Unique ID issued by UMIN | UMIN000001583 |
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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 |
Feasibility study of adjuvant chemotherapy consisting of FEC(fluoraouracil, epirubicin and cyclophosphamide) followed by DH(docetaxel+herceptin) for patients with HER2 positive breast cancer
Feasibility study of adjuvant chemotherapy consisting of FEC(fluoraouracil, epirubicin and cyclophosphamide) followed by DH(docetaxel+herceptin) for patients with HER2 positive breast cancer
Feasibility study of adjuvant chemotherapy consisting of FEC(fluoraouracil, epirubicin and cyclophosphamide) followed by DH(docetaxel+herceptin) for patients with HER2 positive breast cancer
Feasibility study of adjuvant chemotherapy consisting of FEC(fluoraouracil, epirubicin and cyclophosphamide) followed by DH(docetaxel+herceptin) for patients with HER2 positive breast cancer
Japan |
Breast cancer
Medicine in general | Hematology and clinical oncology | Surgery in general |
Breast surgery |
Malignancy
NO
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).
Safety
Completion rate of the treatment according with the protocol
Safety
Postponement rate as compared to planned treatment schedule
Dose reduction rate as compared to planned doses of chemotherapeutic agents
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
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.
20 | years-old | <= |
70 | years-old | > |
Female
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
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
45
1st name | |
Middle name | |
Last name | Kazuo Tamura |
Fukuoka University
The Department of Medicine, Division of Medical Oncology, Infectious Disease, and Endocrinology School of Medicine
7-45-1 Nanakuma Jonan-ku Fukuoka
092-801-1011
ktamura@fukuoka-u.ac.jp
1st name | |
Middle name | |
Last name | Kazuo Tamura |
Kyushu Breast Cancer Study Group
Executive office
1-8-17-204, Watanabe-dori, chuo-ku, Fukuoka
092-406-4166
http://www.chotsg.com
npo@chotsg.com
Kyushu Breast Cancer Study Group
Non-profit Organization Clinical Hematology/Oncology Study Group
Non profit foundation
Japan
NO
2008 | Year | 12 | Month | 17 | Day |
Unpublished
Completed
2008 | Year | 08 | Month | 01 | Day |
2008 | Year | 08 | Month | 01 | Day |
2011 | Year | 12 | Month | 01 | Day |
2008 | Year | 12 | Month | 17 | Day |
2018 | Year | 05 | Month | 14 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001771
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