Assessment of the Efficacy of Preoperative Endocrine Therapy of Letrozole in Postmenopausal Patients with Hormone-sensitive Breast cancer of Stage IIA to IIB

Assessment of the Efficacy of Preoperative Endocrine Therapy of Letrozole in Postmenopausal Patients with Hormone-sensitive Breast cancer of Stage IIA to IIB - Assessment of the Efficacy of Preoperative Endocrine Therapy of Letrozole in Postmenopausal Patients with Hormone-sensitive Breast cancer of Stage IIA to IIB

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000000881

Enrollment

Registered

2007-11-08

Start date

2007-07-01

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 (2.5 mg Tablet) is internally administered once a day everyday.

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1.Diagnosed histologically as having had invasive breast cancer 2.Postmenopausal women 3.Measurable tumor lesion 4.Clinical stage IIA-IIB 5.ER and/or PgR positive defined with immunohistochemical staining 6.Performance status of 0 to 1 7.Adequate organ function 8.Benefit is expected to be obtained from the preoperative endocrine therapy 9. A written informed consent is obtained

Exclusion criteria

Exclusion criteria: 1.Under chemotherapy and hormone therapy(for tumors) 2.Invasive carcinoma of other organs(less than 5 years after the last treatment) 3.With past history of breast cancer 4.Synchronous bilateral breast cancer 5.Under treatment with the drugs that may influence on the conditions of sex hormone

Design outcomes

Primary

Measure	Time frame
Clinical tumor response rate	—

Secondary

Measure	Time frame
1. Percentage of performing breast- conserving surgery 2.Histological effect in the extensive intraductal component of breast cancer 3.Difference in clinical tumor response effect depending on the expression of HER2 4.Effect for suppressing estradiol concentration in cancer tissues 5.Adverse events	—

Countries

Japan

Contacts

Public ContactKatsuhiro Tanaka

Kawasaki Medical School Department of Breast and Thyroid Surgery

tanakaka@med.kawasaki-m.ac.jp086-462-1111

Outcome results

None listed

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