UMIN-CTR Clinical Trial

Public title

Health-related quality of life of postmenopausal women treated with Letrozole as adjuvant therapy for hormone receptor-positive early breast cancer (SBCCSG-15)

Acronym

Health-related quality of life of postmenopausal women treated with Letrozole as adjuvant therapy for hormone receptor-positive early breast cancer (SBCCSG-15)

Scientific Title

Health-related quality of life of postmenopausal women treated with Letrozole as adjuvant therapy for hormone receptor-positive early breast cancer (SBCCSG-15)

Scientific Title:Acronym

Health-related quality of life of postmenopausal women treated with Letrozole as adjuvant therapy for hormone receptor-positive early breast cancer (SBCCSG-15)

Region

Japan

Condition

postmenopausal breast cancer

Classification by specialty

Hematology and clinical oncology

Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

Evaluate health related quality of life during treated with Letrozole as adjuvant therapy for hormone receptor-positive early breast cancer and analyze by the difference of baseline characteristics ( e.g age, comorbidity, treatment ). Assess arthralgia, one of the most common adverse events, in detail.

Basic objectives2

Others

Basic objectives -Others

HRQOL

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Change rate of FACT-ES score

Key secondary outcomes

Change rate of FACT-G score
Arthralgia related with AI
FACT-ES score by baseline characters before and after treatment
Difference of the evaluation of arthralgia between investigators and patients-self

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

Letrozole 2.5mg daily p.o. as adjuvant therapy

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. histologically diagnosed with unilateral primary breast cancer, stage 0-IIIC. ( previous local radiotherapy and/or systemic chemotherapy are allowed )
2. ER and/or PgR positive
3. PS(ECOG)0,1
4. postmenopausal patients who satisfies one or more below criteria;
A. age 60 or more
B. Prior bilateral oophorectomy
C. amenorrheic for 1 year or more
D. FSH and plasma estradiol level in postmenopausal ranges
5. adequate major organ function
6. informed consent has been obtained in writing

Key exclusion criteria

1. patients have been treated with medicine which may have some effect for sex hormone or trastuzumab
2. patients being treated with chemotherapy
3. Serious complications ( e.g malignant hypertension, CHF, hepatic failure, MI within 6 months, PE, arrhythmia treatment needed, infection, hemorrhagic tendency )
4. active multiple cancer

Target sample size

200

Name of lead principal investigator

1st name
Middle name
Last name	Toshio Tabei

Organization

Saitama Cancer Center

Division name

Breast Oncology

Zip code

Address

818 Komuro Ina Kitaadachi, Saitama 362-0806

TEL

048-722-1111

Email

toshikai@sbccsg.org

Name of contact person

1st name
Middle name
Last name	Toshihiro Kai

Organization

NPO Saitama Breast Cancer Clinical Study Group (SBCCSG)

Division name

Executive office(c/o: Shin-toshin Ladies MammoClinic)

Zip code

Address

3F, Capital Bldg. 4-261-1, Kishiki-cho, Omiya-ku, Saitama-City 330-0843, Saitama Prefecture

TEL

048-600-1722

Homepage URL

http://www.sbccsg.org/

Email

toshikai@sbccsg.org

Institute

NPO 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

2008

Year

12

Month

05

Day

URL releasing protocol

Publication of results

Unpublished

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

2008

Year

10

Month

07

Day

Date of IRB

Anticipated trial start date

2008

Year

12

Month

01

Day

Last follow-up date

2011

Year

12

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2008

Year

12

Month

04

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=R000001875