UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000504 |
|---|---|
| Receipt number | R000000609 |
| Scientific Title | The safety and efficacy trial of sequential administration with AP (Doxorubicin/Paclitaxel) followed by weekly Paclitaxel as preoperative chemotherapy for breast cancer: SBCCSG-07 |
| Date of disclosure of the study information | 2006/10/30 |
| Last modified on | 2018/12/18 19:50:29 |
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Basic information
Public title
The safety and efficacy trial of sequential administration with AP (Doxorubicin/Paclitaxel) followed by weekly Paclitaxel as preoperative chemotherapy for breast cancer: SBCCSG-07
Acronym
The safety and efficacy trial of sequential administration with AP (Doxorubicin/Paclitaxel) followed by weekly Paclitaxel as preoperative chemotherapy for breast cancer: SBCCSG-07
Scientific Title
The safety and efficacy trial of sequential administration with AP (Doxorubicin/Paclitaxel) followed by weekly Paclitaxel as preoperative chemotherapy for breast cancer: SBCCSG-07
Scientific Title:Acronym
The safety and efficacy trial of sequential administration with AP (Doxorubicin/Paclitaxel) followed by weekly Paclitaxel as preoperative chemotherapy for breast cancer: SBCCSG-07
Region
| Japan |
Condition
Condition
Primary breast cancer
Classification by specialty
| Hematology and clinical oncology | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to evaluate the efficacy and safety of sequential chemotherapy with AP (Doxorubicin/Paclitaxel) followed by weekly Paclitaxel as preoperative chemotherapy for breast cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Pathological complete response rate
Clinical complete response rate
Key secondary outcomes
Disease-free survival
Overall survival
Toxicity
Breast conserving rate
The rate of completion
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
Doxorubicin 50mg/m2, Paclitaxel 150mg/m2, q3Wx4cycles followed by paclitaxel 80mg/m2, q1Wx12cycles
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
| 70 | years-old | >= |
Gender
Female
Key inclusion criteria
1. Histologically-proven breast cancer except for inflammatory breast cancer
2. tumor diameter confirmed >=2cm and incidence of axillary metastasis
3. previously untreated with chemotherapy
4. Age >=20, <=70
5. PS(ECOG) 0-1
6. Written informed consent
7. No operation
8. Adequate organ function
Key exclusion criteria
1. severe complication
2. suspicious of infection
3. past history of allergic reaction to cremophor EL (polyoxyethylated caster oil) or polysorbate
4. Pregnant or lactating women
5. Doctor's decision for exclusion
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshio Tabei |
Organization
Saitama Cancer Center
Division name
Endocrinology
Zip code
Address
818 Komuro Ina-machi Kitaadachi-gun, Saitama 362-0806
TEL
048-722-1111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshihiro Kai |
Organization
Saitama Breast Cancer Clinical Study Group (SBCCSG)
Division name
Executive office
Zip code
Address
4-261-1 Kishiki-cho, Omiya-ku, Saitama City, Saitama 330-0843
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
| 2006 | Year | 10 | Month | 30 | 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
No longer recruiting
Date of protocol fixation
| 2005 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 11 | Month | 28 | Day |
Last follow-up date
| 2019 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2019 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2019 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2019 | Year | 10 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2006 | Year | 10 | Month | 27 | Day |
Last modified on
| 2018 | Year | 12 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000609
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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