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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010504
Receipt No. 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

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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
Email 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
Email utoh@med.kurume-u.ac.jp

Sponsor
Institute Department of Surgery Kurume University School of Medicine
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012286

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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