UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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)
Title of the study (Brief title)	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	Kenichi Inoue
Organization	Saitama Cancer Center
Division name	Breast Medical Oncology
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	Toshihiro Kai
Organization	Saitama Breast Cancer Clinical Study Group(SBCCSG)
Division name	Secretariat Division (Shintoshin Ladies' Mammo Clinic)
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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2011 Year 05 Month 09 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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