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

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 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


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

Value
https://center6.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