UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010228 |
|---|---|
| Receipt number | R000011975 |
| Scientific Title | Neoadjuvant chemotherapy with Paclitaxel/Bevacizumab followed by FEC (5-Fluorouracil/Epirubicin/Cyclophosphamide) for triple negative operable primary breast cancer |
| Date of disclosure of the study information | 2013/03/13 |
| Last modified on | 2018/08/03 11:07:45 |
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Basic information
Public title
Neoadjuvant chemotherapy with Paclitaxel/Bevacizumab followed by FEC (5-Fluorouracil/Epirubicin/Cyclophosphamide) for triple negative operable primary breast cancer
Acronym
Neoadjuvant Paclitaxel/Bevacizumab followed by FEC therapy for triple negative breast cancer
Scientific Title
Neoadjuvant chemotherapy with Paclitaxel/Bevacizumab followed by FEC (5-Fluorouracil/Epirubicin/Cyclophosphamide) for triple negative operable primary breast cancer
Scientific Title:Acronym
Neoadjuvant Paclitaxel/Bevacizumab followed by FEC therapy for triple negative breast cancer
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Response rate
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Response rate
Key secondary outcomes
Pathological complete response rate, Breast-conserving rate, Overall Survival, Relapse-free survival, Safety
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
| Medicine |
Interventions/Control_1
Neoadjuvant Paclitaxel/Bevacizumab followed by FEC (5-Fluorouracil/Epirubicin/Cyclophosphamide)
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
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Female
Key inclusion criteria
1) invasive breast cancer by needle biopsy
2) operable primary breast cancer (cStage I~IIIA)
3) ER(-), PgR(-)
4) HER2 negative (IHC 0, 1+ or FISH -)
5) P.S. = 0~1
6) measurable lesions
7) preserving the functions of bone marrow, heart, liver, and kidney
8) written informed consent
Key exclusion criteria
1) drug allergy
2) severe complications (malignant hypertension, congestive heart failure, coronary heart disease, myocardial infarction (onset within 6 months), arrhythmia (treated), infectious disease, bleeding tendency, etc)
3) feber, infection
4) peripheral neuropathy
5) pleural effusion, pericardial effusion
6) active double cancer
7) inflammatory breast cancer
8) male breast cancer
9) pregnancy
10) severe edema
11) interstitial pneumonia, fibrous lung disease
12) steroid-using patients
13) psychosomatic disease
14) active digestive ulcer
15) unsuitable patients
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koichiro Tsugawa, M.D. |
Organization
St. Marianna University School of Medicine
Division name
Department of Surgery, Division of Breast and Endocrine Surgery
Zip code
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki-city, Kanagawa, Japan
TEL
044-977-8111
koitsuga@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koiciro Tsugawa |
Organization
St. Marianna University School of Medicine
Division name
Department of Surgery, Division of Breast and Endocrine Surgery
Zip code
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki-city, Kanagawa, Japan
TEL
044-977-8111
Homepage URL
koitsuga@marianna-u.ac.jp
Sponsor or person
Institute
Department of Surgery, Division of Breast and Endocrine Surgery, St. Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Surgery, Division of Breast and Endocrine Surgery, St. Marianna University School of Medicine
Organization
Division
Category of Funding Organization
Other
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
| 2013 | Year | 03 | Month | 13 | Day |
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
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
| 2012 | Year | 10 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 03 | Month | 13 | Day |
Last follow-up date
| 2014 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 02 | Month | 28 | Day |
Date analysis concluded
| 2015 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 03 | Month | 13 | Day |
Last modified on
| 2018 | Year | 08 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011975
