UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005145 |
|---|---|
| Receipt number | R000006048 |
| Scientific Title | Phase II trial evaluating gemcitabine + nanoparticle albumin-bound paclitaxel in patients with HER2-negative metastatic breast cancer: GAMBA trial |
| Date of disclosure of the study information | 2011/03/01 |
| Last modified on | 2012/02/27 14:04:14 |
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Basic information
Public title
Phase II trial evaluating gemcitabine + nanoparticle albumin-bound paclitaxel in patients with HER2-negative metastatic breast cancer: GAMBA trial
Acronym
GAMBA (Gemzar + Abraxane for Metastatic Breast cAncer) trial
Scientific Title
Phase II trial evaluating gemcitabine + nanoparticle albumin-bound paclitaxel in patients with HER2-negative metastatic breast cancer: GAMBA trial
Scientific Title:Acronym
GAMBA (Gemzar + Abraxane for Metastatic Breast cAncer) trial
Region
| Japan |
Condition
Condition
HER2-negative metastatic breast cancer
Classification by specialty
| Hematology and clinical oncology | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluating efficacy and safety of gemcitabine + nanoparticle albumin-bound paclitaxel in patients with HER2-negative metastatic breast cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Response rate
Key secondary outcomes
Progression-free survival
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
gemcitabine + nanoparticle albumin-bound paclitaxel
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
| 80 | years-old | > |
Gender
Female
Key inclusion criteria
1) Pathologically confirmed invasive breast cancer
2) ECOG performance status 0 or 1
3) HER2-negative metastatic breast cancer
4) At least one measurable lesion
5) Previously untreated with taxanes (Eligible if taxanes are used in neo-adjuvant or adjuvant setting and completed more than 24 weeks before registration.)
6) Previously untreated with gemcitabine
7) Previously treated with no more than one chemotherapy regimen for metastatic disease
Key exclusion criteria
1) Double cancer
2) Pulmonary fibrosis
3) Symptomatic brain metastasis
4) Uncontrolled pleural effusion, pericardial effusion, and ascites
5) HBsAg-positive
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshimi Takano |
Organization
Toranomon Hospital
Division name
Department of Medical Oncology
Zip code
Address
2-2-2 Toranomon, Minato-ku, Tokyo 105-8470, Japan
TEL
03-3588-1111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshimi Takano |
Organization
Toranomon Hospital
Division name
Department of Medical Oncology
Zip code
Address
2-2-2 Toranomon, Minato-ku, Tokyo 105-8470, Japan
TEL
03-3588-1111
Homepage URL
takano@toranomon.gr.jp
Sponsor or person
Institute
Tokyo Breast Cancer Group (TBCG)
Institute
Department
Personal name
Funding Source
Organization
Tokyo Breast Cancer Group (TBCG)
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
虎の門病院（東京都）、聖路加国際病院（東京都）、三井記念病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 03 | Month | 01 | 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
Terminated
Date of protocol fixation
| 2011 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 02 | Month | 25 | Day |
Last modified on
| 2012 | Year | 02 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006048
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
