UMIN-CTR Clinical Trial

Public title

Evaluation of safety and efficacy of eribulin for patients advanced or recurrent HER2 negative breast cancer who have been treated with anthracyclines and taxanes

Acronym

KBC-SG1105

Scientific Title

Evaluation of safety and efficacy of eribulin for patients advanced or recurrent HER2 negative breast cancer who have been treated with anthracyclines and taxanes

Scientific Title:Acronym

KBC-SG1105

Region

Japan

Condition

Breast cancer

Classification by specialty

Hematology and clinical oncology	Surgery in general	Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

This study is to evaluated the efficacy and safety of eribulin for the HER2 negative advanced or recurrent breast cancer patients who had received anthracyclines and taxanes and the additional 2 regimens after relapse.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Primary outcomes

overall response rate

Key secondary outcomes

duration of response
progression- free survival
overall survival

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

eriburin 1.4mg/m2 day1,8 iv every 3 weeks, until progressive

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

Age-lower limit

20

years-old

<=

Age-upper limit

75

years-old

>=

Gender

Female

Key inclusion criteria

1.advanced or recurrent breast cancer
2.ECOG performance status 0-2
3.Her2 negative
4.aged from 20 years to 75 years
5.no treatment period prior to study
chemotherapy- 4 weeks(two weeks of no treatment are acceptable if prior treatment is not considered to affect the study, e.g. antimetabolites)
endocrinethrapy, radiation therapy- 2 weeks
6.having measurable lesion according to RECIST
7.previous treatment with anthracyclines and taxanes
8.previously untreated with eribulin
9.suffient organ function(e.g. bone marrow, cardiac, liver and kidney)
10.no significant abnormal EKG
11.written informed consent

Key exclusion criteria

1 ineligible patients complicated with infectious diseases or who suspected infectious diseases with fever
2. diarrheal , ileus
3. GI bleeding
4.severe drug allergy
5. severe renal and/ or liver dysfunction
6.significant interstitial pneumonia or pulmonary fibrosis by chest radiograph
7.pleural effusion, peritoneal effusion
8.poorly controlled hypertension or diabetes mellitus
9.maintenance therapy with systemic corticosteroids
10.pregnant women or women with suspected pregnancy
11.patients who received blood transfusion, blood products or G-CSF within 7 days prior to this study
12.presence of the active other malignancies
13.severe psychiatric disorder
14 brain metastases
15.patients judged by the investigator to be unfit for the study

Target sample size

50

Name of lead principal investigator

1st name
Middle name
Last name	Shigeto Maeda

Organization

National Hospital Organization Nagasaki Medical Center

Division name

Surgery

Zip code

Address

2-1001-1, Kubara, Ohmura, Nagasaki

TEL

0957-52-3121

Email

maedash@nagasaki-mc.com

Name of contact person

1st name
Middle name
Last name	Kazuo Tamura

Organization

Kyushu Breast Cancer Study Group

Division name

Exective office

Zip code

Address

7-45-1, Nanakuma, Jonan-ku, Fukuoka

TEL

092-801-2845

Homepage URL

http://www.chotsg.com/

Email

kbcsg@chotsg.com

Institute

Kyushu Breast Cancer Study Group

Institute

Department

Personal name

Organization

Non-profit Organization Clinical Hematology/Oncology Study Group

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

国立病院機構長崎医療センター、日本赤十字社長崎原爆病院、長崎市立市民病院、長崎大学病院（長崎県）、うえお乳腺外科、別府医療センター、大分県立病院（大分県）、熊本市民病院、熊本赤十字病院（熊本県）、佐賀大学医学部附属病院（佐賀県）北九州市立医療センター、福岡大学病院、戸畑共立病院、聖マリア病院、社会保険久留米第一病院、九州がんセンター、博愛会病院（福岡県）、関門医療センター（山口県）、博愛会相良病院（鹿児島県）、県立宮崎病院（宮崎県）、大阪労災病院、市立吹田市民病院、りんくう総合医療センター（大阪府）

Date of disclosure of the study information

2012

Year

01

Month

24

Day

URL releasing protocol

http://www.chotsg.com/

Publication of results

Published

URL related to results and publications

http://creativecommons.org/licenses/by-nc-nd/4.0/

Number of participants that the trial has enrolled

47

Results

ORR was 17.0%, DCR 66.0%, median PFS 4.9 months, DOR 6.6 months, and OS 17.4 months. Common grade 3/4 AEs included neutropenia (53.2%), leukopenia (42.1%), and febrile neutropenia (8.5%), with no increase in toxicity during long-term use. First-line therapy showed better response and survival than later lines, while AE incidence was similar. Eribulin demonstrated efficacy and tolerability in Japanese women with MBC across first- to third-line settings.

Results date posted

2025

Year

12

Month

03

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

The median age was 54 years (range, 31-75 years) and median number of prior chemotherapy regimens for MBC was one (range, 0-2 regimens).
Menopause,37 patients (78.7%),ECOG performance status:PS0; 34 (72.3%), PS1; 13(27.7), Estrogen receptor status: Positive 35 (74.5), Negative 12 (25.5), Previous anticancer therapy for MBC: 0; 23 (48.9), 1; 14 (29.8), 2; 10 (21.3),Prior chemotherapy: Taxanes 47 (100.0), anthracyclines 47 (100.0), Prior endocrine therapy: 35 (74.5), Prior radiation therapy, 23 (48.9)

Participant flow

Among those patients, 23(48.9%) received eribulin as first-line therapy. During the study, GCSF was administered to two patients (4.3%).
Eribulin was administered for a median of 7.7 cycles, and its median dose intensity and relative dose intensity for the first six cycles was 0.8 mg/m2/week and 86%, respectively. Twenty-four patients (51.1%) discontinued administration of eribulin during the study because of disease progression (16 patients), AEs (5 patients), or delayed schedule (3 patients).

Adverse events

The most common hematological AEs of any grade were neutropenia (100%), leucopenia (80.9%), anemia (48.9%) and thrombocytopenia (21.3%), while nonhematological AEs of any grade were alopecia (85.1%), fatigue (63.8%), and anorexia (51.1%). The most common grade 3/4 adverse events were neutropenia (25 patients; 53.2%), leukopenia (16 patients; 42.1%), febrile neutropenia (4 patients; 8.5%), fatigue, anorexia, and peripheral sensory neuropathy (2 patients each; 4.3%), as well as AST and ALT elevations in 2 and 3 patients(6.4%), respectively.

Outcome measures

The primary objective, ORR (95% CI), was 17.0% (7.6-30.8). DCR was 66.0% (51.2-77.8). The estimated median PFS was 4.9 months (3.5-7.0), the estimated median DOR was 6.6 months (1.9-14.3), and the estimated median OS was 17.4 months (10.1-not evaluable).

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2011

Year

12

Month

14

Day

Date of IRB

Anticipated trial start date

2012

Year

01

Month

01

Day

Last follow-up date

2014

Year

11

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2012

Year

01

Month

23

Day

Last modified on

2025

Year

12

Month

03

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008341