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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000005414
Receipt No. R000006423
Scientific Title A Multicenter Phase II Study of Tri-weekly Nab-Paclitaxel for Patients with Metastatic Breast Cancer Pretreated with Taxanes (SBCCSG-20)
Date of disclosure of the study information 2011/04/09
Last modified on 2018/12/18

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Basic information
Public title A Multicenter Phase II Study of Tri-weekly Nab-Paclitaxel for Patients with Metastatic Breast Cancer Pretreated with Taxanes (SBCCSG-20)
Acronym Phase II Study of Tri-weekly Nab-Paclitaxel for MBC Pretreated with Taxanes (SBCCSG-20)
Scientific Title A Multicenter Phase II Study of Tri-weekly Nab-Paclitaxel for Patients with Metastatic Breast Cancer Pretreated with Taxanes (SBCCSG-20)
Scientific Title:Acronym 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
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

Other administrative information
Date of disclosure of the study information
2011 Year 04 Month 09 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 04 Month 01 Day
Date of IRB
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

Other
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

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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