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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | C000000291 |
Receipt No. | R000000368 |
Scientific Title | Study of Docetaxel followed by FEC as primary systemic chemotherapy for operable breast cancer (JBCRG-03) |
Date of disclosure of the study information | 2005/11/25 |
Last modified on | 2019/11/21 |
Basic information | ||
Public title | Study of Docetaxel followed by FEC as primary systemic chemotherapy for operable breast cancer (JBCRG-03) | |
Acronym | JBCRG-03(DOC-FEC as primary systemic chemotherapy) | |
Scientific Title | Study of Docetaxel followed by FEC as primary systemic chemotherapy for operable breast cancer (JBCRG-03) | |
Scientific Title:Acronym | JBCRG-03(DOC-FEC as primary systemic chemotherapy) | |
Region |
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Condition | |||
Condition | Operable breast cancer | ||
Classification by specialty |
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Classification by malignancy | Malignancy | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | To evaluate the effectg and safety of Docetaxel followed by FEC as primary systemic chmeotehrapy |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Confirmatory |
Trial characteristics_2 | |
Developmental phase | Phase II |
Assessment | |
Primary outcomes | Pathological responce, safety |
Key secondary outcomes | Clinical response, Breast conserving rate, Overall survival, 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 |
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Interventions/Control_1 | Chemotherapy | |
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 | T1c-3N0M0, T1-3N1M0
No previous treatment for breast cancer Adequate organ function Written informed consent |
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Key exclusion criteria | Drug hypersensitivity
Severe complication Inflammatory breast cancer Double cancer Bilateral breast cancer |
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Target sample size | 130 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Aichi Cancer Center Hospital
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Division name | Department of Breast Oncology | ||||||
Zip code | 464-8681 | ||||||
Address | 1-1 Kanokoden, Chikusa-ku, Nagoya 464-8681, Japan | ||||||
TEL | 052-762-6111 | ||||||
hiwata@aichi-cc.jp |
Public contact | |||||||
Name of contact person |
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Organization | JBCRG | ||||||
Division name | Head office | ||||||
Zip code | 103-0016 | ||||||
Address | 9-4-3F, Nihonbashikoamicho, Chuo-ku, Tokyo 103-0016, Japan | ||||||
TEL | 03-6264-8873 | ||||||
Homepage URL | |||||||
office@jbcrg.jp |
Sponsor | |
Institute | Japan Breast Cancer Research Group (JBCRG) |
Institute | |
Department |
Funding Source | |
Organization | Advanced Clinical Reseach Orginization (ACRO) |
Organization | |
Division | |
Category of Funding Organization | Self funding |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | JBCRG |
Address | 9-4-3F, Nihonbashikoamicho, Chuo-ku, Tokyo 103-0016, Japan |
Tel | 03-6264-8873 |
office@jbcrg.jp |
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 | Published |
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 |
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Date trial data considered complete |
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Date analysis concluded |
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Other | |
Other related information | Presentations:The 15th Annual Meeting of the Japanese Breast Cancer Society(2007),The 16th Annual Meeting of the Japanese Breast Cancer Society(2008), 6hth EBCC
Papers:Biomed Pharmacother (2005,Oct; 59 Suppl 2:S387-92), BIG News Letter (2006, 8(1), Breast Cancer (2006,13(1), p38-48), JJBC(2007, 22(5), p372-375), European J of Cancer Suppl.(2008,16(7), p121),Japanese Journal of Clinical Oncology(2011, 41: 867-875) |
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=R000000368 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |