 14, 2015
Last Updated
April 11, 2020
Sponsor
Shanghai Jiao Tong University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02455154
Brief Title
Traditional Chinese Medicine as Preventive Method for Osteoporosis Induced by Adjuvant Endocrine Therapy
Acronym
COAT
Official Title
Traditional Chinese Medicine as Preventive Method for Osteoporosis in Early Breast Cancer Patients Receiving Adjuvant Endocrine Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
February 2019 (Actual)
Study Completion Date
September 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Jiao Tong University School of Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Osteoporosis
Keywords
Chinese Traditional Medicine, Osteoporosis, adjuvant endocrine therapy, early breast cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
278 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Letrozole
Arm Type
Placebo Comparator
Arm Description
Early Breast Cancer patients receiving adjuvant endocrine therapy Adjuvant Endocrine Therapy: letrozole 2.5 mg qd po.
Arm Title
Letrozole + Xinglinggubao
Arm Type
Active Comparator
Arm 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
Arm Title
Letrozole + Zhongyaofufang
Arm Type
Active Comparator
Arm 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
Intervention Type
Drug
Intervention Name(s)
Letrozole
Other Intervention Name(s)
L
Intervention Description
Letrozole endocrine therapy for 2.5mg qd po.
Intervention Type
Drug
Intervention Name(s)
Zhongyaofufang
Other Intervention Name(s)
Z
Intervention Description
Traditional Chinese Medicine for patients with Osteoporosis
Intervention Type
Drug
Intervention Name(s)
Xianlinggubao
Other Intervention Name(s)
X
Intervention Description
Traditional Chinese Medicine for patients with Osteoporosis
Primary Outcome Measure Information:
Title
Change of Bone Mineral Density
Description
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
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Bone Frature Rate
Description
the rate of bone fracture in patient receiving endocrine therapy
Time Frame
1 year
Title
Bone Metabolism
Description
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
Time Frame
1 year
Title
Disease Free Survival
Description
the rate of patients without disease
Time Frame
1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kunwei Shen, MD
Organizational Affiliation
Ruijin Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ruijin Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China

12. IPD Sharing Statement

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

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