UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002215 |
|---|---|
| Receipt number | 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 13:35:15 |
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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
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
tishik@urahp.yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University medical center Breast and thyroid surgery
Institute
Department
Personal name
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
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® (ASCO® 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002720
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
