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Effect of High-dose Toremifene for premenopausal metastatic breast cancer

Effect of High-dose Toremifene for premenopausal metastatic breast cancer - Multi04 trial

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000002867
Enrollment
25
Registered
2009-12-24
Start date
2009-12-01
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

premenopausal metastatic breast cancer

Interventions

a combination of a gonadotropin-releasing hormone agonist goserelin or Leuprorelin Acetate, and a high-dose toremifene until disease progression.

Sponsors

Multi Hormone Study Group
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: premenopausal women with metastatic or locally advanced breast cancer who had previously been treated with gonadotropin-releasing hormone agonist and tamoxifen or aromatase inhibitor

Exclusion criteria

Exclusion criteria: Patients have an inadequte organ function. Patients who have had any previous or concomitant malignancy. Patients who have had any other non-malignant systemic diseases (cardiovascular, renal lung, etc. ) that would prevent follow-up

Design outcomes

Primary

MeasureTime frame
Clinical Benefit

Secondary

MeasureTime frame
clinical response rate Time to progression Time to treatment failure adverse events

Countries

Japan

Contacts

Public ContactNobuaki Sato

Niigata Cancer Center Hospital Department of Surgery

nobus@niigata-cc.jp81-25-266-5111

Outcome results

None listed

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