UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004741 |
|---|---|
| Receipt number | R000005386 |
| Scientific Title | A phase 2 study of weekly Paclitaxel plus Gemcitabine Combination Chemotherapy in Patients with advanced or metastatic Breast Cancer |
| Date of disclosure of the study information | 2010/12/17 |
| Last modified on | 2018/07/13 10:22:59 |
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Basic information
Public title
A phase 2 study of weekly Paclitaxel plus Gemcitabine Combination Chemotherapy in Patients with advanced or metastatic Breast Cancer
Acronym
A Phase 2 study of weekly paclitaxel plus Gemcitabine Combination Chemotherapy in Patients with advanced or metastatic Breast Cancer
Scientific Title
A phase 2 study of weekly Paclitaxel plus Gemcitabine Combination Chemotherapy in Patients with advanced or metastatic Breast Cancer
Scientific Title:Acronym
A Phase 2 study of weekly paclitaxel plus Gemcitabine Combination Chemotherapy in Patients with advanced or metastatic Breast Cancer
Region
| Japan |
Condition
Condition
Breast Cancer
Classification by specialty
| Hematology and clinical oncology | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate effectiveness and safety of weekly Paclitaxel plus Gemcitabine combination therapy in patients with advanced or metastatic Breast Cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Response rate
Key secondary outcomes
Progression free survival,
Overall survival,
Time to treatment failure,
Safety profiles
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
Paclitaxel 80mg/m2,iv, Day1/8/15
Gemcitabine 1200mg/m2,iv,Day1/8
Every28 days
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)Patient who confirmed histologically HER2 negative as Metastatic breast cancer
2)ECOG PS 0-1
3)Mesurable disease as per RECIST criteria
4)Patients who don't have recieved Taxans and Gemcitabine
5)Adequate organ functions confirmed with following major examination conducted within 14 days before each patient's registration
leukocyte>=3000mm3 or neutrophil>=1500mm3
hemoglobin>=9.0g/dL
platelet count>=100,000/mm3
AST,ALT<=100IU/L
total bilirubin=<1.5mg/dL
serum creatinine<=1.5mg/dL
6)Expected survival time: more than 6 months
7)Clinically no problem with an electrocardiogram
8) Given written informed concent
Key exclusion criteria
1) Pulmonary fibrosis or pneumonia
2) body cavity fluid whichi needs to be treated
3)Symptomatic brain metastasis
4) Active double cancer
5) The diabetes that is impossible of control and high blood pressure case
6)HBs antigen positive
7)Heart diseases with the following items
History of myocardial infarction ,unstable angina,post status of PTCA or CABG occurred within past 6 months
Congestive heart failure
Arrhythmia which needed to be treated
8)Apparently/possibly during pregnancy or lactation expectant
9) Serious drug allergy
10) Judged by the investigator to be unfit to be enrolled into the study
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinya Tokunaga |
Organization
Osaka City General Hospital
Division name
Department of Medical Oncology
Zip code
Address
534-0021 2-13-22,miyakojima-hondori,miyakojima-ku,Osaka
TEL
06-6929-1221
s-tokunaga@med.osakacity-hp.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Norikazu Masuda |
Organization
Kinki Multidisciplinary Breast Oncology Group
Division name
Executive office
Zip code
Address
540-0006 2-1-14,hoenzaka,chuo-ku,Osaka
TEL
06-6942-1331
Homepage URL
nmasuda@alpha.ocn.ne.jp
Sponsor or person
Institute
Kinki Multidisciplinary Breast Oncology Group
Institute
Department
Personal name
Funding Source
Organization
Sakai Clinical Research Supporting Center(SCRSC)
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
JAPAN
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
| 2010 | Year | 12 | Month | 17 | 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
Completed
Date of protocol fixation
| 2010 | Year | 09 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2013 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2013 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2013 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 12 | Month | 17 | Day |
Last modified on
| 2018 | Year | 07 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005386
