UMIN-CTR Clinical Trial

Public title

Phase I Clinical Study of Combination Therapy with Eribulin and Gemcitabine in Patients with Progressive Recurring Breast Cancer (JBCRG-18Gem)

Acronym

JBCRG-18Gem

Scientific Title

Phase I Clinical Study of Combination Therapy with Eribulin and Gemcitabine in Patients with Progressive Recurring Breast Cancer (JBCRG-18Gem)

Scientific Title:Acronym

JBCRG-18Gem

Region

Japan

Condition

Progressive Recurring Breast Cancer

Classification by specialty

Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

In this clinical study, the maximum tolerated dose (MTD) will be estimated, based on the dose limiting toxicity of the combination therapy of eribulin (HAL) and gemcitabine (GEM) in patients with progressive recurring breast cancer, and the recommended dose (RD) for Phase II clinical study will be determined.

Basic objectives2

Others

Basic objectives -Others

Dosage finding

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Phase I

Primary outcomes

MTD, DLT, RD

Key secondary outcomes

AE, ORR, PK

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

Combined therapy of Eribulin and Gemcitabine

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

70

years-old

>=

Gender

Female

Key inclusion criteria

1) Female patients who were histologically diagnosed with infiltrating breast cancer.
2) Patients with distal metastasis, unresectable local/regional recurrence, and local advanced breast cancer.
3) Patients with ECOG performance status (PS) of 0 to 1.
4) Patients with history of prior treatment with anthracycline and taxane as pre/post-operative treatment or treatment to prevent recurrence.
5) Patients without history of prior treatment with eribulin or gemcitabine.
6) Patients in whom hematological toxicity and non-hematological toxicity regarding DLT are all G1 or lower.
7) Patients without impaired main organ function.
The values of laboratory findings within 14 days prior to registration meet all the criteria listed below.
(1) neutrophil count: >=2,000/mm3
(2) platelet count: >=100,000 mm3
(3) hemoglobin: >=9.0 g/dL
(4) total bilirubin: =<2.0 mg/dL
(5)AST (GOT), ALT (GPT), ALP: =<3 times the upper limit of center standard
(6) serum creatinine =<1.5 mg/dL
8) Patients with life expectancy of 6 months or longer from the start of the administration.
9) Patients submitted written informed consent to participate in this clinical study.
10) Patients at least 20 years of age but not older than 70 at the time of informed consent.

Key exclusion criteria

1) Patients with coexisting infection or cases with pyrexia suspected of infection.
2) Cases with serious drug allergy.
3) Cases with serious renal disorder and hepatic disorder (jaundice).
4) Cases with clear indications of interstitial pneumonia or pulmonary fibrosis in chest X-ray.
5) Cases with large pleural/peritoneal effusion (patients required drainage)
6) Cases with poorly-controlled hypertension and diabetes mellitus.
7) Cases with continuous systemic administration (oral or intravenous) of steroid.
8) Pregnant patients or cases with possible pregnancy.
9) Patients with active multiple primary cancer.
10) Cases with preexisting condition of psychiatric disorder or central nervous system disorder.
11) Cases with active brain metastasis.
12) Cases participating in other clinical study.
13) Cases that the investigator (subinvestigator) judged as inappropriate as the subject of this clinical study.
14) Patients with hepatitis B antibody.

Target sample size

9

Name of lead principal investigator

1st name	Hiroji
Middle name
Last name	Iwata

Organization

Aichi Cancer Center Hospital

Division name

Dept. of Breast Oncology

Zip code

464-8681

Address

1-1 Kanokoden, Chikusa-ku, Nagoya 464-8681, Japan

TEL

052-762-6111

Email

hiwata@aichi-cc.jp

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 103-0016, Japan

TEL

03-6264-8873

Homepage URL

https://www.jbcrg.jp/

Email

office@jbcrg.jp

Institute

JBCRG (Japan Breast Cancer Research Group)

Institute

Department

Personal name

Organization

JBCRG (Japan Breast Cancer Research Group)

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

N/A

Address

N/A

Tel

N/A

Email

N/A

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

四国がんセンター(愛媛県)、愛知県がんセンター中央病院(愛知県)、岩手医科大学(岩手県)、都立駒込病院(東京都)、群馬県立がんセンター(群馬県)

Date of disclosure of the study information

2012

Year

12

Month

26

Day

URL releasing protocol

https://upload.umin.ac.jp/cgi-bin/ctr/ctr_up_reg_f5.cgi

Publication of results

Published

URL related to results and publications

http://www.pieronline.jp/content/article/0385-0684/45080/1165

Number of participants that the trial has enrolled

7

Results

Results
Grade 3 or higher hematological toxicities, including neutropenia, frequently occurred, it was difficult to conduct this combination therapy as scheduled. Drug-drug interactions between ERI and GEM were not observed.

Conclusions
The combination therapy with ERI and GEM is tolerated in patients with metastatic breast cancer, and it is crucial to manage hematological toxicities that frequently occur.

Results date posted

2021

Year

07

Month

01

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

2018

Year

08

Month

20

Day

Baseline Characteristics

Metastatic breast cancer

Participant flow

Seven patients were enrolled in this study, 3 patients of whom received the Level 0 doses and the other 4 patients received the Level 1 doses.

Adverse events

A dose limiting toxicity was found in only 1 patients of the Level 1 group (grade 3 oral mucositis).

Outcome measures

The primary endpoint: DLT
The secondary endpoint: Adverse events, ORR and PK

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2012

Year

12

Month

03

Day

Date of IRB

Anticipated trial start date

2012

Year

12

Month

03

Day

Last follow-up date

2014

Year

11

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2012

Year

12

Month

22

Day

Last modified on

2021

Year

07

Month

08

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011224