UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004084 |
|---|---|
| Receipt number | R000004920 |
| Scientific Title | Phase1 trial of weekly paclitaxel and gemcitabine in previously anthracycline-treated patients with locally advanced or metastatic breast cancer (SBCCSG-17) |
| Date of disclosure of the study information | 2010/08/22 |
| Last modified on | 2017/11/30 18:05:40 |
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Basic information
Public title
Phase1 trial of weekly paclitaxel and gemcitabine in previously anthracycline-treated patients with locally advanced or metastatic breast cancer (SBCCSG-17)
Acronym
Phase1 trial of weekly paclitaxel and gemcitabine
Scientific Title
Phase1 trial of weekly paclitaxel and gemcitabine in previously anthracycline-treated patients with locally advanced or metastatic breast cancer (SBCCSG-17)
Scientific Title:Acronym
Phase1 trial of weekly paclitaxel and gemcitabine
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
The dosing history of anti-cancer drug decides dosage of weekly gemcitabine and paclitaxel using together intended for patients with locally advanced and metastatic breast cancer and safety is verified.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The optimal dosage is eventually decided by the frequency of dose limiting toxicities at the first course in each dose level.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 is histologically or cytologically confirmed as locally advanced or metastatic breast cancer.
2)Patient who had relapsed after receiving anthracycline-based chemotherapy regimen. Taxanes must have been completed more than 6 months.
3)Patient who have passed the following periods from previous treatment completion date:
A.Immunotherapy/endocrinotherapy; at least 14 days from the final administration date (Slow-release formulations of LH-RH agonist needs at least 28 days).
B.Chemotherapy; at least 28 days from the final administration date.
C.Radiotherapy; at least 28 days from the final treatment date.
D.Treatment with antibodies; at least 28 days from the final administration date.
4)Patient has received radiation to not more than 20% of the bone marrow area.
5)There is no regulation concerning the hormonal therapy.
6)Performance status (PS) 0-1.
7)Patient has adequate organ functions confirmed with following major examinations conducted within 14 days before each patient's registration.
8)Patient has given written informed consent.
Key exclusion criteria
1)Patient had received gemcitabine treatment in the past.
2)Patient with inflammatory carcinoma.
3)Patient apparently or possibly has pulmonary fibrosis or pneumonia.
4)Patient is class III or IV of NYHA functional classification or patient has cardiac infarction occurred within past six months.
5)Patient has body cavity fluid which needs to be treated.
6)Patient has active infection.
7)Patient has serious coexisting illness (including diabetes which is difficult to control).
8)Patient has serious drug allergy.
9)Patient has serious psychiatric illness that can make his/her decisions unstable or uncertain.
10)Patient had had bone marrow transplantation or stem cell transplantation.
11)Patient has symptomatic brain metastasis.
12)Patient receives continuous whole-body administration of steroid drugs (orally or intravenously.)
13)Patient has active double cancer.
14)Patient is apparently/possibly during pregnancy, lactation expectant, or desiring future fertility in the period from informed consent day to 3 months after final test drug administration.
15)Patient has received unapproved drugs or other investigational drugs within 30 days before the registration date.
16)Patient is judged unsuitable as object of this clinical trial by the principal investigator or the physician in charge.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shigenori Nagai |
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
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' MammoClinic)
Zip code
Address
3F Captal 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
| 2010 | Year | 08 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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 | 08 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 08 | 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
The optimal dosage is eventually decided by the frequency of dose limiting toxicities at the first course in each dose level.
Management information
Registered date
| 2010 | Year | 08 | Month | 22 | Day |
Last modified on
| 2017 | Year | 11 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004920
