UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II clinical trial of the combination of eribulin and trastuzumab for advanced/recurrent HER2-positive breast cancer: observational study
Title of the study (Brief title)	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	Koichi Sakaguchi
Organization	Kyoto Prefectural University of Medicine
Division name	Endocrine & Breast Surgery
Address	465 Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto
TEL	075-251-5534
Email	ksak@koto.kpu-m.ac.jp

Public contact
Name of contact person	Koichi Sakaguchi
Organization	Kyoto Prefectural University of Medicine
Division name	Endocrine & Breast Surgery
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 02 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000032729