UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017382 |
|---|---|
| Receipt number | R000020170 |
| Scientific Title | A Phase II trial of nab-paclitaxel followed by EC as neoadjuvant chemotherapy for resectable breast cancer. |
| Date of disclosure of the study information | 2015/05/01 |
| Last modified on | 2015/05/01 19:45:32 |
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Basic information
Public title
A Phase II trial of nab-paclitaxel followed by EC as neoadjuvant chemotherapy for resectable breast cancer.
Acronym
Neo-ABEC trial
Scientific Title
A Phase II trial of nab-paclitaxel followed by EC as neoadjuvant chemotherapy for resectable breast cancer.
Scientific Title:Acronym
Neo-ABEC trial
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and safety of tri-weekly nab-paclitaxel followed by EC for resectable breast cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Pathological Complete Response Rate
Key secondary outcomes
Overall response rate
Safety
Breast conservation rate
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
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Triweekly nab-paclitaxel followed by EC as Neoadjuvant chemotherapy.Nab-paclitaxel regimen 260mg/m2 iv day 1
Q3weeks of each 4 cycles.EC regimen Epirubicin 90mg/m2 iv day 1.Cyclophosphamide 600mg/m2 iv day 1 Q3weeks of each 4 cycle.
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
Female resectable breast cancer (T1c-3N0-2M0)
Histologically confirmed invasive breast cancer by biopsy.Evaluated ER and PgR status by IHC.
Evaluated ER and PgR status by FISH.20 to 79 years old at diagnosis.
Adequate major organ function.
LVEF > 50% (by MUGA or ECHO).QTc < 470mec (by ECG).
Performance status(ECOG) should be 0 or 1. Written informed consent.
Key exclusion criteria
History of drug-hypersensitivity.
No previous treatments for breast cancer (within 5 years) .
Active double cancer.
Synchronous bilateral breast cancer excluding contralateral non-invasive cancer (DCIS/LCIS).
Male patient.
Infection or suspected infection.
Serious cardiac disorder or preexisting cardiac disease.
Uncontrolled diabetes.
Gastrointestinal ulceration or gastrointestinal bleeding
Current pregnancy and lactation, or possibility of pregnancy.
Ineligible based on decision of an investigator.
preexisting cardiac disease.
Uncontrolled diabetes.
Gastrointestinal ulceration or gastrointestinal bleeding.
Current pregnancy and lactation, or possibility of pregnancy.
Ineligible based on decision of an investigator.
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takahiro Okamoto |
Organization
Tokyo Women's Medical University
Division name
Department of Endocrine Surgery
Zip code
Address
8-1, Kawadachou, Shinjuku-ku, Tokyo, Japan.
TEL
+81-3-3353-8111
akko-s@mth.biglobe.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akiko Sakamoto |
Organization
Tokyo Women's Medical University
Division name
Department of Endocrine Surgery
Zip code
Address
8-1, Kawadachou, Shinjuku-ku, Tokyo, Japan.
TEL
+81-3-3353-8
Homepage URL
akko-s@mth.biglobe.ne.jp
Sponsor or person
Institute
Tokyo Women's Medical University,Department of endocrine surgery
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
None
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
東京女子医科大学病院(東京都）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 05 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2018 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2018 | Year | 10 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 05 | Month | 01 | Day |
Last modified on
| 2015 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020170
