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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000021398
Receipt No. R000024671
Scientific Title A Phase III, Open Label, Randomized, Controlled, Multicenter Study, comparing Eribulin with S1, to assess Health-related Quality of Life (HRQoL) in the Treatment of Her2 negative Metastatic Breast Cancer Patients
Date of disclosure of the study information 2016/03/16
Last modified on 2020/12/04

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Basic information
Public title A Phase III, Open Label, Randomized, Controlled, Multicenter Study, comparing Eribulin with S1, to assess Health-related Quality of Life (HRQoL) in the Treatment of Her2 negative Metastatic Breast Cancer Patients
Acronym RESQ
Scientific Title A Phase III, Open Label, Randomized, Controlled, Multicenter Study, comparing Eribulin with S1, to assess Health-related Quality of Life (HRQoL) in the Treatment of Her2 negative Metastatic Breast Cancer Patients
Scientific Title:Acronym RESQ
Region
Japan

Condition
Condition metastatic breast cancer
Classification by specialty
Hematology and clinical oncology Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The study was designed to evaluate health related quality of life (HRQoL) of Eribulin compared to S1 for HER2 negative metastatic breast cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase III

Assessment
Primary outcomes HRQoL : health related quality of life
Key secondary outcomes Overall survival, Progression free survival, time to treatment failure, new metastatic free survival, safety, economic evaluation, patient preference

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Eribulin
1.4 mg/m2 IV day1 and day8, q3w

repeated until PD or for at least 6 cycles
Interventions/Control_2 S1
S-1: orally bid, days, 1-14, q3w
Dose according to BSA
<1.25 m2, 80 mg/day
1.25 to 1.5 m2, 100 mg/day
more than 1.5 m2, 120 mg/day

repeated until PD or for at least 6 cycles
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 Key inclusion criteria
1) Histologically proven breast cancer
2) One of the following conditions has to be met for a diagnosis of metastatic breast cancer.
a) At presentation, the patients have distant metastasis.
b) The patient has breast cancer that has worsened or recurred in association with distant metastasis after treatment (after surgery and pre- and post-operative treatment); however, local recurrence is excluded.
3) Patients need to receive chemotherapy for metastatic breast cancer
4) Performance status (ECOG scale): 0-1
5) The presence of at least one measurable lesion. However, sites treated by radiotherapy are not considered assessable lesions.
6) Adequate major organ functions within 14 days before enrollment., as defined below:
Neutrophil count > 1,500/mm3
Platelet count > 100,000/mm3
Hemoglobin > 9.0 g/dL
AST < 100 U/L
ALT < 100 U/L
Total bilirubin < 2.1 mg/dL
Serum creatinine < 1.6 mg/dL and Ccr > 50mL/min
7)A given time has passed from the last treatment.
14 days : irradiation, endocrine therapy and chemotherapy
28 days : surgery
8) Age of 20-75 years.
9) Patients will protect the procedure of the clinical trial.
10) Duration of survival is expected more than six months
11) Written informed consent.
Key exclusion criteria Key exclusion criteria
1) HER2 positive
2) more than two regimens of chemotherapy for metastatic breast cancer
3) Using Eribulin or S1 before enrollment
4) Presence of Grade 3 non hematologic or hematologic toxicities
5) Lung fibrosis, interstitial pneumonitis,
6) severe cardiac dysfunction, ischemic heart disease
7) Severe pleural effusion or ascites
8) The sustained systemic steroid treatment
9) Severe allergic history against medicines
10) Pregnant or the pregnancy is doubted
11) The presence of brain metastasis requiring treatment
12) The presence of other active cancers (synchronous double cancers or metachronous double cancers with a disease-free interval of 5 years or less).
13) Bilateral breast cancer (However, registration is permitted when contralateral breast cancer is DCIS or the status of ER and HER2 is same)
14) Physician concludes that the patient's participation in this trial is inappropriate
Target sample size 330

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masato Takahashi
Organization National Hospital Organization, Hokkaido Cancer Center
Division name Department of Breast Surgery
Zip code
Address 4-2 Kikusui Shiroishiku Sapporo
TEL 011-811-9111
Email masatotk@sap-cc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name CSPOR-BC
Organization CSPOR-BC
Division name secretariat
Zip code
Address 2-18-1 sotokanda chiyodaku tokyo
TEL 03-5294-7288
Homepage URL http://cspor-bc.or.jp/index.html
Email office-bc@cspor-bc.or.jp

Sponsor
Institute CSPOR-BC
Institute
Department

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
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 北海道がんセンター 、国立がん研究センター東病院、聖マリアンナ大学病院、静岡がんセンター、大阪成人病センター、広島市民病院ほか

Other administrative information
Date of disclosure of the study information
2016 Year 03 Month 16 Day

Related information
URL releasing protocol http://cspor-bc.or.jp/study/index.html
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 No longer recruiting
Date of protocol fixation
2016 Year 02 Month 04 Day
Date of IRB
2016 Year 05 Month 12 Day
Anticipated trial start date
2016 Year 06 Month 01 Day
Last follow-up date
2021 Year 04 Month 01 Day
Date of closure to data entry
2021 Year 05 Month 31 Day
Date trial data considered complete
2021 Year 06 Month 30 Day
Date analysis concluded
2021 Year 09 Month 30 Day

Other
Other related information

Management information
Registered date
2016 Year 03 Month 08 Day
Last modified on
2020 Year 12 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024671

Research Plan
Registered date File name
2016/06/10 RESQ_Protocol_ver1.1.pdf

Research case data specifications
Registered date File name

Research case data
Registered date File name


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