UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randomized study of anthracycline vs. TS-1 in patients with metastatic or recurrent breast cancer
Title of the study (Brief title)	Selection of effective chemotherapy for breast cancer-CONFIRM(SELECT BC-CONFIRM)
Region	Japan

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

Objectives
Narrative objectives1	To test equivalency or non-inferiority of overall survival between anthracycline and TS-1 in patients with metastatic or recurrent breast cancer who receive first-line treatment with either an anthracycline or TS-1, followed by second-line treatment at their physician's discretion
Basic objectives2	Bio-equivalence
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase III

Assessment
Primary outcomes	Overall Survival
Key secondary outcomes	Progression-Free Survival Time To Treatment Failure Adverse Events Health-Related QOL Cost-effectiveness

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
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	Anthracycline group: One of the following anthracycline-based regimens is selected, and treatment is repeated until disease progression or for at least 6 courses. (1) AC (given at 3- or 4-week intervals) Doxorubicin: 40-60 mg/m2 Cyclophosphamide: 400-600 mg/m2 (2) EC (given at 3- or 4-week intervals) Epirubicin: 60-90 mg/m2 Cyclophosphamide: 400-600 mg/m2 (3) FAC (given at 3- or 4-week intervals) Fluorouracil: 500 mg/m2 Doxorubicin: 40-50 mg/m2 Cyclophosphamide: 500 mg/m2 (4)FEC (given at 3- or 4-week intervals) Fluorouracil: 500 mg/m2 Epirubicin: 60-100 mg/m2 Cyclophosphamide: 500 mg/m2
Interventions/Control_2	TS-1 group: TS-1 is given in a dose of 40-60 mg/m2 (adjusted to body surface area) twice daily (morning and evening) for 28 consecutive days followed by a 14-day rest.This 6-week period is regarded as one cycle. Treatment is repeated until disease progression or for 4 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	1) Histologically proven breast cancer 2) 1. Distant metastasis (Stage IV) at presentation or 2. Proven metastatic or recurrent breast cancer with distant metastasis 3) At least one assessable lesion 4) No prior chemotherapy 5) ECOG performance status 0-1 6) 1. No prior treatment with anthracyclines or taxanes or 2. At least 6 months have elapsed since last day of treatment with anthracyclines or taxanes 7) 1. No prior treatment with 5-FU or 2. At least 6 months have elapsed since last day of treatment with 5-FU 8) The anthracycline dose able to be administered per course of treatment is within the range described below. However, the lifetime total dose should not exceed the upper limit (doxorubicin 500 mg/m2, epirubicin 900 mg/m2),and the dose per course should be decided assuming that the scheduled 6 courses of protocol treatment will be administered with no reduction in dose. 1. doxorubicin:40-60 mg/m2 2. epirubicin:60-100 mg/m2 9) At least 7 days have elapsed since last day of hormonal therapy and at least 14 days since the completion of radiotherapy 10) 1. Estrogen receptor(-) and progesterone receptor(-) on tests of primary or recurrent lesions 2. First-line hormonal therapy ineffective after metastasis or recurrence, or 3. Metastasis or recurrence during postoperative adjuvant hormonal therapy or within 6 months after last day of hormonal therapy 5. CRE <=(every institution's reference value) (These values are examined within 21 days before registration for this study.)
Key exclusion criteria	1) HER2 (Her2/neu, Erb B2) IHC (3 +) or FISH (fluorescence in situ hybridization) (plus) for primary or metastatic lesion 2) Anaphylaxis against drugs or solvents used in protocol treatment 3) Active double cancers 4) Brain metastasis requiring treatment for increased intracranial pressure or requiring urgent irradiation 5) Extensive liver metastases or lymphatic lung metastases with dyspnea 6) Only one assessable lesion previously treated by radiotherapy 7) Retention of pleural fluid, ascitic fluid, or pericardial fluid requiring urgent treatment 8) Active infectious disease 9) Interstitial pneumonia or idiopathic interstitial pneumonia 10) HBs(+) 11) Diabetes mellitus that is poorly controlled or treated with insulin 12) Mental disease precluding participation in this study 13) Women who are pregnant, nursing infants,or plan to become pregnant
Target sample size	200

Research contact person
Name of lead principal investigator	Hirofumi Mukai
Organization	National Cancer Center Hospital East
Division name	Division of Oncology/Hematology
Address	6-5-1, Kasiwanoha, Kashiwa-shi, Chiba-ken, 227-8577, Japan
TEL	04-7133-1111
Email	hrmukai@east.ncc.go.jp

Public contact
Name of contact person	Akira Yamao
Organization	Public Health Research Foundation
Division name	Comprehensive Support Project for Clinical Research
Address	1-1-7, Nishiwaseda, Shinjuku-ku, Tokyo, 169-0051, Japan
TEL	03-5287-2633
Homepage URL	http://www.csp.or.jp/
Email	support@csp.or.jp

Sponsor
Institute	SELECT BC-CONFIRM executive committee
Institute
Department

Funding Source
Organization	Public Health Research Foundation
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2011 Year 04 Month 15 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2011 Year 03 Month 01 Day
Anticipated trial start date	2011 Year 04 Month 01 Day
Last follow-up date	2017 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2011 Year 04 Month 15 Day
Last modified on	2019 Year 01 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006465