UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009716
Receipt number R000011392
Scientific Title Phase I trial of eribulin/S-1 combination therapy for advanced/recurrent breast cancer pretreated by anthracycline and taxane
Date of disclosure of the study information 2013/01/07
Last modified on 2013/01/07 17:50:05

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Basic information

Public title

Phase I trial of eribulin/S-1 combination therapy for advanced/recurrent breast cancer pretreated by anthracycline and taxane

Acronym

Phase I trial of eribulin/S-1 combination therapy for advanced/recurrent breast cancer pretreated by anthracycline and taxane

Scientific Title

Phase I trial of eribulin/S-1 combination therapy for advanced/recurrent breast cancer pretreated by anthracycline and taxane

Scientific Title:Acronym

Phase I trial of eribulin/S-1 combination therapy for advanced/recurrent breast cancer pretreated by anthracycline and taxane

Region

Japan


Condition

Condition

Advanced and recurrent breast cancer

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The maximum tolerated dose (MTD) will be estimated, based on the dose limiting toxicity of the combination therapy of eribulin and S1 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

DLT;Dose Limiting Toxicity
MTD;Maximum Tolerated Dose

Key secondary outcomes

Overall response rate, Progression free survival, Adverse Event


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

Combination therapy of Eribulin and S1

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

75 years-old >

Gender

Female

Key inclusion criteria

(1)histlogically or cytologically confirmed breast cancer.
(2) patients with history of prior treatment with anthracycline and taxane as pre/post-operative treatment or treatment to prevent recurrence.
(3) patients without history of prior treatment with eribulin and S1.
(4) patients at least 20 years of age but not older than 75 at the time of informed.
(5) ECOG perfomance status 0-1.
(6) patients with evaluable lesion by RECIST criteria.
(7) required baseline laboratory parameters (within 2 weeks before registration)
WBC >3,000/mm3 , neutrophil >1,500/mm3
Plt >100,000/mm3
Hb >9.0g/dL
AST and ALT <=100IU/L
total bilirubin <=1.5mg/dL
creatinine clearance <=60 ml/min
(8) no carry-over effect or side effect that could affect the study outcome of prior treatment (without alopecia and neuropathy of grade 1).
(9) written informed consent was obtained
(10) with life expectancy greater than 3 months.

Key exclusion criteria

(1) with symptoms of infectious disease
(2) pleural effusion, peritoneal effusion which needs drainage
(3) brain metastasis with the necessity of treatment
(4) patients with following serious complication
1) Ischemic heart disease and arrhythmic cardiac disease with poor control.
2) ischemic heart disease within 6 months,
3) liver cirrhosis,
4) watery diarrhea
5) interstitial pneumonia or pulmonary fibrosis by chest radiograph
6) bleeding tendency
7) another serious complication
(5) patients who need to receive continuous corticosteroid administration
(6) positive for HBs antigen
(7) patients who treated by widespread radiation therapy
(8) pregnant or nursing women
(9) patients who are participating in the other clinical trial
(10) patients who judged improper to entry this trial by physician

Target sample size

12


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazuhiko Nakagawa

Organization

Kinki University Hospital, Faculty of medicine

Division name

Depertment of medical oncology

Zip code


Address

377-2 Ohnohigashi, Osakasayama City, Osaka, Japan

TEL

072-366-0221

Email



Public contact

Name of contact person

1st name
Middle name
Last name Junji Tsurutani

Organization

Kinki University Hospital, Faculty of medicine

Division name

Depertment of medical oncology

Zip code


Address

377-2 Ohnohigashi, Osakasayama City, Osaka, Japan

TEL

072-366-0221

Homepage URL


Email



Sponsor or person

Institute

Depertment of medical oncology, Kinki University Hospital, Faculty of medicine

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2013 Year 01 Month 07 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

2012 Year 12 Month 19 Day

Date of IRB


Anticipated trial start date

2013 Year 01 Month 07 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

2013 Year 01 Month 07 Day

Last modified on

2013 Year 01 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011392


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name