UMIN-CTR Clinical Trial

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

Breast Cancer

Classification by specialty

Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO

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

Primary outcomes

Pathological complete response rate

Key secondary outcomes

Preserving operation rate, Clinical response rate, Safety, etc.

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Department of Surgery Kurume University School of Medicine

Institute

Department

Personal name

Organization

Kurume University Department of Surgery

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2013

Year

04

Month

16

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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