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High-Dose TOREMIFENE for non-steroidal AI failure

High-Dose TOREMIFENE for non-steroidal AI failure - HI-TORE Study

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000003178
Enrollment
60
Registered
2010-02-13
Start date
2010-02-01
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

Recurrent breast cancer

Interventions

high-dose toremifene 120mg/body

Sponsors

Hiroshima Breast Cancer Study Group
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Case confirmed by pathological diagnosis. 2. Postmenopausal women with breast cancer by mastectomy or breast conserving surgery. 3. Recurrent breast cancer patients who are taking anastorozole or letrozole as an adjuvant therapy. 4. Recurrent breast cancer patients who have finished anastorozole or letrozole as an adjuvant therapy less than 1 year ago. 5. Case with measurable primary lesions. 6. Case with positive ER or PgR. 7. Case with PS 0 or 1. 8. Case with a satisfactory function of a heart liver kidney bone marrow ant to satisfy the next condition. 9. Case stopped anastorozole or letrozole more than 2 weeks ago. 10. Case that last menstration was observed more than 1 year ago. 11. Case that survival more than 3 months is anticipated. 12. Case signedinformed consent of the patients for the registration.

Exclusion criteria

Exclusion criteria: (1)Contraindication case for toremifene. (2)Case with inflammatory breast cancer or bilateral breast cancer. (3)Case with active other malignancies. (4)Case with life-threatening metastasis. (5)Case with past history of drug allergy or hypersensitivity. (6)Case with past use of anti-estrogen drug. (7)Case judged inappropriate by physicians.

Design outcomes

Primary

MeasureTime frame
.Clinical benefit .Response Rate (CR, PR)

Secondary

MeasureTime frame
.TTP(Time to progression) .TTF(Time to treatment failure)

Countries

Japan

Contacts

Public ContactShoichiro Ohtani

Hiroshima Breast Cancer Study Group Hiroshima Cancer Support

sho_ohtani@hotmail.com0825443770

Outcome results

None listed

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