UMIN-CTR Clinical Trial

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
Last 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
1st 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/icdr_e/ctr_view.cgi?recptno=R000001269