UMIN-CTR Clinical Trial

Public title

A multicenter study of adjuvant nab-paclitaxel followed by FEC for early breast cancer

Acronym

A study of adjuvant nab-paclitaxel followed by FEC for early breast cancer

Scientific Title

A multicenter study of adjuvant nab-paclitaxel followed by FEC for early breast cancer

Scientific Title:Acronym

A study of adjuvant nab-paclitaxel followed by FEC for early breast cancer

Region

Japan

Condition

Primary breast cancer

Classification by specialty

Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

The aim of this study is to investigate the completion rate and safety of adjuvant nab-paclitaxel followed by FEC

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Developmental phase

Phase II

Primary outcomes

completion rate of treatment

Key secondary outcomes

safety, disease free survival, period until the onset of peripheral neuropathy and period to recovery, QOL related to peripheral neuropathy

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

As adjuvant chemotherapy, 4 cycles of nab-paclitaxel 260 mg/m2(with or without Trastuzumab) every 3 weeks followed by 4 cycles of FEC (5-FU 500 mg/m2, Epirubicin 100 mg/m2, cyclophosphamide 500 mg/m2) 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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Female

Key inclusion criteria

1) Pathologically confirmed breast cancer
2) Curatively resected
3) Age>=20
4) No more than 6 weeks since surgery
5) No prior therapy(except for surgery)
6) Performance status 0-1
7) Adequate function of important organs (within 14 days before registration)
(1). WBC:>=4000/mm3 and <12,000 or
Neutrophil:>=2,000/mm3
(2). Platelet:>=100,000/mm3
(3). Hemoglobin:>=9.0g/dL
(4). T-Bil:<=1.5mg/dL
(5). AST, ALT:<=ULNx2.0
(6). Creatinin:<=1.5mg/dL
(7). UCG or MUGA scan, LVEF < 55%
(8). ECG, within normal limit
8) Written informed consent

Key exclusion criteria

1) Patients with a history of hypersensitivity to paclitaxel and/or albumin
2) Metachronous bilateral breast cancer
3) Inflammatory breast cancer
4) Active double cancer
5) Other severe complications such as infectious diseases, diarrhea, intestinal palsy, intestinal obstruction, uncontrolled diabetes mellitus, uncontrolled angina, myocardial infarction within 6 months and heart failure
6) Pregnant and nursing female
7) Patients with pulmonary fibrosis or interstitial pneumonia
8) Sever bone marrow suppression, renal dysfunction, liver dysfunction
9) History of hypersensitivity reaction
10)Others

Target sample size

60

Name of lead principal investigator

1st name
Middle name
Last name	Takao Miyaguni

Organization

Naha City Hospital

Division name

Department of Surgery

Zip code

Address

2-31-1 Furujima, Naha-City, Okinawa

TEL

098-884-5111

Email

t-miyaguni@nch.naha.okinawa.jp

Name of contact person

1st name
Middle name
Last name	Kazuo Tamura

Organization

Kyushu Breast Cancer Study Group (KBC-SG)

Division name

Executive office

Zip code

Address

1-8-17-204 Watanabe-dori, Chuo-ku, Fukuoka

TEL

092-406-4166

Homepage URL

http://www.chotsg.com/kbc-sg/index.html

Email

kbc@chotsg.com

Institute

Kyushu Breast Cancer Study Group (KBC-SG)

Institute

Department

Personal name

Organization

Non profit organization Clinical hematology oncology study group

Organization

Division

Category of Funding Organization

Self funding

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

2017

Year

11

Month

06

Day

URL releasing protocol

Publication of results

Partially published

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

No longer recruiting

Date of protocol fixation

2014

Year

03

Month

11

Day

Date of IRB

Anticipated trial start date

2014

Year

04

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2017

Year

11

Month

06

Day

Last modified on

2018

Year

11

Month

15

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034083