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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008465
Receipt No. R000009814
Scientific Title PhaseII study of neoadjuvant chemotherapy with the nab Paclitaxel And Trastuzumab followed by FEC for the HER2-positive resectable primary breast cancer
Date of disclosure of the study information 2012/07/18
Last modified on 2018/07/13

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Basic information
Public title PhaseII study of neoadjuvant chemotherapy with the nab Paclitaxel And Trastuzumab followed by FEC for the HER2-positive resectable primary breast cancer
Acronym PhaseII study of neoadjuvant chemotherapy with the nab Paclitaxel And Trastuzumab followed by FEC for the HER2-positive resectable primary breast cancer

Scientific Title PhaseII study of neoadjuvant chemotherapy with the nab Paclitaxel And Trastuzumab followed by FEC for the HER2-positive resectable primary breast cancer
Scientific Title:Acronym PhaseII study of neoadjuvant chemotherapy with the nab Paclitaxel And Trastuzumab followed by FEC for the HER2-positive resectable primary breast cancer

Region
Japan

Condition
Condition HER2 positive resectable primary breast cancer
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Evaluate effectiveness and safety of Tri-Weekly nab Paclitaxel+Trastuzumab followed by FEC therapy as chemotherapy in preoperation for HER2-positive resectable primary breast cancer.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Pathological complete response rate
Key secondary outcomes Overall response rate
Breast conserving rate
Adverse events

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 Administrate 4 cycles of FEC after 4 cycles of nab Paclitaxel and Trastuzumab. Operation is to be performed after chemotherapy.

nab Paclitaxel and Trastuzumab 4 cycles
nab Paclitaxel 260mg/m2 iv day1 q3w
Trastuzumab 6 mg/kg iv day1 q3w
(8 mg/kg in only first course)

FEC 4 cycles
5-Fluorouracil 500mg/m2 iv day 1 q3w
Epirubicin 100mg/m2 iv day 1 q3w
Cyclophosphamide 500mg/m2 iv day 1 q3w
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 invasive breast cancer
2. Stage I-IIIA (T1c-3, N0-2a,M0)
3. An age of 20 years to 70 years
4. Hormonal receptor status is confirmed.
5. HER2 status, is confirmed.
1)IHC 3+
2) FISH score>2.2
6. PS 0-1
7. Measurable lesion according to RECIST standard
8. No prior treatment for breast cancer
9. LVEF more than 55%
10. Adequate EKG

11. Required baseline laboratory data
WBC > 4,000/mm3
Neut > 2,000/mm3
PLT > 100,000/mm3
Hb > 9.0g/dl
AST < ULNx2.5
ALT< ULNx2.5
T-Bil < 1.5mg/dl
Serum creatinin < 1.5mg/dl
12. Written informed consent
Key exclusion criteria 1. Current history of malignant neoplasm.
2. Bilateral invasive breast cancer.
3. Cases who does not wish to undergo an operation after neoadjuvant chemotherapy.
4. Patients with medical conditions that renders them intolerant to primary chemotherapy and related treatment, including infection, diarrhea, intestinal paralysis, severe Diabetes Mellitus.
5. Has history of hypersensitivity reaction in important drug of this study.
6. Positive for HBs antigen.
7.
8. With severe peripheral neuropathy.
9. Transfusion within the past 2 weeks.
10. With the history of severe mental disease or under treatment.
11. With active pleural effusion or ascites.
12. Pregnancy, or suspected pregnancy.
13. Cases who physician judged improper to entry this trial.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinya Tokunaga
Organization Osaka City General Hospital
Division name Department of Medical Oncology
Zip code
Address 2-13-22, Miyakojima-hondori, Miyakojima-ku, Osaka, Japan
TEL 06-6929-1221
Email s-tokunaga@med.osakacity-hp.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shinya Tokunaga
Organization Osaka City General Hospital
Division name Department of Medical Oncology
Zip code
Address 2-13-22, Miyakojima-hondori, Miyakojima-ku, Osaka, Japan
TEL 06-6929-1221
Homepage URL
Email s-tokunaga@med.osakacity-hp.or.jp

Sponsor
Institute Osaka Breast Cancer Chemo-Endocrine Therapy Study Group
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
2012 Year 07 Month 18 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 Completed
Date of protocol fixation
2012 Year 04 Month 26 Day
Date of IRB
Anticipated trial start date
2012 Year 06 Month 01 Day
Last follow-up date
2017 Year 04 Month 30 Day
Date of closure to data entry
2018 Year 04 Month 30 Day
Date trial data considered complete
2018 Year 04 Month 30 Day
Date analysis concluded
2018 Year 04 Month 30 Day

Other
Other related information

Management information
Registered date
2012 Year 07 Month 18 Day
Last modified on
2018 Year 07 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009814

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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