UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006053 |
|---|---|
| Receipt number | R000007162 |
| Scientific Title | Phase II study of weekly Nab-paclitaxel followed by FEC as Neoadjuvant Chemotherapy for Early Breast Cancer |
| Date of disclosure of the study information | 2011/07/28 |
| Last modified on | 2023/08/07 09:15:01 |
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Basic information
Public title
Phase II study of weekly Nab-paclitaxel followed by FEC as Neoadjuvant Chemotherapy for Early Breast Cancer
Acronym
Phase II study of weekly Nab-paclitaxel followed by FEC as Neoadjuvant Chemotherapy for Early Breast Cancer
Scientific Title
Phase II study of weekly Nab-paclitaxel followed by FEC as Neoadjuvant Chemotherapy for Early Breast Cancer
Scientific Title:Acronym
Phase II study of weekly Nab-paclitaxel followed by FEC 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 Nab-paclitaxel followed by FEC 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
clinical response rate
rate of breast-conserving surgery
adverse event
feasibility
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
Neo-adjyuvant chemotherapy as 12 weeks of nab Paclitaxel followed by 4 cycles of FEC
weekly nab-paclitaxel:nab-paclitaxel 100 mg/m2 administered weekly on days 1, 8, and, 15 of 4-week cycle, Trastuzumab will be cocurrently administered during nab-Paclitaxel treatment for HER2 positive cases
FEC: Epi-ADM 100 mg/m2, 5FU 500mg/m2 and CPA 600 mg/m2 administered intravenously on day 1 of 3-week
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
1.Histologically confirmed primary breast cancer
2.Clinical stage T1N1M0 or T2-3N0-2M0
3.No prior surgery, radiation, chemotherapy and endocrine therapy
4.At least one measurable lesion
5.ECOG performance status 0-2
6.Adequate baseline organ function
7.Adequate cardiac function
8.written informed consent
Key exclusion criteria
1.Severe complications
2.past medical history of severe drug allergy
3.allergic reaction of the nab-paclitaxel, paclitaxel or albumin
4.active double cancer
5.inflammatory breast cancer
6.during pregnancy or breast feeding 7.severe peripheral neuropathy
8.interstitial pneumonaitis
9.serious body cavity fluid
10.HBsAf+ or HCVAb+
11.Judged by the investigator to be unfit to be enrolled into the study
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Hiroko |
| Middle name | |
| Last name | Bando |
Organization
University of Tsukuba
Division name
Breast and Endocrine Surgery
Zip code
3058576
Address
1-1-1 Tennodai, Tsukuba, Ibaraki
TEL
029-853-3210
bando@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Hiroko |
| Middle name | |
| Last name | Bando |
Organization
University of Tsukuba
Division name
Breast and Endocrine Surgery
Zip code
3058576
Address
1-1-1 Tennodai, Tsukuba, Ibaraki
TEL
0298533341
Homepage URL
bando@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
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
TCREDO
Address
2-1-1 Amakubo Tsukuba Ibaraki
Tel
029-853-3914
rinshokenkyu@un.tsukuba.ac.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
筑波大学附属病院
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 07 | Month | 28 | Day |
Related information
URL releasing protocol
https://www.md.tsukuba.ac.jp/clinical-med/bte-surg/
Publication of results
Unpublished
Result
URL related to results and publications
https://www.md.tsukuba.ac.jp/clinical-med/bte-surg/
Number of participants that the trial has enrolled
35
Results
35 cases are enrolled. There was no SAE. Efficacy and safety was considered to be almost equal to standard treatment.
Results date posted
| 2023 | Year | 08 | Month | 07 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
35 female with operable breast cancer.
Participant flow
Written Informed consent was obtained.
Adverse events
none
Outcome measures
Response rate
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2011 | Year | 07 | Month | 13 | Day |
Date of IRB
| 2011 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2011 | Year | 09 | Month | 02 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 07 | Month | 27 | Day |
Last modified on
| 2023 | Year | 08 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007162
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| Registered date | File name |
| Research case data | |
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