UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001583
Receipt number R000001771
Scientific Title Feasibility study of adjuvant chemotherapy consisting of FEC(fluoraouracil, epirubicin and cyclophosphamide) followed by DH(docetaxel+herceptin) for patients with HER2 positive breast cancer
Date of disclosure of the study information 2008/12/17
Last modified on 2018/05/14 16:40:19

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Basic information

Public title

Feasibility study of adjuvant chemotherapy consisting of FEC(fluoraouracil, epirubicin and cyclophosphamide) followed by DH(docetaxel+herceptin) for patients with HER2 positive breast cancer

Acronym

Feasibility study of adjuvant chemotherapy consisting of FEC(fluoraouracil, epirubicin and cyclophosphamide) followed by DH(docetaxel+herceptin) for patients with HER2 positive breast cancer

Scientific Title

Feasibility study of adjuvant chemotherapy consisting of FEC(fluoraouracil, epirubicin and cyclophosphamide) followed by DH(docetaxel+herceptin) for patients with HER2 positive breast cancer

Scientific Title:Acronym

Feasibility study of adjuvant chemotherapy consisting of FEC(fluoraouracil, epirubicin and cyclophosphamide) followed by DH(docetaxel+herceptin) for patients with HER2 positive breast cancer

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

Confirmation of the treatment feasibility with 5-fuluorouracil/epirubicin/cyclophosphamide (FEC) followed by docetaxel/trastuzumab (DH) as adjuvant therapy for early breast cancer with positive HER2 protain or over-expression of HER2 gene (KBC-SG 0802).

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Completion rate of the treatment according with the protocol

Key secondary outcomes

Safety
Postponement rate as compared to planned treatment schedule
Dose reduction rate as compared to planned doses of chemotherapeutic agents


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

As FEC regimen, 5-fluorouracil 500 mg/m2 iv, epirubicine 100 mg/m2 iv and cyclophophamide 500 mg/m2 iv every 3 weeks, repeated 4 cycles

Docetaxel 75 mg/m2 iv every 3 weeks, repeated 4 cycles following FEC.
Trastuzumab beginning with a loading dose of 8 mg/kg of body weight, iv given with the first dose of Docetaxel and followed by does of 6 mg/kg iv every 3 weeks, repeated 4 cycles.

Total duration of trastuzumab will be 1 year.

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. ECOG Performance status 0-1
2. positive HER2 protain (IHC) or over-expression of HER2 gene (FISH)
3. Sufficient organ function (e.g. bone marrow, cardiac, liver and renal)
4. Primary breast cancer patients pN0-3 who underwent curative mastectomy and lymph-node dissection including negative sentinel lymph nodes
5.Within 6 weeks after surgery
6. No prior therapy including chemotherapy, radiotherapy, hormonal therapy, or immunotherapy for present primary breast cancer
7. Written informed consent

Key exclusion criteria

1. Clinical or radiological evidence of metastatic breast cancer
2. complication of the active other malignancies
3. Serious cardiac disfunction
4. Uncontrolled medical conditions
5. Significant interstitial pneumonia or pulmonary fibrosis by CT scan or X-ray
6. Patients who are required concurrent treatment by corticosteroids except for premedication
7 .Severe psychiatric disorders
8. Pregnant or lactation women, or women with suspected pregnancy
9. History of hypersensitivity reaction to drug formulated with Polysorbate 80
10. Patients judged by the investigator to be unfit to be enrolled into the study

Target sample size

45


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

092-801-1011

Email

ktamura@fukuoka-u.ac.jp


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

1-8-17-204, Watanabe-dori, chuo-ku, Fukuoka

TEL

092-406-4166

Homepage URL

http://www.chotsg.com

Email

npo@chotsg.com


Sponsor or person

Institute

Kyushu Breast Cancer Study Group

Institute

Department

Personal name



Funding Source

Organization

Non-profit Organization Clinical Hematology/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


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 01 Day

Date of IRB


Anticipated trial start date

2008 Year 08 Month 01 Day

Last follow-up date

2011 Year 12 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

2018 Year 05 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001771


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name