UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013513 |
|---|---|
| Receipt number | R000007653 |
| Scientific Title | Phase 2 clinical trial of primary systemic therapy for primary breast cancer Sequential regimen of Nab-Paclitaxel followed by EC for HER2 negative breast cancer and concurrent regimen of Docetaxel/Carboplatin/Herceptin for HER2 positive breast cancer |
| Date of disclosure of the study information | 2014/03/25 |
| Last modified on | 2014/03/25 19:58:36 |
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Basic information
Public title
Phase 2 clinical trial of primary systemic therapy for primary breast cancer
Sequential regimen of Nab-Paclitaxel followed by EC for HER2 negative breast cancer and concurrent regimen of Docetaxel/Carboplatin/Herceptin for HER2 positive breast cancer
Acronym
Phase 2 clinical trial of primary systemic therapy for breast cancer
Nab-Paclitaxel followed by EC for HER2- breast cancer and Docetaxel/Carboplatin/Herceptin for HER2+ breast cancer
Scientific Title
Phase 2 clinical trial of primary systemic therapy for primary breast cancer
Sequential regimen of Nab-Paclitaxel followed by EC for HER2 negative breast cancer and concurrent regimen of Docetaxel/Carboplatin/Herceptin for HER2 positive breast cancer
Scientific Title:Acronym
Phase 2 clinical trial of primary systemic therapy for breast cancer
Nab-Paclitaxel followed by EC for HER2- breast cancer and Docetaxel/Carboplatin/Herceptin for HER2+ breast cancer
Region
| Japan |
Condition
Condition
Primary breast cancer
Classification by specialty
| Hematology and clinical oncology | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate safety, clinicopathological outcome and prognosis after systemic primary chemotherapy for stage 2 and 3 breast cancer with 2cm and more in size.
1)HER2-negative breast cancer patients recieve sequential regimen of 4 cycles of Nanoparticle Albumin-bound paclitaxel followed by 4 cycles of epirubicin and cyclophophamide.
(2)HER2-positive breast cancer patients recieve concurrent regimen of 6cycles of Docetaxel(DOC), Carboplatin(CBDCA) and Trastuzumab.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Rate of pathological complete response
Key secondary outcomes
Postsurgical histological response,
Rate of breast conservative surgery, clinical response, and adverse effect
DFS and overall survival
Exploratory study of imaing and molecular biomarkers
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 chemotherapy using Nab-Paclitaxel followed by Epirubicin and Cyclophosphamide for HER2 negative primary breast cancer and Docetaxel/Carboplatin/Herceptin3 for HER2 positive breast cancer
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
Male and Female
Key inclusion criteria
Stage 2 and 3 primary breast cancer patients who are eligible for chemotherapy
Key exclusion criteria
Patients who are ineligible for chemotherapy
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiaki Saeki |
Organization
International Medical Center, Saitama Medical University
Division name
Dept of breast oncology
Zip code
Address
1397-1 Yamane, Hidaka, Saitama, Japan
TEL
042-984-4111
syueda@saitma-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shigeto UEDA |
Organization
International Medical Center, Saitama Medical University
Division name
Dept of breast oncology
Zip code
Address
1397-1 Yamane, Hidaka, Saitama
TEL
042-984-4111
Homepage URL
syueda@saitma-med.ac.jp
Sponsor or person
Institute
Dept of breast oncology
Institute
Department
Personal name
Funding Source
Organization
Dept of breast oncology
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
| 2014 | Year | 03 | Month | 25 | 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
Enrolling by invitation
Date of protocol fixation
| 2011 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 10 | 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
| 2014 | Year | 03 | Month | 25 | Day |
Last modified on
| 2014 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007653
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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