UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009612 |
|---|---|
| Receipt number | R000011224 |
| Scientific Title | Phase I Clinical Study of Combination Therapy with Eribulin and Gemcitabine in Patients with Progressive Recurring Breast Cancer (JBCRG-18Gem) |
| Date of disclosure of the study information | 2012/12/26 |
| Last modified on | 2021/07/08 10:54:20 |
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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
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/
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)、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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011224
