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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001552

Enrollment

200

Registered

2008-12-05

Start date

2008-12-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

postmenopausal breast cancer

Interventions

Letrozole 2.5mg daily p.o. as adjuvant therapy

Eligibility

Sex/Gender

Female

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Change rate of FACT-ES score	—

Secondary

Measure	Time frame
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	—

Countries

Japan

Contacts

Public ContactToshihiro Kai

NPO Saitama Breast Cancer Clinical Study Group (SBCCSG) Executive office(c/o: Shin-toshin Ladies MammoClinic)

toshikai@sbccsg.org048-600-1722

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026