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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001076
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Kinki Multidisciplinary Breast Oncology Group
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001269

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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