Unique ID issued by UMIN | UMIN000008848 |
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Receipt number | R000005165 |
Scientific Title | Phase 1/2 study of weekly paclitaxel and gemcitabine in patient with HER2 negative recurrent breast cancer |
Date of disclosure of the study information | 2012/09/04 |
Last modified on | 2019/03/12 01:32:18 |
Phase 1/2 study of weekly paclitaxel and gemcitabine in patient with HER2 negative recurrent breast cancer
Phase 1/2 study of weekly paclitaxel and gemcitabine in patient with HER2 negative recurrent breast cance
Phase 1/2 study of weekly paclitaxel and gemcitabine in patient with HER2 negative recurrent breast cancer
Phase 1/2 study of weekly paclitaxel and gemcitabine in patient with HER2 negative recurrent breast cance
Japan |
Breast Cancer
Hematology and clinical oncology | Breast surgery |
Malignancy
NO
To evaluate maximum tolerated dose to determine recommended dose of gemcitabine and weekly paclitaxel in Her2 negative Recurrent breast cancer patients. In the next phase, we evaluate the safety and efficacy with recommended dose for these patients.
Safety,Efficacy
To determine maximum tolerated dose and recommended dose
adverse events
time to progression
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
The optimal dosage of gemcitabine plus paclitaxel is decided by the dose limiting toxicity
20 | years-old | <= |
75 | years-old | > |
Female
1.histologically or cytologically confirmed locally advanced breast cancer or metastatic breast cancer
2.HER2 negative
3.over 20 years old, under 75 years old
4.ECOG performance status--0 or 1
5.All Pts are
1:after receiving anthracycline containing regimen for neoadjuvant and adjuvant setting, but no prior chemotherapy for metastatic disease including taxanes must have been completed more than 12 months before registering in this study
2:after receiving one regimen for locally advanced breast cancer including taxanes must have been completed more than 12 months before registering in this study
6.Patients who have passed the following periods from previous treatment
1:immunotherapy/endocrinetherapy
14 days from the final administration,
in case of LH-RH analogue, 28 days are
needed
2:chemotherapy 28 days
3:radiation therapy 28 days
4:operation 7 days
*Her2 positive
*Prior administration of gemcitabine
*Pulmonary fibrosis or pneumonitis
*Abnormal cardiac function, myocardial infarction within 6 months
*Body cavity fluid which needs to treatment
*Active infection
*Severe complicated situation
*Severe drug allergic reaction
*Serious psychiatric illness
*After bone marrow transplantation
*After stem cell transplantation
*Symptomatic systemic brain metastasis
*Active double cancer
*Double chemotherapy
*Pregnancy, breast feeding, suspected pregnancy
45
1st name | |
Middle name | |
Last name | Shigeru Murakami |
Hiroshima City Asa Hospital
Breast Surgery
2-1-1 Kabeminami Asakita-ku Hiroshima
0828155211
1st name | |
Middle name | |
Last name | Shigeru Murakami |
Hiroshima Breast Cancer Study Group
Hiroshima Cancer Support
1-20, Honkawa-cho, Naka-ku, Hiroshima
0825443770
http://www.hiroshima-cs.jp/
shigeru126@gmail.com
Hiroshima Breast Cancer Study Group
Hiroshima Breast Cancer Study Group
Self funding
NO
Hiroshima Breast Cancer Study Group(広島県)
2012 | Year | 09 | Month | 04 | Day |
Unpublished
Terminated
2010 | Year | 07 | Month | 15 | Day |
2010 | Year | 09 | Month | 30 | Day |
2010 | Year | 12 | Month | 01 | Day |
2012 | Year | 12 | Month | 31 | Day |
2012 | Year | 09 | Month | 04 | Day |
2019 | Year | 03 | Month | 12 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005165
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