UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034477
Receipt number R000037970
Scientific Title Efficacy and safety of eribulin in combination with trastuzumab and pertuzumab for HER2-positive advanced breast cancer
Date of disclosure of the study information 2018/11/01
Last modified on 2020/10/27 20:33:31

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Basic information

Public title

Efficacy and safety of eribulin in combination with trastuzumab and pertuzumab for HER2-positive advanced breast cancer

Acronym

KOEB2 trial

Scientific Title

Efficacy and safety of eribulin in combination with trastuzumab and pertuzumab for HER2-positive advanced breast cancer

Scientific Title:Acronym

KOEB2 trial

Region

Japan


Condition

Condition

Eligible patients were those with HER2-positive advanced breast cancer who had previously received trastuzumab (HER) + pertuzumab (PER) + taxanes and T-DM1, followed by HER + PER + eribulin.

Classification by specialty

Hematology and clinical oncology Surgery in general Breast surgery
Adult

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To clarify the efficacy and safety of HER + PER + eribulin for patients with HER2-positive advanced breast cancer who had previously received trastuzumab (HER) + pertuzumab (PER) + taxanes and T-DM1.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

overall response rate: ORR

Key secondary outcomes

progression-free survival: PFS
overall survival: OS
adverse events


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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


Not applicable

Age-upper limit


Not applicable

Gender

Female

Key inclusion criteria

1 female patients with diagnosis of breast cancer by histological or cytological examination.
2 ECOG performance status (PS) 0-2
3 with measurable disease lesion by RECIST
4 patients with HER2-positive advanced breast cancer who had previously received trastuzumab (HER) + pertuzumab (PER) + taxanes and T-DM1 (other additional chemotherapy and endocrine therapy is allowed)
5 without previous eribulin treatment
6 with normal organ function
fulfill the criteria below of laboratory data in 7 days before register
6-1. neutrophils: more than 1,500/mm3
6-2. platelets: more than 100,000mm3
6-3. Hb: more than 9.0g/dL
6-4. total bilirubin: less than 2.0 mg/dL
6-5. AST (GOT), ALT (GPT), ALP: less than 2.5 ULN
6-6. serum creatinine: less than 1.5 mg/dL
7 prognosis of more than 3 months is expected
8 no clinical problem with ECG
9 who agreed to register in this trial with written consent

Key exclusion criteria

1 infection
2 severe allergy for medication
3 severe heart, renal, liver dysfunction
4 interstitial pneumonia or pulmonary fibrosis
5 large amount of pleural effusion or ascites
6 hypertension or diabetes that is poorly controlled
7 under steroid therapy
8 pregnant woman
9 who received transfusion, blood products, and hematopoietic factor products within 7 days
10 active double cancer (simultaneous double cancer and metachronous cancer within 5 years except for carcinoma in situ and intramucosal cancer)
11 history of psychiatric or CNS disorders which casts clinical problems
12 diagnosis or suspect of brain metastasis
13 engaging in other clinical trials
14 when responsible doctors made a judgement of inappropriate patient

Target sample size

35


Research contact person

Name of lead principal investigator

1st name Tetsu
Middle name
Last name Hayashida

Organization

Keio University School of Medicine

Division name

Department of Surgery

Zip code

161-8582

Address

35 Shinanomachi Shinjuku, Tokyo, Japan

TEL

03-3353-1211

Email

tetsu@keio.jp


Public contact

Name of contact person

1st name Takamichi
Middle name
Last name Yokoe

Organization

Keio University School of Medicine

Division name

Department of Surgery

Zip code

160-8582

Address

35 Shinanomachi Shinjuku, Tokyo, Japan

TEL

03-3353-1211

Homepage URL


Email

takamichi.yokoe@gmail.com


Sponsor or person

Institute

Keio University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Keio University School of Medicine

Address

35 Shinanomachi Shinjuku, Tokyo, Japan

Tel

03-3353-1211

Email

med-rinri-jimu@adst.keio.ac.jp


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

2018 Year 11 Month 01 Day


Related information

URL releasing protocol


Publication of results

Unpublished


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

Preinitiation

Date of protocol fixation

2018 Year 07 Month 05 Day

Date of IRB


Anticipated trial start date

2018 Year 11 Month 01 Day

Last follow-up date

2025 Year 11 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Registration period: 2 years
Follow-up period: 5 years


Management information

Registered date

2018 Year 10 Month 13 Day

Last modified on

2020 Year 10 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037970


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name