UMIN-CTR Clinical Trial

Public title

A study of neoadjuvant nab-paclitaxel followed by FEC for luminal B-like (HER2-negative) and triple-negative breast cancer

Acronym

A study of neoadjuvant nab-paclitaxel followed by FEC for HER2-negative breast cancer

Scientific Title

A study of neoadjuvant nab-paclitaxel followed by FEC for luminal B-like (HER2-negative) and triple-negative breast cancer

Scientific Title:Acronym

A study of neoadjuvant nab-paclitaxel followed by FEC for HER2-negative breast cancer

Region

Japan

Condition

Luminal B-like (HER2-negative) or triple-negative operable 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 efficacy of neoadjuvant nab-paclitaxel followed by FEC and is to fined predictive markers for neoadjuvant chemotherapy and predictive factor for patients after neoadjuvant chemotherapy

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Phase II

Primary outcomes

Pathological complete response rate based on subtype

Key secondary outcomes

Breast conserving rates, response rates, safety, disease-free survival, overall survival, response rates of nab-paclitaxel,safety of nab-paclitaxel and identification of predictive factors for neoadjuvant chemotherapy and prognostic factors for patients after neoajuvant chemotherapy

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

Four cycles of nab-paclitaxel 260 mg/m2 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

70

years-old

>

Gender

Female

Key inclusion criteria

1) Pathologically confirmed breast cancer
2) Clinical T1-3, N0-2, M0 and operable breast cancer after neoadjuvant chemotherapy
3) Luminal B-like(HER2-negative) or Triple-negative breast cancer
4) 20 years old and more than 20 years old, and less than 70 years old
5) mesurable disease (RECIST ver 1.1)
6) No any previous treatment for breast cancer
7) Performance status 0-1
8) keeping majour organ function with all condition below within 2 weeks before enrollment
WBC, > 4000/mm3 and < 12,000
Neutropil, > 2000/mm3
platelets, > 100,000/mm3
Hb 10.0 g/dl
ALT and AST, within 2x UNL
T-bil, < 1.5 mg/dl
Cr, < 1.5 mg/dl
ECG, within normal limit (no severe arrythmia)
UCG and MUGA scan, LVEF < 55%
9) indication for neoajuvant chemotherapy
10) Submission of needle biopsy sample before treatment and surgical specimen after neoajuvant chemotherapy and written informed consent

Key exclusion criteria

1) clinically important cardiac disorder and past history of this
2) Severe medical disorders (uncontrolled DM, hypertension, renal failure, liver failure, clinically significant infection and mental disorders)
3) pregnant and nursing female
4) active double cancer
5) lung fibrosis and intestinal pneumonisa
6) allergy reaction for drugs is using in this study
7) Others

Target sample size

94

Name of lead principal investigator

1st name
Middle name
Last name	YUTAKA YAMAMOTO

Organization

Graduate shool of medical sciences, Kumamoto University

Division name

Department of Breast and Endocrine Surgery

Zip code

Address

1-1-1, Chuo-ku, , Kumamoto,860-8556, Japan

TEL

81-96-373-5521

Email

ys-yama@triton.ocn.ne.jp

Name of contact person

1st name
Middle name
Last name	Kazuo Tamura

Organization

Clinical Hematology Oncology Treatment Study Group

Division name

Kyushu Breast Cancer Study Group

Zip code

Address

1-8-17-204, Watanabe douri, Chuo-ku, Fukuoka, 810-0004, Japan

TEL

81-92-406-4166

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

Kyushu Breast Cancer Study Group (KBC-SG)

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

熊本大学医学部附属病院等

Date of disclosure of the study information

2015

Year

05

Month

25

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

No longer recruiting

Date of protocol fixation

2014

Year

07

Month

03

Day

Date of IRB

Anticipated trial start date

2014

Year

08

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

2015

Year

05

Month

25

Day

Last modified on

2018

Year

01

Month

05

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020489