UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021398 |
|---|---|
| Receipt number | 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 | 2024/02/08 18:19:56 |
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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 | Masato |
| Middle name | |
| Last name | Takahashi |
Organization
National Hospital Organization, Hokkaido Cancer Center
Division name
Department of Breast Surgery
Zip code
003-0804
Address
4-2 Kikusui Shiroishiku Sapporo
TEL
011-811-9111
masatotk@sap-cc.go.jp
Public contact
Name of contact person
| 1st name | CSPOR-BC |
| Middle name | |
| Last name | CSPOR-BC |
Organization
CSPOR-BC
Division name
secretariat
Zip code
277-0871
Address
Satellite no.502 in front of Kashiwanoha Campus, The University of Tokyo, 178-4-4 Wakashiba, Kashiwa
TEL
04-7135-5609
Homepage URL
http://cspor-bc.or.jp/index.html
office-bc@cspor-bc.or.jp
Sponsor or person
Institute
CSPOR-BC
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
CSPOR-BC
Address
Satellite no.502 in front of Kashiwanoha Campus, The University of Tokyo, 178-4-4 Wakashiba, Kashiwa City, Chiba Prefecture
Tel
04-7135-5609
office-bc@cspor-bc.or.jp
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
Completed
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
| 2024 | Year | 02 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024671
