UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019377 |
|---|---|
| Receipt number | R000022405 |
| Scientific Title | An Exploratory phase II Study of Eribrin rechallenge after short term therapy of 5-FU for HER2 negative, advanced/recurrent breast cancer. |
| Date of disclosure of the study information | 2015/10/16 |
| Last modified on | 2015/10/19 15:37:57 |
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Basic information
Public title
An Exploratory phase II Study of Eribrin rechallenge after short term therapy of 5-FU for HER2 negative, advanced/recurrent breast cancer.
Acronym
An Exploratory phase II Study of Eribrin rechallenge after short term therapy of 5-FU for HER2 negative, advanced/recurrent breast cancer.(HARCAS Study)
Scientific Title
An Exploratory phase II Study of Eribrin rechallenge after short term therapy of 5-FU for HER2 negative, advanced/recurrent breast cancer.
Scientific Title:Acronym
An Exploratory phase II Study of Eribrin rechallenge after short term therapy of 5-FU for HER2 negative, advanced/recurrent breast cancer.(HARCAS Study)
Region
| Japan |
Condition
Condition
HER2 negative, Advanced and recurrent breast cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate efficacy of rechallenge of Eribrin for advanced/recurrent breast cancer patients who received prior Eribrin treatment.
And to evaluate extension of disease control period this rechallenge therapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Progression free survival in Eribrin rechallenging phase
Key secondary outcomes
Safety, Disease control rate of Eribrin rechallenging phase, Time to Failure of Strategy, Overall response rate after 1 cycle of S-1 therapy, Overall survival
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
Eribulin will be reintroduced after short term S-1 treatment against the patients who have ceased prior Eribulin as 1st line chemotherapy before disease progression.
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
| Not applicable |
Gender
Female
Key inclusion criteria
1.Pathologically confirmed primary breast cancer
2.Woman equal or more than 20years old
3.Inoperable or recurrent breast cancer (expect for Stage3disease)
4.HER2-negative by IHC or FISH
5.ECOG performance status 0-2 at the registration
6.Without prior cytotoxic chemotherapy for inoperable or recurrent breast cancer
7.Patients with measurable lesion
8.Organ functions satisfies all the conditions below (within a month before registration)
neutrophil >=1,500/mm3
Plt >=75,000/mm3
Hb >=8.0g/dL
AST and ALT <=100IU/L, (AST and ALT>=300IU/L, if patients have liver metastasis)
total bilirubin >=2.0mg/dL
creatinine clearance >=60 ml/min
9.Informed consent is obtainable from the patient herself in documented form.
Key exclusion criteria
1.Patient with active infection
2.brain metastasis with clinical symptoms
3.Pregnant, lactating, or intends to become pregnant
4.History of hypersensitivity to a protocol treatment drug or a vehicle in the drug preparation.
5.Active multiple primary cancer (heterochronous multiple cancers that are concurrent, where the cancer-free period is also less than 5 years.
Carcinoma in situ deemed to be cured by local treatment (lesions that are intraepithelial carcinoma or mucosal cancer) is not included as an active multiple cancer.
6.Extensive liver metastases, or lymphangitic lung metastasis with accompanying dyspnea.
7.Only 1 lesion that is a target of evaluation, with a history of radiotherapy having been performed on the same site.
8.Pleural effusion, ascites, or pericardial effusion that required emergency treatment.
9.Interstitial pneumonia or pulmonary fibrosis
10.Positive for HBs antigen
11.Uncontrolled diabetes mellitus
12.Study participation is difficult due to mental illness or psychiatric symptoms.
13.Patient is deemed unsuitable for study participation by an investigator.
Target sample size
33
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tsutomu Takashima |
Organization
Osaka City University Graduate school of Medicine
Division name
Department of Surgical Oncology
Zip code
Address
1-5-7 Asahimachi, abeno, Osaka City, Osaka,Japan
TEL
06-6645-2346
Harcas-study@inc-re.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsutomu Takashima |
Organization
Osaka City University Graduate school of Medicine
Division name
Department of Surgical oncology
Zip code
Address
1-5-7 Asahimachi, abeno, Osaka City, Osaka,Japan
TEL
06-6645-2346
Homepage URL
Harcas-study@inc-re.com
Sponsor or person
Institute
Osaka Breast Cancer Chemo-Endocrine Therapy Study Group
Institute
Department
Personal name
Funding Source
Organization
Eisai Co., Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 10 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2015 | Year | 07 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 08 | Month | 26 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 10 | Month | 16 | Day |
Last modified on
| 2015 | Year | 10 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022405
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