UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001582
Receipt number R000001768
Scientific Title Feasibility study of TC(docetaxel+Cyclophosphamide)as adjuvant chemotherapy for intermediate risk primary breast cancer with HER2-negative and ER-positive tumor(KBC-SG 0803)
Date of disclosure of the study information 2008/12/17
Last modified on 2010/08/04 15:19:45

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Basic information

Public title

Feasibility study of TC(docetaxel+Cyclophosphamide)as adjuvant chemotherapy for intermediate risk primary breast cancer with HER2-negative and ER-positive tumor(KBC-SG 0803)

Acronym

Feasibility study of TC (docetaxel+cyclophosphamide) as adjuvant chemotherapy for intermediate risk primary breast cancer with HER2-negative and ER-positive tumor (KBC-SG 0803)

Scientific Title

Feasibility study of TC(docetaxel+Cyclophosphamide)as adjuvant chemotherapy for intermediate risk primary breast cancer with HER2-negative and ER-positive tumor(KBC-SG 0803)

Scientific Title:Acronym

Feasibility study of TC (docetaxel+cyclophosphamide) as adjuvant chemotherapy for intermediate risk primary breast cancer with HER2-negative and ER-positive tumor (KBC-SG 0803)

Region

Japan


Condition

Condition

Breast cancer

Classification by specialty

Medicine in general Hematology and clinical oncology Surgery in general
Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Evaluation of the completion rate for 4 cycles of adjuvant chemothrapy as docetaxel plus cyclophosphamide (TC) regimen for patients who will have an intermediate risk primary breast cancer with HER2-negtive and ER-positive.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

completion rate

Key secondary outcomes

safety, disease-free survival


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

4 cycles of TC (Docetaxel 75 mg/m2 / Cyclophosphamide 600mg/m2), every 3 weeks

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

1.Primary breast cancer patients with negative HER2 excluded HER2 3+ by IHC3 or positive by FISH,and ER positive breast dancer.
Intermediate risk for recurrence according to the classification proposed by the 10th International Symposium on Primary Therapy of Breast Cancer (St.Gallen, 2007)
2.ECOG Performance status 0-1
3.Within 6 weeks after surgery
4.No prior therapy including chemotherapy, radiotherapy, hormonal therapy, or immunotherapy for present primary breast cancer
5.Sufficient organ function (e.g. bone marrow, cardiac, liver and renal)
6.Written informed consent

Key exclusion criteria

1.History of bilateral breast cancer
2.History of other malignancies within the last 5 years except for adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix
3.Inflammatory breast cancer
4.Male
5.A history of hypersensitivity reaction to any drugs.
6.Uncontrolled medical conditions.
7.Suspected of infection with fever
8.Severe peripheral neuropathy (>grade 1)
9.Symptomatic varicella.
10.HBs antigen positive
11.Treatment required pleural or pericardial effusions
12.Severe peripheral edema (>grade 1)
13.Significant interstitial pneumonia or pulmonary fibrosis by CT scan or X-ray
14.Patients who are required concurrent treatment by corticosteroids except for premedication
15.Severe psychiatric disorders
16.Pregnant or lactation women, or women with suspected pregnancy
17.Patients judged by the investigator to be unfit to be enrolled into the study

Target sample size

102


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazuo Tamura

Organization

Fukuoka University

Division name

The Department of Medicine, Division of Medical Oncology,Infectious Disease, and Endocrinology School of Medicine

Zip code


Address

7-45-1 Nanakuma Jonan-ku Fukuoka

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name Kazuo Tamura

Organization

Kyushu Breast Cancer Study Group

Division name

Executive office

Zip code


Address

7-45-1 Nanakuma Jonan-ku Fukuoka

TEL

092-801-2845

Homepage URL

http://www.chotsg.com

Email



Sponsor or person

Institute

Kyushu Breast Cancer Study Group

Institute

Department

Personal name



Funding Source

Organization

Non-profit Organization Clinical Henmatology/Oncology Study Group

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 12 Month 17 Day


Related information

URL releasing protocol

http://www.chotsg.com

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

2008 Year 08 Month 07 Day

Date of IRB


Anticipated trial start date

2008 Year 08 Month 01 Day

Last follow-up date

2015 Year 07 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

2008 Year 12 Month 17 Day

Last modified on

2010 Year 08 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001768


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name