UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010504 |
|---|---|
| Receipt number | R000012286 |
| Scientific Title | Phase II study of neoadjuvant chemotherapy with the FEC followed by weekly nab-Paclitaxel(nanoparticle albumin-bound paclitaxel) for the operable breast cancer (KSCOG-BC07) |
| Date of disclosure of the study information | 2013/04/16 |
| Last modified on | 2019/01/08 18:37:25 |
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Basic information
Public title
Phase II study of neoadjuvant chemotherapy with the FEC followed by weekly nab-Paclitaxel(nanoparticle albumin-bound paclitaxel) for the operable breast cancer (KSCOG-BC07)
Acronym
Phase II study of neoadjuvant chemotherapy with the FEC followed by weekly nab-Paclitaxel for the operable breast cancer (KSCOG-BC07)
Scientific Title
Phase II study of neoadjuvant chemotherapy with the FEC followed by weekly nab-Paclitaxel(nanoparticle albumin-bound paclitaxel) for the operable breast cancer (KSCOG-BC07)
Scientific Title:Acronym
Phase II study of neoadjuvant chemotherapy with the FEC followed by weekly nab-Paclitaxel for the operable breast cancer (KSCOG-BC07)
Region
| Japan |
Condition
Condition
Breast Cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and safety of FEC followed by weekly nab-Paclitaxel for the operable breast cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pathological complete response rate
Key secondary outcomes
Preserving operation rate, Clinical response rate, Safety, etc.
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
(FEC100)
Fluorouracil(500mg/m2) day1
Epirubicin(100mg/m2) day1
Cyclophosphamide(500mg/m2) day1
every 3weeks x 4cycles.
(weekly nab-Paclitaxel)
nab-Paclitaxel(100mg/m2) day1,8,15
(HER2 positive)
nab-Paclitaxel(100mg/m2) day1,8,15
Trastuzumab*(2mg/kg) day1,8,15,22
*:4 mg/kg for the initial dosing(day1)
every 4 weeks x 4 cycles.
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
| Not applicable |
Gender
Female
Key inclusion criteria
1)No prior treatment for breast cancer and clinical stage T1-3,N0-2,M0
2)Written informed consent to participate
3)Suitable judgement by physician
4)Histological and/or cytological confirmed breast cancer
5)Age 20 or over
6)Performance status (ECOG) 0-1
7)The below criteria met within 14 days prior to therapy
1 WBC between 4,000/mm3 and 12,000/mm3
2 Granulocyte count 2,000/mm3 or more
3 Platelet count 100,000/mm3 or over
4 Hb 9.0 g/dl or more
5 AST and ALT ULNx2.0 or less
6 Total bilirubin 1.5 mg/dL or less
7 Serum creatinine 1.5 mg/dl or less
8 ECG normal
9 Left ventricle ejection fraction 55 % or more by cardiac sonography or MUGA scan
Key exclusion criteria
1)Heart failure with clinically problem or history of cardiac dysfunction
2)Severe complication (uncontrolled diabetes, hypertension, renal failure, hepatic failure, Severe Infection and mental disorder which become problem on clinical practice)
3)Pregnancy and lactation or suspected pregnancy
4)Active secondary malignancy (current secondary malignancy or other malignancy within 5 years)
5)Bilateral breast cancer
6)Pulmonary fibrosis or pneumonitis
7)Allergy of the nab-Paclitaxel, Epirubicin,Cyclophosphamide and Fluorouracil
8)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 | Toh Uhi |
Organization
Kurume University School of Medicine
Division name
Department of Surgery
Zip code
Address
67 Asahi-machi,Kurume city,Fukuoka
TEL
0942-31-7566
utoh@med.kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | same as above |
Organization
Kurume University School of Medicine
Division name
Department of Surgery
Zip code
Address
67 Asahi-machi,Kurume city,Fukuoka
TEL
0942-31-7566
Homepage URL
utoh@med.kurume-u.ac.jp
Sponsor or person
Institute
Department of Surgery Kurume University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kurume University Department of Surgery
Organization
Division
Category of Funding Organization
Other
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 | 04 | Month | 16 | 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
| 2013 | Year | 01 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | 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 | 04 | Month | 16 | Day |
Last modified on
| 2019 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012286
