Metastatic or recurrent breast cancer
Conditions
Interventions
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 inte
Sponsors
SELECT BC-CONFIRM executive committee
Eligibility
Sex/Gender
Female
Inclusion criteria
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.)
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free Survival Time To Treatment Failure Adverse Events Health-Related QOL Cost-effectiveness | — |
Countries
Japan
Contacts
Public ContactAkira Yamao
Public Health Research Foundation Comprehensive Support Project for Clinical Research
Outcome results
None listed