UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Multicenter Phase II Study of Tri-weekly Nab-Paclitaxel for Patients with Metastatic Breast Cancer Pretreated with Taxanes (SBCCSG-20)
Title of the study (Brief title)	Phase II Study of Tri-weekly Nab-Paclitaxel for MBC Pretreated with Taxanes (SBCCSG-20)
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 safety and efficacy of tri-weekly Nab-paclitaxel 260mg/m2 for patients with metastatic breast cancer pretreated with taxanes
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Disease control rate (DCR)
Key secondary outcomes	Response rate Clinical benefit rate Progression free survival Time to treatment failure overall survival Safety

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	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	20 years-old <=
Age-upper limit	75 years-old >
Gender	Female
Key inclusion criteria	1) Histologically or cytologically confirmed inoperable breast cancer with recurrence or metastasis. 2) At least one measurable lesion 3) Previously treated with taxanes (Eligible if taxanes are used in neo-adjuvant or adjuvant setting and completed less than one year before registration.) 4) Any treatment including chemotherapy >=4 weeks. Hormonal therapy and radiation therapy >= 2 weeks 5) Age more than 20years and less than 75 years. 6) ECOG performance status of 0 to 2. 7) 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 8) Patients have enough organ function for study treatment. 9) No severe infectious disease 10) Life expectancy of more than 3 months 11) Signed informed consent of the patient for the registration.
Key exclusion criteria	1) Either of ER, PgR, HER2 is positive by surgical specimen. 2) Previously treated with Nab-paclitaxel. 3) Confirmed histologically HER2 positive. 4) History of serious allergy for paclitaxel or albumin 5) Serious complication. (intestinal paralysis, intestinal obstruction, interstitial pneumonia, lung fibrosis, uncontrolled diabetes mellitus) 6) Symptomatic brain metastasis 7) Active other malignancies 8) Severe psychiatric disorders 9) During pregnancy 10) Patients judged inappropriate by physicians
Target sample size	35

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

Other administrative information
Date of disclosure of the study information	2011 Year 04 Month 09 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2011 Year 04 Month 01 Day
Anticipated trial start date	2011 Year 04 Month 01 Day
Last follow-up date	2021 Year 04 Month 01 Day
Date of closure to data entry	2021 Year 06 Month 01 Day
Date trial data considered complete	2021 Year 08 Month 01 Day
Date analysis concluded	2021 Year 12 Month 31 Day

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

Management information
Registered date	2011 Year 04 Month 08 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=R000006423