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Endocrine effects of Toremifene(FARESTON®) and Leuprolide(LEUPLIN®) therapy in premenopausal breast cancer patients

Endocrine effects of Toremifene(FARESTON®) and Leuprolide(LEUPLIN®) therapy in premenopausal breast cancer patients - Endocrine effects of Toremifene(FARESTON®) and Leuprolide(LEUPLIN®) therapy in premenopausal breast cancer patients

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000004294
Enrollment
50
Registered
2010-09-30
Start date
2010-09-01
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

premenopausal breast cancer

Interventions

40mg of toremifene daily p.o for 5 years. 11.25mg of leuprolide acetate every 3 months.

Sponsors

Kyoto Prefectural University of Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1.Stage I-IIIA Breast cancer diagnosed histologically with a breast removed or preserved. aged 20 years or more 2.Positive ER or PR testing by immunohistochemistry (IHC), enzyme immunoassay (EIA) and who meet the criteria of each institution. 3. HER2 negative by IHC or FISH 4.Patient Status (PS): 0 or 1. 5.Fully functional heart, liver, kidneys, and bone marrow. 6.Less than one year since last menstruation under 60 years old or tested premenopausal from estradiol (E2) and follicle-stimulating hormone (FSH) levels. 7.Expected to live for at least three months (or longer) after study commencement. 8.Written consent obtained for study participation.

Exclusion criteria

Exclusion criteria: 1.Previous treatment for the breast cancer. 2.Inflammatory breast cancer or bilateral breast cancer. 3.Bilateral breast cancer 4.Active other malignancies 5.Past history of drug allergy or hypersensitivity. 6.QTc prolongation 7.Hypokalemia 8.Recieved with Class I or III anti-arrhythmia drugs 9.Judged inappropriate by physicians.

Design outcomes

Primary

MeasureTime frame
Endocrine hormone markers—

Secondary

MeasureTime frame
Lipid markers,Bone markers,Safety,DFS,OS—

Countries

Japan

Contacts

Public ContactKoichi Sakaguchi

Kyoto Prefectural University of Medicine Endocrine & Breast Surgery

ksak@koto.kpu-m.ac.jp+81-75-251-5534

Outcome results

None listed

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