UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012018
Receipt number R000014023
Scientific Title Combination therapy of Eribulin, Trastuzumab and Pertuzumab for the treatment of patients with previously treated advanced HER2-positive breast cancer.
Date of disclosure of the study information 2013/10/10
Last modified on 2018/03/19 14:53:24

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Basic information

Public title

Combination therapy of Eribulin, Trastuzumab and Pertuzumab for the treatment of patients with previously treated advanced HER2-positive breast cancer.

Acronym

Combination therapy of Eribulin, Trastuzumab and Pertuzumab for the treatment of patients with previously treated advanced HER2-positive breast cancer.

Scientific Title

Combination therapy of Eribulin, Trastuzumab and Pertuzumab for the treatment of patients with previously treated advanced HER2-positive breast cancer.

Scientific Title:Acronym

Combination therapy of Eribulin, Trastuzumab and Pertuzumab for the treatment of patients with previously treated advanced HER2-positive breast cancer.

Region

Japan


Condition

Condition

Breast cancer

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To assess the safety of combination therapy of Eribulin, Trastuzumab and Pertuzumab for the treatment of patients with previously treated advanced HER2-positive breast cancer.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Safety

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Eribulin, Trastuzumab and Pertuzumab

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



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

80 years-old >=

Gender

Female

Key inclusion criteria

1) Patients with pathologically confirmed metastatic/reccurent breast cancer.
2) HER2 positive.
3) Age >=20 and 80=<
4) Performance status (PS, ECOG scale): 0-2.
5) History of one or more cytotoxic agent and anti-HER2 therapy.
6) Adequate organ functions, measured as follows:
Neutrophils: >= 1,500/mm3
Platelet: >= 100,000/mm3
Total birilbin: <= 1.5 x ULN
AST (GOT): <= 3.0 x ULN
ALT (GPT): <= 3.0 x ULN
Serum creatinine: <= 1.5 x ULN
7) LVEF: >= 50%
8) Written informed consent.

Key exclusion criteria

1) Past history of severe hypersensitivity.
2) History of eribulin use during 6 months prior to consent.
3) Active multiple primary malignancy.
4) Patients with uncontrolled infection.
5) Patient with disease requiring emergent intervention.
6) Patients with progressive brain metastasis requiring treatment during 6 months prior to consent.
7) Patients with severe complications.
8) Pregnant or breastfeeding.
9) Patients who deny contraception during this study.
10) Any other cases that the attending doctor judges not appropriate to enroll to this study.

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Mikiya Ishihara

Organization

Mie University Hospital

Division name

Cancer Center

Zip code


Address

2-174 Edobashi, Tsu, Mie, Japan

TEL

059-231-5296

Email

mishihara@clin.medic.mie-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Mikiya Ishihara

Organization

Mie University Hospital

Division name

Dep. of Hematology and Oncology

Zip code


Address

2-174 Edobashi, Tsu, Mie, Japan

TEL

059-232-1111

Homepage URL


Email

mishihara@clin.medic.mie-u.ac.jp


Sponsor or person

Institute

Mie University Hospital

Institute

Department

Personal name



Funding Source

Organization

Mie University Hospital
Dep. of Hematology and Oncology

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2013 Year 10 Month 10 Day


Related information

URL releasing protocol


Publication of results

Published


Result

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



Progress

Recruitment status

Completed

Date of protocol fixation

2013 Year 09 Month 10 Day

Date of IRB


Anticipated trial start date

2013 Year 10 Month 10 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 10 Month 10 Day

Last modified on

2018 Year 03 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014023


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name