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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000009973
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Gunma Breast Clinical Conference Study Group(GBCCSG)
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011679

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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