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Name:
UMIN ID:

Recruitment status Suspended
Unique ID issued by UMIN UMIN000005100
Receipt No. 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

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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
Email

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
Email jinno@sc.itc.keio.ac.jp

Sponsor
Institute Keio University School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006058

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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