UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009973 |
|---|---|
| Receipt number | R000011679 |
| Scientific Title | Phase I Study of Nanoparticle albumin-bound paclitaxel and Cyclophosphamide combination chemotherapy for Patients with Metastatic Breast Cancer(GBCCSG-02) |
| Date of disclosure of the study information | 2013/02/06 |
| Last modified on | 2013/02/06 10:34:33 |
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Basic information
Public title
Phase I Study of Nanoparticle albumin-bound paclitaxel and Cyclophosphamide combination chemotherapy for Patients with Metastatic Breast Cancer(GBCCSG-02)
Acronym
Phase I Study of AbraC for MBC (GBCCSG-02)
Scientific Title
Phase I Study of Nanoparticle albumin-bound paclitaxel and Cyclophosphamide combination chemotherapy for Patients with Metastatic Breast Cancer(GBCCSG-02)
Scientific Title:Acronym
Phase I Study of AbraC for MBC (GBCCSG-02)
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
To evaluate maximum tolerated dose to determine recommended dose of tri-weekly Nab-paclitaxel and Cyclophosphamide combination chemotherapy for patients with metastatic breast cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
To evaluate maximum tolerated dose to determine recommended dose
Key secondary outcomes
Response rate
Safety
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:180-260mg/m2
Cyclophosphamide:600mg/m2
If Her2 is overexpression
Trastuzumab:1st time 8 mg/kg,2nd and subsequent 6 mg/kg
Cycles are repeated 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
| 75 | years-old | > |
Gender
Female
Key inclusion criteria
1)Histologically or cytologically confirmed inoperable breast cancer with recurrence or metastasis.
2)Adjuvant or neo adjuvant chemotherapy for breast cancer must have been completed more than 12 months before registering in this study. Or prior chemotherapy for metastatic disease have been included Nab-paclitaxel.
3)Operation and radiation therapy and chemotherapy >= 2 weeks and Hormonal therapy and administrated Trastuzumab >= 4 weeks.
4)Age more than 20 years and less than 75 years At registration.
5)ECOG performance status of 0 to 2.
6)Required baseline laboratory parameters (within 14 days before registration):
Hb more than 9.0g/dl
WBC more than 4,000 /mm3
Neu more than 2,000 / 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
7)Patients have enough organ function for study treatment.
8)No severe infectious disease
9)Life expectancy of more than 3 months
10)If Patients who have HER2-positive cancer confirmed with IHC and/or FISH (IHC 3+ or IHC 2+ and FISH positive) use Trastuzumab together, they have over 50% of LVEF.
11)Signed informed consent of the patient for the registration.
Key exclusion criteria
1)History of serious allergy for nab-paclitaxe, cyclophosphamide, paclitaxel or albumin
2)Patients who applied radiation therapy, adjuvant or neo adjuvant chemotherapy within 3 weeks before registraion
3)Serious complication.
4)Active other malignancies
5)Symptomatic brain metastasis
6)peripheral nerve disorder =>Grade2
7)Patients in pregnancy, at risk of pregnancy,
8)Patients judged inappropriate by physicians
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Jun Horiguchi |
Organization
Gunma University Hospital
Division name
Thoracic and visceral organ surgery
Zip code
Address
3-39-15 Showa-machi, Maebashi-city, Gunma, 371-8511, Japan
TEL
027-220-8245
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Jun Horiguchi |
Organization
Gunma Breast Clinical Conference Study Group(GBCCSG)
Division name
Secretariat Division (Thoracic Visceral Organ Surgery , Gunma University)
Zip code
Address
3-39-15 Showa-machi, Maebashi-city, Gunma, 371-8511, Japan
TEL
027-220-8245
Homepage URL
Sponsor or person
Institute
Gunma Breast Clinical Conference Study Group(GBCCSG)
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
| 2013 | Year | 02 | Month | 06 | 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 | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 04 | Month | 30 | 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 | 02 | Month | 06 | Day |
Last modified on
| 2013 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011679
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