NCT02455154

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
278

participants targeted

Target at P75+ for phase_2 breast-cancer

Timeline
Completed

Started May 2015

Typical duration for phase_2 breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

May 14, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 27, 2015

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

April 14, 2020

Status Verified

April 1, 2020

Enrollment Period

3.8 years

First QC Date

May 14, 2015

Last Update Submit

April 11, 2020

Conditions

Breast CancerOsteoporosis

Keywords

Chinese Traditional MedicineOsteoporosisadjuvant endocrine therapyearly breast cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Bone Frature Rate

    1 year

  • Bone Metabolism

    1 year

  • Disease Free Survival

    1 year

Study Arms (3)

Letrozole

PLACEBO COMPARATOR

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

Drug: Letrozole

Letrozole + Xinglinggubao

ACTIVE COMPARATOR

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: LetrozoleDrug: Xianlinggubao

Letrozole + Zhongyaofufang

ACTIVE COMPARATOR

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: LetrozoleDrug: Zhongyaofufang

Interventions

LetrozoleDRUG

Letrozole endocrine therapy for 2.5mg qd po.

Also known as: L
LetrozoleLetrozole + XinglinggubaoLetrozole + Zhongyaofufang
ZhongyaofufangDRUG

Traditional Chinese Medicine for patients with Osteoporosis

Also known as: Z
Letrozole + Zhongyaofufang
XianlinggubaoDRUG

Traditional Chinese Medicine for patients with Osteoporosis

Also known as: X
Letrozole + Xinglinggubao

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruijin Hospital

Shanghai, Shanghai Municipality, 200025, China

Location

MeSH Terms

Conditions

Breast NeoplasmsOsteoporosis

Interventions

Letrozolexian ling gu bao

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

NitrilesOrganic ChemicalsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Kunwei Shen, MD

    Ruijin Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 14, 2015

First Posted

May 27, 2015

Study Start

May 1, 2015

Primary Completion

February 1, 2019

Study Completion

September 1, 2019

Last Updated

April 14, 2020

Record last verified: 2020-04

Locations

CN(1)