UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009153 |
|---|---|
| Receipt number | R000010732 |
| Scientific Title | Phese 2 trial of weekly nab-paclitaxel in combination with gemcitabine in patients with metastatic breast cancer who have failed prior chemotherapy |
| Date of disclosure of the study information | 2012/10/19 |
| Last modified on | 2013/10/21 19:50:42 |
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Basic information
Public title
Phese 2 trial of weekly nab-paclitaxel in combination with gemcitabine in patients with metastatic breast cancer who have failed prior chemotherapy
Acronym
Phese 2 trial of weekly nab-paclitaxel in combination with gemcitabine in patients with metastatic breast cancer who have failed prior chemotherapy
Scientific Title
Phese 2 trial of weekly nab-paclitaxel in combination with gemcitabine in patients with metastatic breast cancer who have failed prior chemotherapy
Scientific Title:Acronym
Phese 2 trial of weekly nab-paclitaxel in combination with gemcitabine in patients with metastatic breast cancer who have failed prior chemotherapy
Region
| Japan |
Condition
Condition
Metastatic and Recurrenced Breast Cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to assess the efficary and safty of weekly nab-paclitaxel in combination with gemcitabine in Japanese partients with metastatic breast cancer who have failed prior chemotherapies
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
PFS,OS,Safty
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
Nab-paclitaxel:125mg/m2 intravenously administred on day 1,8 every 3 weeks
Gemcitabine:1000mg/m2 intravenously administred on day 1,8 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
| Not applicable |
Gender
Female
Key inclusion criteria
1.Histologically confirmed Breast cancer
2.Inoperative metastatic or recurrent breast cancer
3.Patients with evaluable lesion
4. Age >=20
5.Patients with at least one or more prior chemotherapy
6.Sufficient organ functions
Hemoglobin >=9.0g/dl
WBC >=4000/mm3
Neurtophils >=2000/mm3
Platelets >=100,000/mm3
Total bilirubin <=1.5mg/dl
GOT and GPT < ULNx2.5
Creatinine <1.5mg/dl
7.Performance status 0-1
8.Patients who have passed the following periods from previous treatment
Endocrinetherapy:7 days from the final administration
Adjuvant:6 months from the final administration
9.Written IC
Key exclusion criteria
1.Inflammatory and bilateral breast cancer
2.Active another cancer
3.History of hypersensitivity reaction
4. Other severe complications, such as pulmonary emphysema or pulmonary fibrosis, uncontrollable diabetes, heart failure, renal insufficiency, liver failure
5.Neuropathy <= grade1
6. Radiation therapy for chest
7.Serious myeloablation
8.Infection
9.Pregnant or possibility pregnancy or nursing woman
10.Physician judged improper to entry this trial
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinsaku Kanazawa |
Organization
Toho University Omori Medical Center
Division name
Breast and Endocrine Surgery
Zip code
Address
6-1-11,Omori-Nishi,Ota-ku,Tokyo 143-8541,Japan
TEL
03-3762-4151
sg0713sk@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinsaku Kanazawa |
Organization
Toho University Omori Medical Center
Division name
Breast and Endocrine Surgery
Zip code
Address
6-1-11,Omori-Nishi,Ota-ku,Tokyo 143-8541,Japan
TEL
03-3762-4151
Homepage URL
sg0713sk@med.toho-u.ac.jp
Sponsor or person
Institute
Toho University Omori Medical Center
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
| 2012 | Year | 10 | Month | 19 | 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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 10 | Month | 19 | Day |
Last modified on
| 2013 | Year | 10 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010732
