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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009886
Receipt No. R000011539
Scientific Title Study on the clinical efficacy of Eribulin as the first- or second-line treatment in patients with recurrent HER2- negative breast cancer (randomized Phase II study)(JBCRG-19)
Date of disclosure of the study information 2013/02/01
Last modified on 2019/09/05

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Basic information
Public title Study on the clinical efficacy of Eribulin as the first- or second-line treatment in patients with recurrent HER2- negative breast cancer (randomized Phase II study)(JBCRG-19)
Acronym JBCRG-19
Scientific Title Study on the clinical efficacy of Eribulin as the first- or second-line treatment in patients with recurrent HER2- negative breast cancer (randomized Phase II study)(JBCRG-19)
Scientific Title:Acronym JBCRG-19
Region
Japan

Condition
Condition Patients with recurrent HER2-negative breast cancer with a history of neoadjuvant or adjuvant therapy with anthracyclines and taxanes with no or one prior metastatic breast cancer chemotherapy regimens. Prior hormonal therapy for metastatic breast cancer is permitted.
Classification by specialty
Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Progression-free survival (PFS) with Eribulin as the first- or second-line line therapy is examined in patients with recurrent HER2- negative breast cancer, and the clinical efficacy of Eribulin is shown by comparing it with treatment of the physician's choice (TPC).
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes PFS (progression free survival)
Key secondary outcomes 1)TTF(time to treatment failure)
2)Response rate and response duration
3)Frequency of incidence of adverse events
4)Treatment continuation at 6 months after the start of treatment
5)Time and duration of the incidence of adverse events leading to reduction in QOL (peripheral neuropathy, edema, and skin manifestations)

Exploratory endpoints:
1)Type (drug name), PFS and response rate of secondary and tertiary treatment
2)OS (overall survival)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Eriburin
Interventions/Control_2 Paclitaxel, Docetaxel, nab- Paclitaxel, Vinorelbine (An inhibitor of microtubule dynamics was used in the TPC group)
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 a histological diagnosis of invasive breast cancer.
2) Recurrent HER2-negative breast cancer
3) ECOG performance status(PS)0 - 1.
4) Patients with measurable lesions by RECIST.
5) Patients with a history of neoadjuvant or adjuvant therapy with anthracyclines and taxanes. Patients at least 6 months after neoadjuvant or adjuvant therapy in case of taxanes.
6) Patients in whom Eribulin has not been used in the pretreatment.
7) Patients with no or one prior metastatic breast cancer chemotherapy regimens.
8) Patients in whom the major organ functions have been maintained.
The criteria listed below are all met within 14 days before enrollment.
(1) Neutrophil count: At least 1,500/mm3
(2) Platelet count: At least 100,000 mm3
(3) Hemoglobin: At least 9.0 g/dL
(4) Total bilirubin: Not exceeding 2.0 mg/dL
(5) AST (GOT) and ALT (GPT): Under 100 IU/L(Under 150 IU/L for patients who has hepatic metastasis)
(6) Serum creatinine: Not exceeding 1.5 mg/dL
9) Patients with no clinical problems on electrocardiography.
10) Patients from whom written consent for participation in the study has been obtained in person.
Key exclusion criteria 1) Patients with infectious complications, or with a fever and suspected infection.
2) Patients with a severe drug allergy.
3) Patients with severe renal impairment or hepatic dysfunction (jaundice).
4) Patients with clear interstitial pneumonia or pulmonary fibrosis on chest X-ray.
5) Patients with a large amount of pleural effusion or ascites (patients who need drainage)
6) Patients with poorly controlled hypertension or diabetes.
7) Patients who have undergone continuous and systemic administration of steroids (oral or intravenous).
8) Pregnant patients or patients who may be pregnant.
9) Active multiple primary cancers.
10) Patients with a history of a psychiatric disorder that causes a clinical problem, or a central nervous system disorder.
11) Patients with active brain metastasis.
12) Patients who are receiving another treatment at the time.
13) Patients who are judged to be unsuitable as a subject of the treatment by the investigator (subinvestigator) (including those with significant disease progression or cases that are likely to develop a life-threatening condition if a response is not immediately obtained).
Target sample size 80

Research contact person
Name of lead principal investigator
1st name Kenjiro
Middle name
Last name Aogi
Organization Shikoku Cancer Center
Division name Department of Breast and Endocrine Surgery
Zip code 791-0280
Address 160 Koh MinamiUmemotocho, Matsuyama, Ehime, Japan
TEL 089-999-1111
Email aogi.kenjiro.zx@mail.hosp.go.jp

Public contact
Name of contact person
1st name Katsumasa
Middle name
Last name Kuroi
Organization JBCRG(Japan Breast Cancer Research Group)
Division name Head Office
Zip code 103-0016
Address 9-4-3F, Nihonbashikoamicho, Chuo-ku, Tokyo, Japan
TEL 03-6264-8873
Homepage URL http://www.jbcrg.jp//
Email office@jbcrg.jp

Sponsor
Institute JBCRG(Japan Breast Cancer Research Group)
Institute
Department

Funding Source
Organization JBCRG(Japan Breast Cancer Research Group)
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization N/A
Address N/A
Tel N/A
Email N/A

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 四国がんセンター(愛媛県)、大阪労災病院(大阪府)、公立那賀病院(和歌山県)、北海道がんセンター(北海道)、虎の門病院(東京都)、都立駒込病院(東京都)、さいたま赤十字病院(埼玉県)、青森県立中央病院(青森県)、久留米大学病院(福岡県)、千葉大学医学部附属病院(千葉県)、手稲渓仁会病院(北海道)、旭川厚生病院(北海道)、広島市立広島市民病院(広島県)、関西電力病院(大阪府)、旭川医科大学病院(北海道)、愛知県がんセンター中央病院(愛知県)、大阪医療センター(大阪府)、静岡県立総合病院(静岡県)、鹿児島大学病院(鹿児島県)、熊本大学医学部附属病院(熊本県)、高知医療センター(高知県)

Other administrative information
Date of disclosure of the study information
2013 Year 02 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 72
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 01 Month 21 Day
Date of IRB
2013 Year 04 Month 16 Day
Anticipated trial start date
2013 Year 05 Month 14 Day
Last follow-up date
2018 Year 11 Month 10 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 01 Month 28 Day
Last modified on
2019 Year 09 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011539

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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