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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN C000000322
Receipt No. R000000415
Scientific Title Randomized Phase II Study of Docetaxel (T) with or without Capecitabine (X) as Neoadjuvant Chemotherapy in Female Patients with Operable Breast Cancer Who were not Observed Disease Progression after 4 cycles of 5-Fluorouracil, Epirubicin and Cyclophosphamide (FEC) (OOTR N003)
Date of disclosure of the study information 2006/02/10
Last modified on 2018/03/15

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Basic information
Public title Randomized Phase II Study of Docetaxel (T) with or without Capecitabine (X) as
Neoadjuvant Chemotherapy in Female Patients with Operable Breast Cancer
Who were not Observed Disease Progression after 4 cycles of 5-Fluorouracil, Epirubicin and Cyclophosphamide (FEC)
(OOTR N003)
Acronym Randomized Phase II Study of
Docetaxel (T) with or without Capecitabine (X) as
Neoadjuvant Chemotherapy in Operable Breast Cancer Patients
Who were not Observed Disease Progression after FEC
(OOTR N003)
Scientific Title Randomized Phase II Study of Docetaxel (T) with or without Capecitabine (X) as
Neoadjuvant Chemotherapy in Female Patients with Operable Breast Cancer
Who were not Observed Disease Progression after 4 cycles of 5-Fluorouracil, Epirubicin and Cyclophosphamide (FEC)
(OOTR N003)
Scientific Title:Acronym Randomized Phase II Study of
Docetaxel (T) with or without Capecitabine (X) as
Neoadjuvant Chemotherapy in Operable Breast Cancer Patients
Who were not Observed Disease Progression after FEC
(OOTR N003)
Region
Japan Asia(except Japan)

Condition
Condition Operable breast cancer
Classification by specialty
Hematology and clinical oncology Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The objective of this randomized phase II study is to compare the efficacy of treatment with 4 cycles of 5-fluorouracil, epirubicin and cyclophosphamide (FEC) followed by 4 cycles of docetaxel and capecitabine (TX) to 4 cycles of FEC followed by 4 cycles of docetaxel alone (T) as neoadjuvant chemotherapy in female patients with operable breast cancer {T1C-3 N0 M0(>1cm) / T1-3 N1 M0}
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Pathologic response (pCR rate)
Key secondary outcomes Toxicity
Clinical response
Frequency of breast conservation surgery
Frequency of axillary lymph node conservation surgery
Disease-free survival
Overall survival

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration Institution is not considered as adjustment factor.
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 5-fluorouracil, epirubicin, cyclophosphamide (FEC) followed by docetaxel (T)
Interventions/Control_2 5-fluorouracil, epirubicin, cyclophosphamide (FEC) followed by docetaxel, capecitabine (TX)
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
70 years-old >=
Gender Female
Key inclusion criteria T1C-3 N0 M0(>1cm) / T1-3 N1 M0}
No prior treatment for breast cancer
ECOG performance status (PS) 0-1
Adequate organ funtion
signed a Patients Informed Consent Form
Key exclusion criteria Male
History of drug hypersensitivity
Uncontrolled medical condition
Significant interstitial pneumonia or pulmonary fibrosis by CT scan or x-ray
Suspected of infection with fever
Symptomatic Varicella
Requiring treatment of pleural or pericardial effusions
Severe edema
Severe peripheral neuropathy
Requiring treatment with the steroid is a necessity beforehand
Severe psychiatric disorders
Inflammatory breast cancer
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinji Ohno
Organization The Cancer Institute Hospital Of JFCR (moved from National Hospital Organization Kyushu Cancer Center)
Division name Breast Oncology Center
Zip code
Address 3-8-31, Ariake, Koto, Tokyo 135-8550, Japan
TEL 03-3520-0111
Email sohno@nk-cc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shinji Ohno
Organization The Cancer Institute Hospital Of JFCR (moved from National Hospital Organization Kyushu Cancer Cente
Division name Breast Oncology Center
Zip code
Address 3-8-31, Ariake, Koto, Tokyo 135-8550, Japan
TEL 03-3520-0111
Homepage URL
Email sohno@nk-cc.go.jp

Sponsor
Institute Organization for Oncology and Translational Research (OOTR)
Institute
Department

Funding Source
Organization Organization for Oncology and Translational Research (OOTR)
Organization
Division
Category of Funding Organization Outside Japan
Nationality of Funding Organization Japan

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

Other administrative information
Date of disclosure of the study information
2006 Year 02 Month 10 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 No longer recruiting
Date of protocol fixation
2005 Year 12 Month 14 Day
Date of IRB
Anticipated trial start date
2005 Year 12 Month 01 Day
Last follow-up date
2014 Year 12 Month 01 Day
Date of closure to data entry
2015 Year 02 Month 01 Day
Date trial data considered complete
2015 Year 03 Month 01 Day
Date analysis concluded
2015 Year 04 Month 01 Day

Other
Other related information

Management information
Registered date
2006 Year 02 Month 03 Day
Last modified on
2018 Year 03 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000415

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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