UMIN-CTR Clinical Trial

Basic information
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
Condition	Progressive Recurring Breast Cancer
Classification by specialty	Breast surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
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

Assessment
Primary outcomes	MTD, DLT, RD
Key secondary outcomes	AE, ORR, PK

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
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

Research contact person
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

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 103-0016, 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)、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)

Other administrative information
Date of disclosure of the study information	2012 Year 12 Month 26 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	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

Progress
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
Other related information

Management information
Registered date	2012 Year 12 Month 22 Day
Last modified on	2021 Year 07 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011224