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Recruitment status Main results already published
Unique ID issued by UMIN UMIN000002215
Receipt No. R000002720
Scientific Title Randomized phase II study with six cycles of Docetaxel/cyclophosphamide (TC) and 5-fluorouracil, epirubicin, and cyclophosphamide (FEC100) followed by docetaxel for treating hormone receptor-negative breast cancers
Date of disclosure of the study information 2009/07/17
Last modified on 2019/07/16

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Basic information
Public title Randomized phase II study with six cycles of Docetaxel/cyclophosphamide (TC) and 5-fluorouracil, epirubicin, and cyclophosphamide (FEC100) followed by docetaxel for treating hormone receptor-negative breast cancers
Acronym Randomized phase II study with TC and FEC-DOC
Scientific Title Randomized phase II study with six cycles of Docetaxel/cyclophosphamide (TC) and 5-fluorouracil, epirubicin, and cyclophosphamide (FEC100) followed by docetaxel for treating hormone receptor-negative breast cancers
Scientific Title:Acronym Randomized phase II study with TC and FEC-DOC
Region
Japan

Condition
Condition Breast cancer
Classification by specialty
Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study was to compare the benefit of 6 cycles of docetaxel and cyclophosphamide (TC) and 3 cycles of 5-fluorouracil, epirubicin, and cyclophosphamide followed by 3 cycles of docetaxel (FEC-DOC) in the neoadjuvant treatment of operative hormone-negative breast cancer. The primary end point was the rate of pathological response. The secondary end point was safety of these regimens. This study also analyzed tumor biopsies for predictive factors of these regimens.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes histological effect
Key secondary outcomes Safety
Breast conservation rate
Recurrence-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 YES
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 FEC-DOC Group: 5-FU 500mg/m2 iv day1
Epirubicin 100mg/ m2/day 1
Cyclophosphamide 500mg/m2 iv day1
Every 21 days for 3 cycles, then
Docetaxel 100 mg/m2 iv day1
Every 21 days for 3 cycles
After completing treatment, surgical operation is performed.
Interventions/Control_2 Cyclophosphamide 600mg/m2 iv day1
Docetaxel 75mg/m2 iv day1
Every 21 days for 6 cycles.
After completing treatment, surgical operation is performed.

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) Invasive breast cancer proven histologically
2) Hormone receptor-negative and without distant metastasis
3)No history of surgery, radiotherapy, hormonal therapy against breast cancer
4)ECOG Performance Status(P.S.) 0-2
5)measurable lesion
6)Sufficient organ function (e.g. bone marrow, cardiac, liver and renal) laboratory parameters
WBC >=4,000, <12,000/mm3
or Neutrophil >=2,000
Platelet >=100,000/mm3
Hemoglobin >=9.5g/dl
AST and ALT <=1.5x upper limit of
normal
Total bilirubin <=1.25x upper limit of normal
Serum creatinine <=1.5x upper limit of normal
7)Age >=20 to <80 years
8)Written informed consent
Key exclusion criteria 1)A history of hypersensitivity reaction to any drugs.
2)seriously compromised
3)Suspected of infection with fever
4)peripheral neuropathy
5)Treatment required pleural or pericardial effusions
6)complication of the active other malignancies
7)Inflammatory breast cancer
8)Male
9)Pregnant or lactation women, or women with suspected pregnancy
10)edema
11)Symptomatic varicella
12) Significant interstitial pneumonia or pulmonary fibrosis by CT scan or X-ray
13) Patients who are required concurrent treatment by corticosteroids except for premedication
14)psychological disorders
15) Patients judged by the investigator to be unfit to be enrolled into the study
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Ishikawa
Organization Yokohama City University Medical Center
Division name Breast and thyroid surgery
Zip code
Address 4-57, Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL 045-261-5656
Email tishik@urahp.yokohama-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Ishikawa
Organization Yokohama City University Medical Center
Division name Breast and thyroid surgery
Zip code
Address 4-57, Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL 045-261-5656
Homepage URL
Email tishik@urahp.yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University medical center Breast and thyroid surgery
Institute
Department

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
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
2009 Year 07 Month 17 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Main results already published
Date of protocol fixation
2009 Year 02 Month 03 Day
Date of IRB
2008 Year 11 Month 20 Day
Anticipated trial start date
2009 Year 02 Month 01 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information 2013 Annual Meeting of the American Society of Clinical Oncology&reg; (ASCO&reg; 2013)
JCO 31, 2013 (suppl; abstr 1047)

Management information
Registered date
2009 Year 07 Month 16 Day
Last modified on
2019 Year 07 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002720

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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