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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000001583 |
Receipt No. | 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 |
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 |
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Condition | |||||
Condition | Breast cancer | ||||
Classification by specialty |
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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).
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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 |
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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. |
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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 |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 45 |
Research contact person | |||||||
Name of lead principal investigator |
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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 | ||||||
ktamura@fukuoka-u.ac.jp |
Public contact | |||||||
Name of contact person |
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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 | ||||||
npo@chotsg.com |
Sponsor | |
Institute | Kyushu Breast Cancer Study Group |
Institute | |
Department |
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 | |
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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 |
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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 | |
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Baseline Characteristics | |
Participant flow | |
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Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
Date of protocol fixation |
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Anticipated trial start date |
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Last follow-up date |
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Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.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 |