UMIN-CTR Clinical Trial

Public title

Randomized study of anthracycline vs. TS-1 in patients with metastatic or recurrent breast cancer

Acronym

Selection of effective chemotherapy for breast cancer-CONFIRM(SELECT BC-CONFIRM)

Scientific Title

Randomized study of anthracycline vs. TS-1 in patients with metastatic or recurrent breast cancer

Scientific Title:Acronym

Selection of effective chemotherapy for breast cancer-CONFIRM(SELECT BC-CONFIRM)

Region

Japan

Condition

Metastatic or recurrent breast cancer

Classification by specialty

Hematology and clinical oncology

Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO

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

Primary outcomes

Overall Survival

Key secondary outcomes

Progression-Free Survival
Time To Treatment Failure
Adverse Events
Health-Related QOL
Cost-effectiveness

Study type

Interventional

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

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Hirofumi Mukai

Organization

National Cancer Center Hospital East

Division name

Division of Oncology/Hematology

Zip code

Address

6-5-1, Kasiwanoha, Kashiwa-shi, Chiba-ken, 227-8577, Japan

TEL

04-7133-1111

Email

hrmukai@east.ncc.go.jp

Name of contact person

1st name
Middle name
Last name	Akira Yamao

Organization

Public Health Research Foundation

Division name

Comprehensive Support Project for Clinical Research

Zip code

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

Institute

SELECT BC-CONFIRM executive committee

Institute

Department

Personal name

Organization

Public Health Research Foundation

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2011

Year

04

Month

15

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Main results already published

Date of protocol fixation

2011

Year

03

Month

01

Day

Date of IRB

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

Other related information

Registered date

2011

Year

04

Month

15

Day

Last modified on

2019

Year

01

Month

09

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006465