UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005414 |
|---|---|
| Receipt number | 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 19:58:37 |
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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
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/
toshikai@sbccsg.org
Sponsor or person
Institute
Saitama Breast Cancer Clinical Study Group(SBCCSG)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006423
