Investigation of the Efficacy of Pre-operative Endocrine Therapy with Toremifene cirate and Exemestane for Postmenopausal Breast Cancer Patients

Investigation of the Efficacy of Pre-operative Endocrine Therapy with Toremifene cirate and Exemestane for Postmenopausal Breast Cancer Patients - Investigation of the Efficacy of Pre-operative Endocrine Therapy with Toremifene cirate and Exemestane for Postmenopausal Breast Cancer Patients

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007014

Enrollment

Registered

2012-01-04

Start date

2011-10-01

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

Hormone-receptor positive postmenopausal breast cancer patients

Interventions

Tormifene (40mg) and exemestane(25mg) are administered for 16 days continuously prior to the operation

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Brest cancer is histologically confirmed 2. Postmenopausal females 3. The values of E2, LH and FSH show postmenopausal value if the patient's cervical has been resected 4. Measurable lesion including primary lesion 5. Stage II or III (Tumor size is 3 cm or longer) 6. Primary lesion of ER or PgR are positive 7. Performance status 0 -1 8. Pretreatment has not been done to the cancer 9. Operation of breast cancer is scheduled after endocrine therapy 10. No severe complications and each organ functions satisfy the conditions below by the clinical laboratory test 1) WBC more than 4000/mm3 and not more than 10000/mm3, Pl more than 100000/mm3, Hb more than10g/dl 2) T Bil not more than1mg/dl, GOT not more than 60 IU/L, GPT not more than 60 IU/L 11. Written informed consent is obtained

Exclusion criteria

Exclusion criteria: 1. Inflammatory breast cancer 2. Active double cancer 3. Severe heart diseases including myocardial infarction, cardiac insufficiency or patients who have a medical history in these diseases 4. Medical history in deep vein thrombosis 5. Cirrhosis 6. Fever with more than 38 degree 7. Patients who have bleeding tendency 8. Patients who are judged as ineligible for the study enrollment by investigators

Design outcomes

Primary

Measure	Time frame
Clinical response rate	—

Secondary

Measure	Time frame
Histological therapeutic effect Rate of breast-conserving surgery Safety Change of Ki 6 7, Change of ER/PgR/HER2	—

Countries

Japan

Contacts

Public ContactTempei, Miyaji

The University of Tokyo Interfaculty Initiative in Information Studies

tempeimiyaji@iii.u-tokyo.ac.jp

Outcome results

None listed

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