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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000001736 |
Receipt No. | R000002019 |
Scientific Title | Neo-adjuvant therapy with paclitaxel followed by FEC fluoraouracil, epirubicin and cyclophosphamide) for primary breast cancer(KBC-SG0801) |
Date of disclosure of the study information | 2009/02/27 |
Last modified on | 2018/05/14 |
Basic information | ||
Public title | Neo-adjuvant therapy with paclitaxel followed by FEC fluoraouracil, epirubicin and cyclophosphamide) for primary breast cancer(KBC-SG0801) | |
Acronym | Neo-adjuvant therapy with paclitaxel followed by FEC fluoraouracil, epirubicin and cyclophosphamide) for primary breast cancer(KBC-SG0801) | |
Scientific Title | Neo-adjuvant therapy with paclitaxel followed by FEC fluoraouracil, epirubicin and cyclophosphamide) for primary breast cancer(KBC-SG0801) | |
Scientific Title:Acronym | Neo-adjuvant therapy with paclitaxel followed by FEC fluoraouracil, epirubicin and cyclophosphamide) for primary breast cancer(KBC-SG0801) | |
Region |
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Condition | ||||
Condition | Primary breast cancer | |||
Classification by specialty |
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Classification by malignancy | Malignancy | |||
Genomic information | NO |
Objectives | |
Narrative objectives1 | Clinical & pathological response and safety profile of neoadjuvant chemotherapy consisting of sequential treatment with paclitaxel monotherapy followed by FEC regimen for patients with primary breast cancer. |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Confirmatory |
Trial characteristics_2 | Pragmatic |
Developmental phase |
Assessment | |
Primary outcomes | Pathological complete response rate |
Key secondary outcomes | Safety
Clinical efficacy Overall survival Disease free survival Breast-conserving rate |
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 | Paclitaxel 80mg/m2 every week for 12 cycles.
5-FU 500mg/m2, Epirubicin 100mg/m2, Cyclophosphamide 500mg/m2 on day 1, every 3 weeks for 4 cycles. Operation is to be offered to the patients with breast cancer as a curative intent within 2 months after neoadjuvant chemotherapy. |
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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.Histologicaly-proven primary resectable breast cancer with a tumor size of >=1cm and clinical stage of <=IIIA
2. No history of chemotherapy 3. No history of surgery, radiotherapy, hormonal therapy against breast cancer 4. ECOG PS 0, 1 5. Sufficient organ function 6. Written informed consent |
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Key exclusion criteria | 1. Severe medical conditions
2. Suspected infectious disease 3. Alergy to clemohol EL 4. Severe peripheral neuropathy 5. Pregnant or lactating women |
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Target sample size | 32 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Kurume Daiichi Social Insurance Hospital | ||||||
Division name | Surgery | ||||||
Zip code | |||||||
Address | 21 Kushihara-Cho, Kurume | ||||||
TEL | 0942-33-1211 | ||||||
maki@tanaka.name |
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 | |
Address | |
Tel | |
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 | 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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
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=R000002019 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |