UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003512 |
|---|---|
| Receipt number | R000004256 |
| Scientific Title | Phase II study of combination chemotherapy with mitomycin and methotrexate for triple negative breast cancer |
| Date of disclosure of the study information | 2010/04/25 |
| Last modified on | 2013/04/22 12:41:59 |
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Basic information
Public title
Phase II study of combination chemotherapy with mitomycin and methotrexate for triple negative breast cancer
Acronym
MM-TN trial
Scientific Title
Phase II study of combination chemotherapy with mitomycin and methotrexate for triple negative breast cancer
Scientific Title:Acronym
MM-TN trial
Region
| Japan |
Condition
Condition
Breast Cancer
Classification by specialty
| Medicine in general | Hematology and clinical oncology | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Efficacy and safety of combination chemotherapy with mitomycin and methotrexate for triple negative breast cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Response rate by combination chemotherapy with mitomycin and methotrexate for triple negative breast cancer
Key secondary outcomes
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
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
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 cycles of FEC100. Then, surgery will be performed. Add weekly paclitaxel after surgery when axillary nodes was positive or pathological response was grade 0, 1.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key 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
Key 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
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshinori Ito |
Organization
Cancer Institute Hospital, Japanese Foundation for Cancer Research
Division name
Department of Medical Oncology, Breast Cancer Center
Zip code
Address
3-8-31, Ariake, Koto-ku, Tokyo, 135-8550 Japan
TEL
03-3520-0111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshinori Ito |
Organization
Cancer Institute Hospital, Japanese Foundation for Cancer Research
Division name
Department of Medical Oncology, Breast Cancer Center
Zip code
Address
3-8-31, Ariake, Koto-ku, Tokyo, 135-8550 Japan
TEL
03-3520-0111
Homepage URL
Sponsor or person
Institute
Cancer Institute Hospital, Japanese Foundation for Cancer Research
Institute
Department
Personal name
Funding Source
Organization
Department of Medical Oncology, Cancer Institute Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 04 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2009 | Year | 09 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 11 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 04 | Month | 20 | Day |
Last modified on
| 2013 | Year | 04 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004256
