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Recruitment status
Unique ID issued by UMIN UMIN000000493
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Japan East Cancer Center Breast Cancer Consortium
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000601

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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