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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000006085
Receipt No. 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

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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
Email 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/
Email toshikai@sbccsg.org

Sponsor
Institute Saitama Breast Cancer Clinical Study Group(SBCCSG)
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007204

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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