UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006085 |
|---|---|
| Receipt number | R000007204 |
| Scientific Title | A feasibility study of sequential Anthracycline-based regimen and Nab-Paclitaxel / Trastuzumab followed by Trastuzumab as postoperative adjuvant chemotherapy for Her2 positive breast cancer.(SBCCSG-22) |
| Date of disclosure of the study information | 2011/08/01 |
| Last modified on | 2018/12/18 20:10:30 |
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Basic information
Public title
A feasibility study of sequential Anthracycline-based regimen and Nab-Paclitaxel / Trastuzumab followed by Trastuzumab as postoperative adjuvant chemotherapy for Her2 positive breast cancer.(SBCCSG-22)
Acronym
Anthracycline, Nab-Paclitaxel and Trastuzumab in the adjuvant therapy of HER-2 positive breast cancer.(SBCCSG-22)
Scientific Title
A feasibility study of sequential Anthracycline-based regimen and Nab-Paclitaxel / Trastuzumab followed by Trastuzumab as postoperative adjuvant chemotherapy for Her2 positive breast cancer.(SBCCSG-22)
Scientific Title:Acronym
Anthracycline, Nab-Paclitaxel and Trastuzumab in the adjuvant therapy of HER-2 positive breast cancer.(SBCCSG-22)
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
Evaluate the feasibility and safety of adjuvant chemotherapy that are Anthracycline-based regimen followed by Nab-paclitaxel and Trastuzumab.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Feasibility
Key secondary outcomes
Safety
Overall survival
Disease free survival
Relation between Relative Dose Intensity (RDI) of Nab-Paclitaxel and Disease Free Survival ratio
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
For the postoperative adjuvant chemotherapy, Anthracycline Base is done four times, and administering Nab-Paclitaxel and Trastuzumab begins. Nab-Paclitaxel is administered in a dose of 260mg/m2 by once every three weeks for four cycles. Trastuzumab is administered in a loading dose of 8 mg / kg of body weight, followed by a dose of 6 mg / kg once three weeks, for one year.
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
| 18 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Female
Key inclusion criteria
1) Histologically confirmed breast cancer.
2) HER2 Overexpression (IHC 3+ or FISH +)
3) Stage I, IIA, IIB, IIIA
4) Age m than 20 years and less than 70 years.
5) ECOG performance status of 0 to 1
6) LVEF more than 55%
7) Within 6 weeks after surgery
8) Sufficient organ function
9) Required baseline laboratory parameters (within 14 days before registration):
Hb more than 9.0g/dl
WBC more than 3000 /mm3
Neu more than 1500 / mm3
Plt more than 100,000/mm3
AST less than 2.5 times ULN
ALT less than 2.5 times ULN
T-Bil less than 1.5mg/dl
Cre less than 1.5mg/dl
10) Signed informed consent of the patient for the registration.ore
Key exclusion criteria
1) Pregnant or lactation women.
2) History of other malignancies within the last 5 years.
3) History of bilateral breast cancer
4) History of serious allergy
5) Serious cardiac disfunction
6) Patients judged by the investigator to be unfit to be enrolled into the study.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenichi Inoue |
Organization
Saitama Cancer Center
Division name
Breast Medical Oncology
Zip code
Address
818 Ina-machi oaza komuro, Kita-adachi-gun, Saitama, 362-0806, Japan
TEL
048-722-1111
ino@cancer-c.pref.saitama.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshihiro Kai |
Organization
Saitama Breast Cancer Clinical Study Group(SBCCSG)
Division name
Secretariat Division (Shintoshin Ladies' Mammo Clinic)
Zip code
Address
3F Capital building, 4-261-1 Kishiki-cho, Omiya-ku, Saitama-shi, 330-0843, Japan
TEL
048-600-1722
Homepage URL
http://www.sbccsg.org/
toshikai@sbccsg.org
Sponsor or person
Institute
Saitama Breast Cancer Clinical Study Group(SBCCSG)
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
埼玉県立がんセンター、さいたま赤十字病院、自治医大さいたま医療センター、
埼玉社会保険病院、春日部市立病院
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 08 | 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
No longer recruiting
Date of protocol fixation
| 2011 | Year | 05 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
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 | 31 | Day |
Last modified on
| 2018 | Year | 12 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007204
