UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000000514
Receipt No. R000000622
Scientific Title Evaluation of Effects of Postoperative Adjuvant Therapy with Anastrozole on Bone in Postmenopausal Women with Breast Cancer
Date of disclosure of the study information 2006/11/06
Last modified on 2017/11/30

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Evaluation of Effects of Postoperative Adjuvant Therapy with Anastrozole on Bone in Postmenopausal Women with Breast Cancer
Acronym Evaluation of Effects of Postoperative Adjuvant Therapy with Anastrozole on Bone in Postmenopausal Women with Breast Cancer (SAFE program: Saitama Anastrozole related Fracture Evaluation program)
Scientific Title Evaluation of Effects of Postoperative Adjuvant Therapy with Anastrozole on Bone in Postmenopausal Women with Breast Cancer
Scientific Title:Acronym Evaluation of Effects of Postoperative Adjuvant Therapy with Anastrozole on Bone in Postmenopausal Women with Breast Cancer (SAFE program: Saitama Anastrozole related Fracture Evaluation program)
Region
Japan

Condition
Condition Hormone-responsive postmenopausal breast cancer
Classification by specialty
Endocrinology and Metabolism Hematology and clinical oncology Breast surgery
Obsterics and gynecology Orthopedics
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 1. To examine effects of postoperative adjuvant therapy with anastrozole on bone in postmenopausal women with breast cancer.
2. To assess Body Mineral Density (BMD) change over time after anastrozole administration.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes Incidence of bone fracture
Key secondary outcomes 1. Incidence of bone fracture in anastrozole therapy combined with alendronate sodium hydrate
2. BMD change in anastrozole alone
3. Body Mass Index (BMI)
4. Safety

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 All study subjects in the adjuvant therapy setting are administrated Anastrozole 1mg/day p.o. for 5years.
Bisphosphonate is prescribed to the subjects who has the low BMD score (<=70%).
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria 1. Primary breast cancer in TNM tumor stage I,II or IIIA
2. Patients who underwent mastectomy or breast conserving surgery
3. Postmenopausal women who meet any of the following criteria
No menstruation for more than one year, or 60 years or over, Postmenopausal levels of follicle-stimulating hormone (FSH) and estradiol (E2), or Bilateral ovariectomy
4. ER and/or PgR-positive primary tumor
5. Adequate renal, hepatic and cardiac function
6. Performance status (PS), (ECOG):0-1
7. Written informed consent was obtained from a patient
Key exclusion criteria 1. Active multiple cancer (simultaneous multiple cancer, and multi-organ invasive cancer with less than 5years of event-free survival)
2. Non-invasive cancer, inflammatory breast cancer
3. Patients with history of osteoporosis or BMD is osteoporosis level (less than 70% of young adult mean (YAM))
4. Patients being treated with bisphosphonate drugs or other osteoporotic drugs
5. Patients diagnosed as having a history of spinal fracure in X-ray or other imagin tests
6. Serious complications (hepatic, renal, cardiac, and endocrine diseases, etc.)
7. Patients with a history of hypersensitivity to any of the ingredients of the study drug
8. Patients judged to be ineligible for participating in the study by investigators
Target sample size 350

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenichi Inoue
Organization Saitama Cancer Center
Division name Breast Oncology
Zip code
Address 818 Komuro, Ina-machi, Kitaadachi-gun, Saitama 362-0806
TEL 048-722-1111
Email ino@cancer-c.pref.saitama.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshihiro Kai
Organization Saitama Breast Cancer Clinical Study Group; SBCCSG in Omiya Kyoritsu Hospital
Division name Surgery
Zip code
Address 1550 Katayanagi, Minuma-ku, Saitama-shi, Saitama 337-0024
TEL 048-686-7155
Homepage URL http://www.sbccsg.org/
Email toshikai@sbccsg.org

Sponsor
Institute Saitama Breast Cancer Clinical Study Group (SBCCSG)
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2006 Year 11 Month 06 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2005 Year 12 Month 15 Day
Date of IRB
Anticipated trial start date
2006 Year 02 Month 01 Day
Last follow-up date
2012 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2006 Year 11 Month 03 Day
Last modified on
2017 Year 11 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000622

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.