UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009853 |
|---|---|
| Receipt number | R000011543 |
| Scientific Title | Phase II trial of Epirubicin / Cyclophosphamide (EC) followed by Nab-paclitaxel as neoadjuvant chemotherapy for node positive breast cancer |
| Date of disclosure of the study information | 2013/02/01 |
| Last modified on | 2016/08/09 21:44:43 |
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Basic information
Public title
Phase II trial of Epirubicin / Cyclophosphamide (EC) followed by Nab-paclitaxel as neoadjuvant chemotherapy for node positive breast cancer
Acronym
EC followed by ABI neoadjuvant chemotherapy for node positive breast cancer (Phase II Trial)
Scientific Title
Phase II trial of Epirubicin / Cyclophosphamide (EC) followed by Nab-paclitaxel as neoadjuvant chemotherapy for node positive breast cancer
Scientific Title:Acronym
EC followed by ABI neoadjuvant chemotherapy for node positive breast cancer (Phase II Trial)
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 Nab-paclitaxel as neoadjuvant chemotherapy for node positive breast cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Primary endpoint is to evaluate the pathological CR rate.
Key secondary outcomes
Secondary endpoint is to evaluate the Clinical response rate, pathological response rate,
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
EC(Epi-ADM 90mg/m2 and Cyclophosphamide 600mg/m2) is administered. One course is consisted by 3 weeks and repeated to 4 courses.
After administrated 4 courses of EC, ABI 260mg/m2 is administered. One course is consisted by 3 weeks and repeated to 4 courses.
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
| 70 | years-old | >= |
Gender
Female
Key inclusion criteria
1) Histologically breast cancer confirmed by needle biopsy.
2) Clinical stage T1-3, >=N1, M0
3) expected to radical cure by operation and neoadjuvant chemotherapy
4) has measurable region
5) Age 20 to 70
6) No prior surgery, radiation, chemotherapy and endcrinethrapy
7) Required baseline laboratory parameters (within 2 weeks before registration):
Hb more than 9.0g/dl
WBC more than 4000 /mm3
Neu more than 2000 / mm3
Plt more than 100,000/mm3
T-Bil less than 1.5 mg/dL
AST(GOT) less than 2.5-times the upper limit of normal
ALT(GPT) less than 2.5-times the upper limit of normal
Cre less than 1.5 mg/dL
cardiac electrogram : No clinically important abnormal finding
8)ECOG performance status is 0 to 1
9)Signed informed consent of the patient for the registration by their own volition.
Key exclusion criteria
1) History of sever hypersensitivity
2) Active other malignancies
3) Severe complications (infection, uncontrolled diabetes mellitus, uncontrolled angina, heart infarction within 6 months, heart failure etc.)
4) has psychological illness which became a problem in practice
5) sever bone suppression, renal dysfunction, and liver dysfunction
6) sever pleural effusion or ascites fluid
7) has infection or fever which suspected of infection
8) pregnant or possibility of pregnant
9) Patients judged inappropriate by physicians
Target sample size
23
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Kato |
Organization
Dokkyo Medical University
Division name
Surgery 1
Zip code
Address
880 Kitakobayashi, Mibu, Tochigi, Japan
TEL
0282-87-2157
hkato@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Jun Ito |
Organization
Dokkyo Medical University
Division name
Surgery 1
Zip code
Address
880 Kitakobayashi, Mibu, Tochigi, Japan
TEL
0282-87-2157
Homepage URL
j-ito@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University
Institute
Department
Personal name
Funding Source
Organization
Dokkyo Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
| 2013 | Year | 02 | 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
Completed
Date of protocol fixation
| 2011 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 01 | Month | 23 | Day |
Last modified on
| 2016 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011543
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