UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012428 |
|---|---|
| Receipt number | R000014545 |
| Scientific Title | A feasibility study of Anthracycline-based regimen followed by Nab-Paclitaxel as adjuvant chemotherapy for breast cancer.(SBCCSG-32) |
| Date of disclosure of the study information | 2013/12/02 |
| Last modified on | 2018/12/18 20:09:29 |
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Basic information
Public title
A feasibility study of Anthracycline-based regimen followed by Nab-Paclitaxel as adjuvant chemotherapy for breast cancer.(SBCCSG-32)
Acronym
A feasibility study of Anthracycline-based regimen followed by Nab-Paclitaxel as adjuvant chemotherapy for breast cancer.(SBCCSG-32)
Scientific Title
A feasibility study of Anthracycline-based regimen followed by Nab-Paclitaxel as adjuvant chemotherapy for breast cancer.(SBCCSG-32)
Scientific Title:Acronym
A feasibility study of Anthracycline-based regimen followed by Nab-Paclitaxel as adjuvant chemotherapy for breast cancer.(SBCCSG-32)
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
Evaluate the feasibility and safety of four cycles Anthracycline base regimen and four cycles Nab-paclitaxel for patients as adjuvant 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
Feasibility
Key secondary outcomes
Safety
Overall survival
Disease free survival
Relation between Relative Dose Intensity (RDI) of Nab-Paclitaxel and Disease Free Survival ratio
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
4 cycles of Anthracycline base adjuvant chemotherapy followed by 4 cycles of Nab-paclitaxel. The regimen for Nab-paclitaxel is 260 mg/m2 administered intravenously over 30 minutes 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
| 18 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Female
Key inclusion criteria
1) Histologically confirmed breast cancer.
2) Stage I, IIA, IIB, IIIA
3) The adjuvant chemotherapy is necessary
4) Age more than 20 years and less than 70 years.
5) ECOG performance status of 0 to 1
6) Within 6 weeks after surgery
7) Adequate major organ function.
8) Required baseline laboratory parameters (within 14 days before registration):
Hb more than 9.0g/dl
WBC more than 3000 /mm3
Neu more than 1500 / mm3
Plt more than 100,000/mm3
AST less than 2.5 times ULN
ALT less than 2.5 times ULN
T-Bil less than 1.5mg/dl
Cre less than 1.5mg/dl
Cardiac function normal ECG
9) Signed informed consent of the patient for the registration.
Key exclusion criteria
1) HER2 is positive by surgical specimen.
2) Pregnant or lactation women.
3) History of other malignancies within the last 5 years.
4) History of bilateral breast cancer
5) History of serious allergy
6) Patients judged by the investigator to be unfit to be enrolled into the study.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tsuyoshi Saito |
Organization
Saitama Red Cross Hospital
Division name
Breast Surgery
Zip code
Address
8-3-33 Kamiochiai Chuo-ku Saitama-shi, 338-8553, Japan
TEL
048-852-1111
tsaito@jcom.home.ne.jp
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' Mammo Clinic)
Zip code
Address
3F Capital 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
さいたま赤十字病院（埼玉県），埼玉県立がんセンター（埼玉県），埼玉社会保険病院（埼玉県），自治医大さいたま医療センター（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 12 | Month | 02 | 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
No longer recruiting
Date of protocol fixation
| 2013 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | Month | 02 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 11 | Month | 28 | 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=R000014545
