UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001076 |
|---|---|
| Receipt number | R000001269 |
| Scientific Title | Docetaxel plus cyclophophamide as adjuvant chemotherapy for negative axillary lymph node breast cancer |
| Date of disclosure of the study information | 2008/03/13 |
| Last modified on | 2019/03/22 16:09:08 |
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Basic information
Public title
Docetaxel plus cyclophophamide as adjuvant chemotherapy for negative axillary lymph node breast cancer
Acronym
Docetaxel plus cyclophophamide as adjuvant chemotherapy for negative axillary lymph node breast cancer
Scientific Title
Docetaxel plus cyclophophamide as adjuvant chemotherapy for negative axillary lymph node breast cancer
Scientific Title:Acronym
Docetaxel plus cyclophophamide as adjuvant chemotherapy for negative axillary lymph node breast cancer
Region
| Japan |
Condition
Condition
Breast Cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the feasibility of docetaxel plus cyclophosphamide chemotherapy for node negative breast cancer patients with intermdediate risk of recurrence.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Planned treatment completion rate
Key secondary outcomes
Toxicity,
Mean delivered treatment course,
Relative dose-intensity
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 600mg/m2, IV, Day 1
Every 21 days for 6 cycles
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
| Not applicable |
Age-upper limit
| 70 | years-old | >= |
Gender
Female
Key inclusion criteria
Patients who have received any prior therapy (hormonal therapy, chemotherapy, etc.)
Pregnant or lactation women
History of hypersensitivity reaction to drugs formulated with polysorbate
Distant metastasis
Patients judged by the investigator to be unfit to be enrolled into the study
Key exclusion criteria
Histologically proven female breast cancer who underwent complete surgical excision
No incidence of axillary metastasis by lymph node dissection or sentinel node biopsy
Age >= 20 to =<34 or >=35 to =<70 who fills one of the followings (St.Gallen category of node-negative with intermediate risk)
Tumor size >2cm
Histologic and / or nuclear grade2-3
Presence of peritumoral vascular invasion
HER2 IHC (3+) or FISH (+)
ER (-)
ECOG PS 0-1
No more than 2 weeks from the lastsurgery
Patients were required to have
leukocyte >= 4000/mm3 or neutrophil >= 2000/mm3
hemoglobin >= 10 g/dL
platelet count >= 100,000/ mm3
total bilirubin =< 1.5 mg/dL
AST =< 2.5x the upper limit of normal
serum creatinine less than 1.5 mg/dL
Sufficient organ function
Written informed consent
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Norikazu Masuda |
Organization
Osaka Medical Center
Division name
Surgery
Zip code
Address
2-1-14 Hoenzaka, Chuo-ku, Osaka, JAPAN 540-0006
TEL
06-6942-1331
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Norikazu Masuda |
Organization
Kinki Multidisciplinary Breast Oncology Group
Division name
Secretariat office
Zip code
Address
Osaka National Hospital, Department of Surgery
TEL
06-6942-1331
Homepage URL
Sponsor or person
Institute
Kinki Multidisciplinary Breast Oncology Group
Institute
Department
Personal name
Funding Source
Organization
Sakai Clinical Research Supporting Center(SCRSC)
Organization
Division
Category of Funding Organization
Non profit foundation
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
| 2008 | Year | 03 | Month | 13 | 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
Completed
Date of protocol fixation
| 2006 | Year | 06 | Month | 09 | Day |
Date of IRB
| 2006 | Year | 06 | Month | 30 | Day |
Anticipated trial start date
| 2006 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2008 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1) Jones SE, Savin MA, Holmes FA, et al. Finalanalysis:TC(docetaxel/cyclophosphamide, 4 cycles) has a superior disease-free survival compared to standard AC (doxorubicin/cyclophosphamide) in 1016 women with early stage breast cancer. Breast Cancer Res Treat 94 (Suppl 1): S20, 2005 (Abstract No: 0040)
Management information
Registered date
| 2008 | Year | 03 | Month | 13 | Day |
Last modified on
| 2019 | Year | 03 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001269
