UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009886 |
|---|---|
| Receipt number | 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 | 2021/06/29 14:39:42 |
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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
aogi.kenjiro.zx@mail.hosp.go.jp
Public contact
Name of contact person
| 1st name | Jun |
| Middle name | |
| Last name | Fukase |
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
https://www.jbcrg.jp//
office@jbcrg.jp
Sponsor or person
Institute
JBCRG(Japan Breast Cancer Research Group)
Institute
Department
Personal name
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
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
https://upload.umin.ac.jp/cgi-bin/ctr/ctr_up_reg_f5.cgi
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s10147-021-01940-w
Number of participants that the trial has enrolled
72
Results
Results
The median PFS was 6.6 months with eribulin versus 4.2 months with TPC (hazard ratio: 0.72 [95% confidence interval (CI), 0.40-1.30], p = 0.276).
Median TTF was 6.0 months with eribulin versus 3.6 months with TPC (hazard ratio: 0.66 [95% CI, 0.39-1.14], p = 0.136).
Other endpoints were also similar between groups.
Conclusions
Eribulin seemed to improve PFS or TTF compared with TPC without statistical significance. Further validation studies are needed.
Results date posted
| 2021 | Year | 06 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 06 | Month | 20 | Day |
Baseline Characteristics
Patients with HER2-negative breast
cancer who have developed recurrent disease after surgery.
Participant flow
Patients with recurrent HER2-negative breast cancer who had received AT regimens in previous treatment (either neoadjuvant/adjuvant or first-line treatment) were eligible for this phase II study
Adverse events
The most common grade 3 greater than or equal to adverse event was neutropenia (22.2% with eribulin versus 16.1% with TPC).
Outcome measures
The primary endpoint of the study was PFS as assessed using RECIST (Version 1.1). Secondary endpoints included TTF, overall response rate (ORR), response duration, and
frequency of adverse events.
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
| 2021 | Year | 06 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011539
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