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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | No longer recruiting |
Unique ID issued by UMIN | UMIN000017675 |
Receipt No. | R000020489 |
Scientific Title | A study of neoadjuvant nab-paclitaxel followed by FEC for luminal B-like (HER2-negative) and triple-negative breast cancer |
Date of disclosure of the study information | 2015/05/25 |
Last modified on | 2018/01/05 |
Basic information | ||
Public title | A study of neoadjuvant nab-paclitaxel followed by FEC for luminal B-like (HER2-negative) and triple-negative breast cancer | |
Acronym | A study of neoadjuvant nab-paclitaxel followed by FEC for HER2-negative breast cancer | |
Scientific Title | A study of neoadjuvant nab-paclitaxel followed by FEC for luminal B-like (HER2-negative) and triple-negative breast cancer | |
Scientific Title:Acronym | A study of neoadjuvant nab-paclitaxel followed by FEC for HER2-negative breast cancer | |
Region |
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Condition | ||
Condition | Luminal B-like (HER2-negative) or triple-negative operable breast cancer | |
Classification by specialty |
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Classification by malignancy | Malignancy | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | The aim of this study is to investigate the efficacy of neoadjuvant nab-paclitaxel followed by FEC and is to fined predictive markers for neoadjuvant chemotherapy and predictive factor for patients after neoadjuvant chemotherapy |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Exploratory |
Trial characteristics_2 | |
Developmental phase | Phase II |
Assessment | |
Primary outcomes | Pathological complete response rate based on subtype |
Key secondary outcomes | Breast conserving rates, response rates, safety, disease-free survival, overall survival, response rates of nab-paclitaxel,safety of nab-paclitaxel and identification of predictive factors for neoadjuvant chemotherapy and prognostic factors for patients after neoajuvant chemotherapy |
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 | Four cycles of nab-paclitaxel 260 mg/m2 every 3 weeks followed by 4 cycles of FEC (5-FU 500 mg/m2, Epirubicin 100 mg/m2, cyclophosphamide 500 mg/m2) every 3 weeks | |
Interventions/Control_2 | ||
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Interventions/Control_7 | ||
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Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Female | |||
Key inclusion criteria | 1) Pathologically confirmed breast cancer
2) Clinical T1-3, N0-2, M0 and operable breast cancer after neoadjuvant chemotherapy 3) Luminal B-like(HER2-negative) or Triple-negative breast cancer 4) 20 years old and more than 20 years old, and less than 70 years old 5) mesurable disease (RECIST ver 1.1) 6) No any previous treatment for breast cancer 7) Performance status 0-1 8) keeping majour organ function with all condition below within 2 weeks before enrollment WBC, > 4000/mm3 and < 12,000 Neutropil, > 2000/mm3 platelets, > 100,000/mm3 Hb 10.0 g/dl ALT and AST, within 2x UNL T-bil, < 1.5 mg/dl Cr, < 1.5 mg/dl ECG, within normal limit (no severe arrythmia) UCG and MUGA scan, LVEF < 55% 9) indication for neoajuvant chemotherapy 10) Submission of needle biopsy sample before treatment and surgical specimen after neoajuvant chemotherapy and written informed consent |
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Key exclusion criteria | 1) clinically important cardiac disorder and past history of this
2) Severe medical disorders (uncontrolled DM, hypertension, renal failure, liver failure, clinically significant infection and mental disorders) 3) pregnant and nursing female 4) active double cancer 5) lung fibrosis and intestinal pneumonisa 6) allergy reaction for drugs is using in this study 7) Others |
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Target sample size | 94 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Graduate shool of medical sciences, Kumamoto University | ||||||
Division name | Department of Breast and Endocrine Surgery | ||||||
Zip code | |||||||
Address | 1-1-1, Chuo-ku, , Kumamoto,860-8556, Japan | ||||||
TEL | 81-96-373-5521 | ||||||
ys-yama@triton.ocn.ne.jp |
Public contact | |||||||
Name of contact person |
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Organization | Clinical Hematology Oncology Treatment Study Group | ||||||
Division name | Kyushu Breast Cancer Study Group | ||||||
Zip code | |||||||
Address | 1-8-17-204, Watanabe douri, Chuo-ku, Fukuoka, 810-0004, Japan | ||||||
TEL | 81-92-406-4166 | ||||||
Homepage URL | http://www.chotsg.com/kbc-sg/index.html | ||||||
kbc@chotsg.com |
Sponsor | |
Institute | Kyushu Breast Cancer Study Group (KBC-SG) |
Institute | |
Department |
Funding Source | |
Organization | Kyushu Breast Cancer Study Group (KBC-SG) |
Organization | |
Division | |
Category of Funding Organization | Self funding |
Nationality of Funding Organization |
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IRB Contact (For public release) | |
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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 | 熊本大学医学部附属病院等 |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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Baseline Characteristics | |
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IPD sharing Plan description |
Progress | |||||||
Recruitment status | No longer recruiting | ||||||
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Management information | |||||||
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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=R000020489 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |