UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005100 |
|---|---|
| Receipt number | R000006058 |
| Scientific Title | A Phase II trial of S-1 and Docetaxel followed by FEC as neoadjuvant chemotherapy for primary breast cancer |
| Date of disclosure of the study information | 2011/02/20 |
| Last modified on | 2011/02/17 02:05:37 |
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Basic information
Public title
A Phase II trial of S-1 and Docetaxel followed by FEC as neoadjuvant chemotherapy for primary breast cancer
Acronym
A Phase II trial of S-1 and Docetaxel followed by FEC as neoadjuvant chemotherapy for primary breast cancer
Scientific Title
A Phase II trial of S-1 and Docetaxel followed by FEC as neoadjuvant chemotherapy for primary breast cancer
Scientific Title:Acronym
A Phase II trial of S-1 and Docetaxel followed by FEC as neoadjuvant chemotherapy for primary breast cancer
Region
| Japan |
Condition
Condition
Breast Cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the efficacy and safety of S-1 with Docetaxel followed by FEC as neoadjuvant chemotherapy for primary breast cancer.
Primary endpoint is to evaluate the pathological CR rate.
Secondary endpoint is to evaluate the clinical response rate and relapse- free survival and safety.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Primary endpoint is to evaluate the pathological CR rate.
Key secondary outcomes
Secondary endpoint is to evaluate the clinical response rate and relapse- free survival and safety.
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
4 cycles of S-1/Docetaxel followed by FEC.
Docetaxel 40 mg/m2 will be given i.v. on day 1 in combination with S-1 80 mg/m2 orally twice daily on days 1-4 every 21 days.
FEC (5-FU 500 mg/m2, Epi-ADM 100 mg/m2 and CPA 500 mg/m2) is administered intravenously on day 1 every 21 days.
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) Histologically confirmed primary breast cancer
2) Clinical stage T1-3 N0-1 M0
3) Age > 20 years and < 80 years
4) No prior surgery, radiation, chemotherapy and endocrine therapy
5) Required baseline laboratory parameters (within 14 days before registration)
Hb: more than 9.0 g/dl
WBC: more than 4000 /mm3 and less than 12,000 /mm3
Neu: more than 2,000 / mm3
Plt: more than 100,000/mm3
T-Bil: less than 2 times ULM
AST: less than 2 times ULN
ALT: less than 2 times ULN
Cre: less than ULN
Ccr: more than 60 ml/min
6) ECOG performance status of 0 - 2
Key exclusion criteria
1) Inflammatory breast cancer and bilateral breast cancer
2) Previous (less than 5 years) or current history of malignant neoplasm
3) Known immediate or delayed hypersensitivity reaction or contraindication to drugs chemically related to any of the study treatment
4) Severe complications (uncontrolled diabetes mellitus, heart failure, interstitial pneumonia or pulmonary fibrosis etc.)
5) Sever bone marrow suppression
6) Renal dysfunction (serum Cre is more than ULN), liver dysfunction ( T-Bil or AST/ALT is more than 2.5 times ULN )
7) During administration of fluoropyrimidines
8) Active infection (more than 38.0C)
9) During administration of flucytosine, phenytoin, warfarin potassium
10) During administration of pentostatin
11) During pregnancy or lactation
12) Patients judged inappropriate by physicians
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiromitsu Jinno |
Organization
Keio University School of Medicine
Division name
Department of Surgery
Zip code
Address
35 Shinanomachi Shinjuku, Tokyo, Japan
TEL
03-3353-1211
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiromitsu Jinno |
Organization
Keio University School of Medicine
Division name
Department of Surgery
Zip code
Address
35 Shinanomachi Shinjuku, Tokyo, Japan
TEL
03-3353-1211
Homepage URL
jinno@sc.itc.keio.ac.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Keio University School of Medicine
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
慶應義塾大学病院
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 02 | Month | 20 | 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
Suspended
Date of protocol fixation
| 2010 | Year | 10 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
| 2020 | Year | 11 | Month | 01 | Day |
Date trial data considered complete
| 2020 | Year | 11 | Month | 01 | Day |
Date analysis concluded
| 2020 | Year | 11 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 02 | Month | 17 | Day |
Last modified on
| 2011 | Year | 02 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006058
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