UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006020 |
|---|---|
| Receipt number | R000007125 |
| Scientific Title | Phase II study of EC followed by Nab-paclitaxel as Neoadjuvant Chemotherapy for Early Breast Cancer |
| Date of disclosure of the study information | 2011/07/22 |
| Last modified on | 2019/01/26 10:16:10 |
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Basic information
Public title
Phase II study of EC followed by Nab-paclitaxel as Neoadjuvant Chemotherapy for Early Breast Cancer
Acronym
Phase II study of EC followed by Nab-paclitaxel as Neoadjuvant Chemotherapy for Early Breast Cancer
Scientific Title
Phase II study of EC followed by Nab-paclitaxel as Neoadjuvant Chemotherapy for Early Breast Cancer
Scientific Title:Acronym
Phase II study of EC followed by Nab-paclitaxel as Neoadjuvant Chemotherapy for Early Breast Cancer
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the efficacy and safety of EC followed by weekly Nab-paclitaxel as neoadjuvant chemotherapy for primary breast cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
pathological complete response rate
Key secondary outcomes
adverse event
clinical response rate
pathological response rate
rate of breast-conserving surgery
feasibility
overexpression rate of SPARC
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
4 cycles of EC followed by 4 cycles of weekly nab-paclitaxel
EC
Epi-ADM 90 mg/m2 and CPA 600 mg/m2 administered intravenously on day 1 of each 3-week cycle
weekly nab-paclitaxel
nab-paclitaxel 150 mg/m2 administered weekly on days 1, 8, and, 15 of each 4-week 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
| Not applicable |
Gender
Female
Key inclusion criteria
Histologically confirmed primary breast cancer
Clinical stage T1c-3 N0/M0 or T1-3 N1/M0
At least one measurable lesion
over 20 years old
No prior surgery, radiation, chemotherapy and endocrine therapy
Adequate baseline organ function (within 14 days before registration)
Hb--over 8.0 g/dL
WBC--over 3000 /mm3 and under 12,000 /mm3
Neu--over 2,000 / mm3
Plt--over 75,000 / mm3
T-Bil--under 3 times ULM
AST/ALT--under 3 times ULN
Cre--under ULN
ECOG performance status--0-2
written informed consent
Key exclusion criteria
past medical history of drug allergy
HER2 positive breast cancer
(IHC 3+, IHC 2+ and FISH +)
Active double cancer
Severe complications
Symptomatic brain metastasis
Severe mental disorder
History of blood transfusions within 2 weeks
Sever bone marrow suppression, renal dysfunction, liver dysfunction
Body cavity fluid
watery diarrhea on registration
Active infection or potentiality infection
allergic reaction of the nab-paclitaxel, paclitaxel or albumin
During pregnancy or lactation
Judged by the investigator to be unfit to be enrolled into the study
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuhiro Suzuki |
Organization
Tokai University School of Medicine
Division name
Division of Breast and Endocrine Surgery, Department of Surgery
Zip code
Address
143 Shimokasuya, Isehara-shi, Kanagawa, Japan 259-1193
TEL
+81-463-93-1121
luke-szk@is.icc.u-tokai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuhiro Suzuki |
Organization
Tokai University School of Medicine
Division name
Division of Breast and Endocrine Surgery, Department of Surgery
Zip code
Address
143 Shimokasuya, Isehara city, Kanagawa, Japan, 259-1193
TEL
+81-463-93-1121
Homepage URL
luke-szk@is.icc.u-tokai.ac.jp
Sponsor or person
Institute
Tokai University School of Medicine
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
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
| 2011 | Year | 07 | Month | 22 | 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
Terminated
Date of protocol fixation
| 2011 | Year | 07 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 08 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 07 | Month | 22 | Day |
Last modified on
| 2019 | Year | 01 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007125
