UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of Effects of Postoperative Adjuvant Therapy with Anastrozole on Bone in Postmenopausal Women with Breast Cancer
Title of the study (Brief title)	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	Kenichi Inoue
Organization	Saitama Cancer Center
Division name	Breast Oncology
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	Toshihiro Kai
Organization	Saitama Breast Cancer Clinical Study Group; SBCCSG in Omiya Kyoritsu Hospital
Division name	Surgery
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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2005 Year 12 Month 15 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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