UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000493 |
|---|---|
| Receipt number | R000000601 |
| Scientific Title | A Phase II study of docetaxel (T) and cyclophosphamide(C) as adjuvant chemotherapy for patients with high risk, node negative, early stage breast cancer |
| Date of disclosure of the study information | 2006/10/01 |
| Last modified on | 2006/09/27 16:52:54 |
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Basic information
Public title
A Phase II study of docetaxel (T) and cyclophosphamide(C) as adjuvant chemotherapy for patients with high risk, node negative, early stage breast cancer
Acronym
JECBC04
Scientific Title
A Phase II study of docetaxel (T) and cyclophosphamide(C) as adjuvant chemotherapy for patients with high risk, node negative, early stage breast cancer
Scientific Title:Acronym
JECBC04
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Endocrine surgery | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Feasibility as determined by the percentage of patients who can complete 4 cycles of chemotherapy with more than 1 dose reduction
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Safety, feasibility
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Docetaxel 75 mg/m2 IV Day 1 Cyclophosphamide 600 mg/m2 IV Day 1 Every 21 days X 4 Cycles Use standard premedication
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
| 70 | years-old | >= |
Gender
Female
Key inclusion criteria
Patients with Stage I, II, or operable Stage III invasive breast cancer
Node negative early stage breast cancer (T1-4, N0, M0)
High risk node negative patients will be defined as patients with negative (N0) lymph node involvement , and at least 1 of the following factors :
Tumor size >2cm2
Histologic and / or nuclear grade2-3
Age <35 years
Presence of peritumoral vascular invasion
HER2 / neu gene overexpressed or amplified
Estrogen receptor and progesterone receptor status negative
Complete surgical excision of the primary tumor
Age >20 years and < 70 years
ECOG performance status 0-1
No more than 12 weeks after most recent surgery
Signed informed consent
Sufficient organ function
Key exclusion criteria
Male
A history of other malignancies within the last 5 years except for adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix
Bilateral breast cancer
Inflammatory breast cancer
A history of hypersensitivity reaction to drugs formulated with Polysorbate 80
Uncontrolled medical conditions (e.g., malignant hypertension, congestive heart failure, renal failure, myocardial infarction in the previous 6 months, treatment required arrhythmia, infection, hemorrhage)
Grade 2-4 peripheral neuropathy
Pleural or pericardial effusion requiring treatment
Severe peripheral edema.
Significant interstitial pneumonia or pulmonary fibrosis by CT scan or X-ray
Patients who require concurrent treatment by corticosteroids except for premedication.
Evere psychiatric disorders
Pregnant or lactating women
Patients judged by the investigator to be unfit to be enrolled into the study
Prior chemotherapy or radiation therapy for other cancer within 3 years including neo-adjuvant chemotherapy for locally advanced breast cancer.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshio Tabei |
Organization
JECBC
Division name
Saitama Cancer Center
Zip code
Address
818 Komuro, Ina-machi, Kitaadachi-gun, Saitama
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshio Tabei |
Organization
JECBC
Division name
Saitama Cancer Center
Zip code
Address
818 Komuro, Ina-machi, Kitaadachi-gun, Saitama
TEL
Homepage URL
Sponsor or person
Institute
Japan East Cancer Center Breast Cancer Consortium
Institute
Department
Personal name
Funding Source
Organization
Advanced Clinical Research Organization
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
| 2006 | Year | 10 | Month | 01 | 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
Date of protocol fixation
| 2006 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2007 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2006 | Year | 09 | Month | 27 | Day |
Last modified on
| 2006 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000601
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