UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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)
Title of the study (Brief title)	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	Shinji Ohno
Organization	The Cancer Institute Hospital Of JFCR (moved from National Hospital Organization Kyushu Cancer Center)
Division name	Breast Oncology Center
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	Shinji Ohno
Organization	The Cancer Institute Hospital Of JFCR (moved from National Hospital Organization Kyushu Cancer Cente
Division name	Breast Oncology Center
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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2005 Year 12 Month 14 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000000415