UMIN-CTR Clinical Trial

Public title

Phase 2 study of neoadjuvant tri-weekly Nab-paclitaxel and Trastuzumab followed by FEC(5-FU/epirubicin/cyclophosphamide) in patients for HER2 positive breast cancer.

Acronym

Phase 2 study of neoadjuvant tri-weekly Nab-paclitaxel and Trastuzumab followed by FEC(5-FU/epirubicin/cyclophosphamide) in patients for HER2 positive breast cancer.

Scientific Title

Phase 2 study of neoadjuvant tri-weekly Nab-paclitaxel and Trastuzumab followed by FEC(5-FU/epirubicin/cyclophosphamide) in patients for HER2 positive breast cancer.

Scientific Title:Acronym

Phase 2 study of neoadjuvant tri-weekly Nab-paclitaxel and Trastuzumab followed by FEC(5-FU/epirubicin/cyclophosphamide) in patients for HER2 positive breast cancer.

Region

Japan

Condition

HER2 positive breast cancer

Classification by specialty

Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

The purpose of this study was to assess the efficacy and safety of nab-paclitaxel and trastuzumab followed by FEC as neoadjuvant chemotherapy for primary breast cancer.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

pathological complete response rate

Key secondary outcomes

Clinical response rate
Histological effect
Breast preserving operation rate
Frequency of side effects

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

4 cycles of nab-paclitaxel and trastuzumab followed by 4 cycles of FEC.
Nab-paclitaxel(nab-paclitaxel: 260mg/m2, iv, day 1 every 3 weeks)
Trastuzumab*(6mg/kg, iv, day1 every 3 weeks)
*:4 mg/kg for the initial dosing(day1)
every 3 weeks x 4 cycles.
FEC (Epirubicin 100 mg/m2 and CPA 500 mg/m2 and 5-FU 500mg/m2 iv,day 1)
every 3 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

75

years-old

>=

Gender

Female

Key inclusion criteria

1) Histological confirmed invasive breast cancer
2) Clinical stage T1-3, N1-3, M0
3) With evaluable tumor lesions
4) HER2 positive (IHC 3+ or IHC2+, FISH +)
5) Age 20 to 75
6) No prior surgery, radiation, chemotherapy and endocrine therapy
7) ECOG performance status 0 - 1
8) preserving the functions of bone marrow, heart, liver, and kidney
granulocyte count 1,500 / mm3 or more
Platelet 100,000/mm3 or more
Hb 9.0g/dl or more
AST(GOT) less than 2.5-times the upper limit of normal
ALT(GPT) less than 2.5-times the upper limit of normal
Total-bilirubin 1.5 mg/dL or less
serum creatinine 1.5 mg/dL or less
9) Signed informed consent of the patient for the registration.

Key exclusion criteria

1) Allergy of the nab-Paclitaxel, Epirubicin,Cyclophosphamide and Fluorouracil
2) Active secondary malignancies
3) Bilateral invasive breast cancer
4) Severe complications (infection, diarrhea, paresis of intestine, obstruction of the intestines, uncontrolled diabetes mellitus, etc.)
5) Positive for HBs antigen and the history of HBV infection
6) Severe heart disease, or the patient who has past history of it
7) Severe mental disease or under treatment
8) Active gastrointestinal tract ulcer or bleeding
9) Severe bone marrow suppression, renal dysfunction, and liver dysfunction
10) Severe pleural effusion or ascites
12) Pregnancy or suspected pregnancy
13) Physician judged improper to entry this trial

Target sample size

35

Name of lead principal investigator

1st name
Middle name
Last name	Masafumi Inokuchi

Organization

Kanazawa University Hospital

Division name

Department of Breast Oncology

Zip code

Address

13-1 Takara-machi, Kanazawa city, Ishikawa

TEL

Email

Name of contact person

1st name
Middle name
Last name

Organization

Kanazawa University

Division name

Department of gastroenterologic and breast surgery

Zip code

Address

TEL

Homepage URL

Email

Institute

Department of gastroenterologic and breast surgery
Kanazawa University,School of Medicine

Institute

Department

Personal name

Organization

None

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

30

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

Enrolling by invitation

Date of protocol fixation

2012

Year

07

Month

26

Day

Date of IRB

Anticipated trial start date

2012

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

2013

Year

04

Month

24

Day

Last modified on

2013

Year

04

Month

21

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012338