UMIN-CTR Clinical Trial

Basic information
Public title	A feasibility study of Anthracycline-based regimen followed by Nab-Paclitaxel as adjuvant chemotherapy for breast cancer.(SBCCSG-32)
Acronym	A feasibility study of Anthracycline-based regimen followed by Nab-Paclitaxel as adjuvant chemotherapy for breast cancer.(SBCCSG-32)
Scientific Title	A feasibility study of Anthracycline-based regimen followed by Nab-Paclitaxel as adjuvant chemotherapy for breast cancer.(SBCCSG-32)
Scientific Title:Acronym	A feasibility study of Anthracycline-based regimen followed by Nab-Paclitaxel as adjuvant chemotherapy for breast cancer.(SBCCSG-32)
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 four cycles Anthracycline base regimen and four cycles Nab-paclitaxel for patients as adjuvant chemotherapy for breast cancer.
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	4 cycles of Anthracycline base adjuvant chemotherapy followed by 4 cycles of Nab-paclitaxel. The regimen for Nab-paclitaxel is 260 mg/m2 administered intravenously over 30 minutes every 3 weeks.
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) Stage I, IIA, IIB, IIIA 3) The adjuvant chemotherapy is necessary 4) Age more than 20 years and less than 70 years. 5) ECOG performance status of 0 to 1 6) Within 6 weeks after surgery 7) Adequate major organ function. 8) 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 Cardiac function normal ECG 9) Signed informed consent of the patient for the registration.
Key exclusion criteria	1) HER2 is positive by surgical specimen. 2) Pregnant or lactation women. 3) History of other malignancies within the last 5 years. 4) History of bilateral breast cancer 5) History of serious allergy 6) Patients judged by the investigator to be unfit to be enrolled into the study.
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Middle name Last name Tsuyoshi Saito
Organization	Saitama Red Cross Hospital
Division name	Breast Surgery
Zip code
Address	8-3-33 Kamiochiai Chuo-ku Saitama-shi, 338-8553, Japan
TEL	048-852-1111
Email	tsaito@jcom.home.ne.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
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IRB Contact (For public release)
Organization
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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	さいたま赤十字病院（埼玉県），埼玉県立がんセンター（埼玉県），埼玉社会保険病院（埼玉県），自治医大さいたま医療センター（埼玉県）

Other administrative information
Date of disclosure of the study information	2013 Year 12 Month 02 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	2013 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date	2013 Year 12 Month 02 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	2013 Year 11 Month 28 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=R000014545

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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