UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019787 |
|---|---|
| Receipt number | R000022855 |
| Scientific Title | Phase 2 clinical study of neoadjuvant chemotherapy for HER2-negative primary breast cancer patients using dose dense nab-paclitaxel followed by dose dense Epirubicin and cyclophosphamide |
| Date of disclosure of the study information | 2016/01/01 |
| Last modified on | 2015/11/14 13:38:37 |
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Basic information
Public title
Phase 2 clinical study of neoadjuvant chemotherapy for HER2-negative primary breast cancer patients using dose dense nab-paclitaxel followed by dose dense Epirubicin and cyclophosphamide
Acronym
Neoadjuvant dose-dense chemotherapy for HER2 negative breast cancer
Scientific Title
Phase 2 clinical study of neoadjuvant chemotherapy for HER2-negative primary breast cancer patients using dose dense nab-paclitaxel followed by dose dense Epirubicin and cyclophosphamide
Scientific Title:Acronym
Neoadjuvant dose-dense chemotherapy for HER2 negative breast cancer
Region
| Japan |
Condition
Condition
HER2 negative primary breast cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and safety of dose dense neoadjuvant chemotherapy for HER2-negative primary breast cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
pCR rate
Key secondary outcomes
Histological response rate, breast consercing surgery rate, adverse event, DFS, OS
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
Nab Paclitaxel 4 cycleq2w (260 mg/m2)
followed by EC 4 cycle q2w
(Epirubicin 90mg/m2)
(Cyclophosphamide 600mg/m2)
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
| 76 | years-old | > |
Gender
Female
Key inclusion criteria
1) Conferm histology of invasive ductal carcinoma, HER2 negative status
2) Age 20>= 75<=
3) Performance status ECOG scale 0-1
4) No pvevious treatment of present breast cancer
Key exclusion criteria
1) HER2 positivity
2) Previous incident of severe complication
3) Previous incident of institutional pneumonia
4) Previous incident of drug allergy
5) Active status of other cancers
6) Inflammatory breast cancer
7) Possible pregnancy
Target sample size
50
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@saitama-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, Japan
TEL
042-984-4111
Homepage URL
syueda@saitama-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
| 2016 | Year | 01 | 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
Preinitiation
Date of protocol fixation
| 2015 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | 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
| 2015 | Year | 11 | Month | 14 | Day |
Last modified on
| 2015 | Year | 11 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022855
