Phase II study of combination chemotherapy with mitomycin and methotrexate for triple negative breast cancer

Phase II study of combination chemotherapy with mitomycin and methotrexate for triple negative breast cancer - MM-TN trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000003512

Enrollment

Registered

2010-04-25

Start date

2009-11-01

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

Breast Cancer

Interventions

Metastatic breast cancer: more than 4 cycles of mitomycin + methotrexate (MM), up to 6 times of mitomycin Locally advanced breast cancer: 4 cycles of mitomycin + methotrexate (MM) followed by 4 cycle

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Histological confirmed breast cancer Tumor size 3cm and more in stage IIIA, IIIB, IIIC. Stage IV or metastatic breast cancer Triple negative; ER<10%, PgR<10%, HER2 negative (IHC 0,1 or FISH<2.0) Age below 70 PS;0 or 1 Life expectancy; 6 months and more WBC;4,000/mm3 and more or ANC;2,000/mm3 and more Platelet 100,000/mm3 and more Hemoglobin; 9 g/dl and more AST,ALT; twice of an upper limit of normal value and less Total bilirubin; 1.5 mg/dl and less Creatinine; an upper limit of normal value and less ECG within normal limit Given written consent

Exclusion criteria

Exclusion criteria: Non invasive or microinvasive breast cancer Previously treated with chemotherapy, hormone therapy or radiotherapy Serious complication (infection, cardiac disease, pulmonary fibrosis interstitial pneumonitis, bleeding) Hepatitis type B and its carrier Pregnant, nursing or willing to be pregnant Inadequate to entry judged by investigators

Design outcomes

Primary

Measure	Time frame
Response rate by combination chemotherapy with mitomycin and methotrexate for triple negative breast cancer	—

Secondary

Measure	Time frame
Metastatic breast cancer: progression free survival, time to treatment failure, overall survival, adverse events Locally advanced disease: pathological response rate, pathological complete response rate, clinical response rate, breast conserving rate, disappearance rate of axillary node metastasis, distant-metastasis free survival, disease free survival, overall survival, adverse events	—

Countries

Japan

Contacts

Public ContactYoshinori Ito

Cancer Institute Hospital, Japanese Foundation for Cancer Research Department of Medical Oncology, Breast Cancer Center

03-3520-0111

Outcome results

None listed

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