UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003835 |
|---|---|
| Receipt number | R000004533 |
| Scientific Title | UFT monotherapy as adjuvant chemotherapy for HER2 negative breast cancer patients who did not achieve pathologic complete response (non-pCR) after neoadjuvant chemotherapy: Phase 2 study. |
| Date of disclosure of the study information | 2010/07/05 |
| Last modified on | 2014/01/28 20:50:43 |
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Basic information
Public title
UFT monotherapy as adjuvant chemotherapy for HER2 negative breast cancer patients who did not achieve pathologic complete response (non-pCR) after neoadjuvant chemotherapy: Phase 2 study.
Acronym
UFT monotherapy for non-pCR patients treated with neoadjuvant chemotherapy.
Scientific Title
UFT monotherapy as adjuvant chemotherapy for HER2 negative breast cancer patients who did not achieve pathologic complete response (non-pCR) after neoadjuvant chemotherapy: Phase 2 study.
Scientific Title:Acronym
UFT monotherapy for non-pCR patients treated with neoadjuvant chemotherapy.
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Hematology and clinical oncology | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To confirm the feasibility and safety of UFT monotherapy as adjuvant chemotherapy for HER2 negative breast cancer patients who did not achieve pathologic complete response after neoadjuvant chemotherapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
feasibility
Key secondary outcomes
Safety, disease free survival, overall survival
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
UFT 270 mg/m2 (daily oral administration)
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Female
Key inclusion criteria
1. Female breast cancer patients over 20 who were histologically diagnosed as primary breast cancer (invasive carcinoma).
2. Stage II-III patients who underwent curative operation.
3. Cases with histologically diagnosed residual invasive cancer after preoperative chemotherapy including anthracycline.
4. HER2 negative cases.
5. 0 to 1 ECOG performance status.
6. No carry-over effect of prior treatment.
7. Good organ function.
8. Cases with no carry-over grade 2 or more adverse drug effect.
9. Written informed consent.
Key exclusion criteria
1. Necessary for adjuvant chemotherapies other than UFT.
2. Treated with oral 5-FU agents previously.
3. Pregnant or breastfeeding.
4. Willing for or possibilities of pregnancy.
5. Recieved the organ transplantation previously.
6. Hypersensitive or underwent severe adverse reactions to fluoropyrimidine.
7. Suffered from serious complications.
8. Having fever or possibility of the infection.
9. Metastatic breast cancer.
10. Having past history or treatment of epilepsy, central nurve system disorder, or psychiatric disease.
11. Difficulty with taking oral drugs or upper gastrointestinal function, or malabsorption syndrome.
12. Judged to be ineligible by the investigators.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsuhiko Iwamoto |
Organization
Osaka Medical College Hospital
Division name
General and gastroenterological surgery
Zip code
Address
Daigaku-machi 2-7, Takatsuki city Osaka, Japan
TEL
072-683-1221
sur112@poh.osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoru Tanaka |
Organization
Osaka Medical College Hospital
Division name
General and gastroenterological surgery
Zip code
Address
Daigaku-machi 2-7, Takatsuki city Osaka, Japan
TEL
072-683-1221
Homepage URL
sur112@poh.osaka-med.ac.jp
Sponsor or person
Institute
Osaka Medical College Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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 | 07 | Month | 05 | 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
| 2010 | Year | 06 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 06 | Month | 28 | Day |
Last modified on
| 2014 | Year | 01 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004533
