UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028594
Receipt No. R000032729
Scientific Title Phase II clinical trial of the combination of eribulin and trastuzumab for advanced/recurrent HER2-positive breast cancer: observational study
Date of disclosure of the study information 2017/08/09
Last modified on 2018/10/10

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Phase II clinical trial of the combination of eribulin and trastuzumab for advanced/recurrent HER2-positive breast cancer: observational study
Acronym Phase II clinical trial of the combination of eribulin and trastuzumab for advanced/recurrent HER2-positive breast cancer: observational study
Scientific Title Phase II clinical trial of the combination of eribulin and trastuzumab for advanced/recurrent HER2-positive breast cancer: observational study
Scientific Title:Acronym Phase II clinical trial of the combination of eribulin and trastuzumab for advanced/recurrent HER2-positive breast cancer: observational study
Region
Japan

Condition
Condition breast cancer
Classification by specialty
Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Observational study of "Phase II clinical trial of the combination of eribulin and trastuzumab for advanced/recurrent HER2-positive breast cancer"
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Clinical benefit
Key secondary outcomes

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. Females with breast cancer which is confirmed to be invasive breast cancer by histological or cytological examination.
2. Advanced/reccurent HER2-positive breast cancer patients with clinical stage IIIb, IIIc, or IV.
3. Patients not using chemo agents or trastuzumab as 1st line therapy of advanced/reccurent breast cancer.
4. Patients with a lesion allowing RECIST (ver.1.1) measurement by imaging examinations such as CT or MRI.
5. HER2(3+) by immunohistochemical or positive by fluorescence in situ hybridization methods.
6. Patients with a performance status (ECOG) of 0, 1, or 2
7. Left ventricular ejection fraction (LVEF) is equal or greater than 55% measured by cardiac ultrasonography (or MUGA scan).
8. Patients with adequately maintained organ functions and fulfilling the following conditions within 7 days before registration.
(1)Neutrophil>=1,500/mm3
(2)Platelet>=100,000/mm3
(3)Hb>=9.0g/dL
(4)T-BIL<=2.0mg/dL
(5)AST, ALT <=100IU/L
(6)Serum creatinine <= 1.5mg/dL
9. Patients expected to survive for 6 months or more.
10. Patients not have QTc prolongation by electrocardiogram (QTc: less than 470msec).
11. Patients who provided written informed consent by themselves in principle to participate in this trial.
Key exclusion criteria 1. Patients with active double cancer with less than 5years desease free intervals except for dissected carcinoma in situ or intramucosal cancer.
2. Patients with a past history of interstitial pneumonitis, pulmonary fibrosis or severe emphysema.
3. Patients with brain metastases treatment is required at the time of registration.
4. Patients with serious co-morbidities
(1)Uncontrolled diabates
(2)Uncontrolled hypertension
(3)Myocardial infarction within 24 weeks prior to registration, unstable angina, congestive heart failure, myocardial infarction or ventricular arrhythmia requiring medication.
(4)Ischemic heart disease, arrhythmias, valvular disease requiring medication.
(5)Liver dysfunction(jaundice)
(6)Renal dysfunction
(7)Active infection or fever suspicious of infection.
(8)Other serious complications
5. Pregnant women, nursing mothers, women with possibility of pregnancy or women with no intention to contraception.
6. Other patients who were considered by the primary care physician to be inappropriate as subjects of this trial
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koichi Sakaguchi
Organization Kyoto Prefectural University of Medicine
Division name Endocrine & Breast Surgery
Zip code
Address 465 Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto
TEL 075-251-5534
Email ksak@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Koichi Sakaguchi
Organization Kyoto Prefectural University of Medicine
Division name Endocrine & Breast Surgery
Zip code
Address 465 Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto
TEL 075-251-5534
Homepage URL
Email ksak@koto.kpu-m.ac.jp

Sponsor
Institute Dept. of Endocrine & Breast Surgery, Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization Dept. of Endocrine & Breast Surgery, Kyoto Prefectural University of Medicine
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
2017 Year 08 Month 09 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
2017 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Observational study of "Phase II clinical trial of the combination of eribulin and trastuzumab for advanced/recurrent HER2-positive breast cancer ; UMIN000009890"

Management information
Registered date
2017 Year 08 Month 09 Day
Last modified on
2018 Year 10 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032729

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.