UMIN-CTR Clinical Trial

Public title

Exploratory study to determine predictive factors of effectiveness of nab-paclitaxel in breast cancer (Expect study)

Acronym

Exploratory study to determine predictive factors of effectiveness of nab-paclitaxel in breast cancer (Expect study)

Scientific Title

Exploratory study to determine predictive factors of effectiveness of nab-paclitaxel in breast cancer (Expect study)

Scientific Title:Acronym

Exploratory study to determine predictive factors of effectiveness of nab-paclitaxel in breast cancer (Expect study)

Region

Japan

Condition

Breast cancer

Classification by specialty

Breast surgery

Classification by malignancy

Malignancy

Genomic information

YES

Narrative objectives1

The purpose of this study is to determine predictive factors of nab-paclitaxel by evaluating the correlation with biomarker in the tumor tissues and clinical effect for early-stage or stage IV breast cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

Correlativity of the biomarker and Response Rate

Key secondary outcomes

Rasponse rate,Pathological response rate, Safty

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

Nab-paclitaxel
Nab-paclitaxel:100mg/m2 i.v weekly for 12 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

80

years-old

>=

Gender

Female

Key inclusion criteria

1.Histologically confirmed Breast cancer
2.Clinical stage2-4
3.Has measurable region
4.Age >=20 and 80=<
5.No prior surgery, radiation, chemotherapy and endcrinethrapy
6.Presence of measurable lesion
7.Required baseline laboratory parameters (within 14 days before registration):
Hb more than 9.0g/dl
WBC >= 3000 /mm3 and <= 12,000 /mm3
Neu >= 1500 / mm3
Plt >= 75,000/mm3
T-Bil <= 2.5 times ULM
AST<= ULNx2.5
ALT<= ULNx2.5
Creatinine <=1.5 mg/dL
8.Performance status 0-2
9.Written IC

Key exclusion criteria

1.History of hypersensitivity reaction
2.HER2 positive confirmed by IHC or FISH
3. Active another cancer
4.Other severe complications, such as infection, diarrhea, intestinal tract paralysis, ileus, uncontrollable diabetes,uncontrollable angina, myocardial infarction within 6 months, heart failure, Pulmonary fibrosis or interstitial pneumonia, cerebrovascular disorder
5.With symptomatic brain cancer
6.With mental disorder which become problem on clinical practice
7.With serious bone marrow suppression, a renal damage, a liver damage
8.With serious pleural effusion or ascites
9.With infection or febrile infection
10. Hypersensitivity reaction of nab-paclitaxel or paclitaxel
11.During administration of flucytosine, phenytoin, warfarin potassium
8. Physician judged improper to entry this trial

Target sample size

40

Name of lead principal investigator

1st name	Yasushi
Middle name
Last name	Okamoto

Organization

Toho University School of Medicine, Medical Center, Ohashi Hospital

Division name

Breast cancer center

Zip code

1538515

Address

2-17-6,Ohashi,Meguro-ku,Tokyo 153-0044,Japan

TEL

03-3468-1251

Email

yok195@med.toho-u.ac.jp

Name of contact person

1st name	YASUSHI
Middle name
Last name	OKAMOTO

Organization

Toho University School of Medicine, Medical Center, Ohashi Hospita

Division name

Breast cancer center

Zip code

1538515

Address

2-17-6,Ohashi,Meguro-ku,Tokyo 153-0044,Japan

TEL

03-3468-1251

Homepage URL

Email

yok195@med.toho-u.ac.jp

Institute

Toho University School of Medicine, Medical Center, Ohashi Hospital

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Toho University School of Medicine, Medical Center, Ohashi Hospital

Address

2-17-6,Ohashi,Meguro-ku,Tokyo 153-0044,Japan

Tel

03-3468-1251

Email

secretary@oha.toho-u.ac.jp

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

2012

Year

12

Month

11

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

Open public recruiting

Date of protocol fixation

2012

Year

10

Month

01

Day

Date of IRB

2012

Year

10

Month

01

Day

Anticipated trial start date

2012

Year

12

Month

11

Day

Last follow-up date

2018

Year

12

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2012

Year

12

Month

11

Day

Last modified on

2019

Year

04

Month

25

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010936