UMIN-CTR Clinical Trial

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