CSPOR

SELECT BC-CONFIRM

A Randomized Study Comparing Anthracycline-based regimens with TS-1 in Patients with Metastatic or Recurrent Breast Cancer

Study design

This is a multicenter, collaborative, open-label, randomized, parallel-group, controlled study.

Trial Schema

Trial schema

Anthracycline group

One of the following regimens will be selected at the discretion of the attending physician, and treatment will be repeated until disease progression or for at least 6 courses. However, the same anthracycline derivative as that used before surgery will be used after surgery.

If a regimen including doxorubicin is used for preoperative/postoperative treatment,
Protocol treatment: A regimen including doxorubicin will be selected.
If a regimen including epirubicin is used for preoperative/postoperative treatment,
Protocol treatment: A regimen including epirubicin will be selected.

For second-line treatment, chemotherapy will be selected from among the regimens specified in the study protocol. Third-line or subsequent treatment is not specified. The total administered dose of anthracycline derivatives should not exceed 500 mg/m2 of doxorubicin or 900 mg/m2 of epirubicin as a general guideline. Cardiac function should be evaluated by cardiac ultrasonography as required.

AC (given at 3- or 4-week intervals)
Doxorubicin 40 to 60 mg/m2
Cyclophosphamide 400 to 600 mg/m2
EC (given at 3- or 4-week intervals)
Epirubicin 60 to 90 mg/m2
Cyclophosphamide 400 to 600 mg/m2
FAC (given at 3- or 4-week intervals)
Fluorouracil 500 mg/m2
Doxorubicin 40 to 50 mg/m2
Cyclophosphamide 500 mg/m2
FEC (given at 3- or 4-week intervals)
Fluorouracil 500 mg/m2
Doxorubicin 60 to 100 mg/m2
Cyclophosphamide 500 mg/m2

Objectives

To verify that overall survival in the TS-1 group is at least equivalent (non-inferior) to that in the anthracycline group in women with metastatic or recurrent breast cancer who receive an anthracycline derivative or TS-1 as first-line therapy, as compared with the results of the SELECT BC study.
Adverse events, HRQOL, and medical economic evaluation will be compared between the treatment groups.

Primary endpoint: Overall survival (OS)

Secondary endpoints: Progression-free survival (PFS), time to treatment failure (TTF), adverse events, HRQOL, and medical economic evaluation

Scheduled number of patients and study period

Planned sample size: A total of 200 patients (100 per group).
Enrollment period: 2.5 years from the registration of the 1st patient.
Follow-up: 4.5 years (after enrollment of the last patient).

Clinical trial registration

Registered trial number: UMIN 000005449

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