UMIN-CTR Clinical Trial

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

Hormone-responsive postmenopausal breast cancer

Classification by specialty

Endocrinology and Metabolism	Hematology and clinical oncology	Breast surgery
Obstetrics and Gynecology	Orthopedics

Classification by malignancy

Malignancy

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Saitama Breast Cancer Clinical Study Group (SBCCSG)

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2006

Year

11

Month

06

Day

URL releasing protocol

Publication of results

Partially published

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

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 related information

Registered date

2006

Year

11

Month

03

Day

Last modified on

2017

Year

11

Month

30

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000622