Metastatic or recurrent breast cancer
Conditions
Interventions
Taxane arm is given one administration chosen from below three pattern of administration by doctor. We repeat it 6 cycles or till cancer becomes worse. (1) Dosetaxel 60-75mg/m2 (one cycle: 3 or 4 we
Sponsors
SELECT BC executive committee
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1)Histologically proven breast cancer 2)(a)Distant metastasis (Stage IV) in first diagnosis or (b) Proven metastatic or recurrent breast cancer after treatment by distant metastasis 3)At least one assessable lesion 4)No prior chemotherapy 5)ECOG performance status 0-1 6)(a)No prior Taxane administration or (b)Having passed at least 6 months since last Taxane administration 7)(a)No prior 5-FU administration or (b)Having passed more than 6 months since last 5-FU administration 8)Having passed more than 7 days since last hormonal therapy and more than 14 days since last radiation therapy 9)(a)Estrogen receptor(-) and progesterone receptor(-) in test of primary or recurrent lesion, (b) Ineffective primary hormonal therapy after metastasis or recurrence or (c)Metastasis or recurrence during postoperative adjuvant hormone therapy or within 6 months after last hormone therapy 10)Neutrophilic leukocyte>=1,500 or WBC>=3,000, PLT>=100,000, T-B<=(every institution's reference value)*2.5, AST(GOT)<=(every institution's reference value)*2.5, CRE<=(every institution's reference value) (these values are examined within 21 days before registration for this study) 11)No cardiac disease or no limitation of physical activity due to cardiac disease 12)Written informed consent
Exclusion criteria
Exclusion criteria: 1)During pregnancy or lactation, or planning to get pregnant 2)HER2(Her2/neu, Erb B2) IHC (3+) or FISH(fluorescence in situ hybridization) (+) at primary or metastatic lesion 3)Anaphylaxis against medicine or solvent of this protocol treatment 4)Active double cancers 5)Brain metastasis which needs treatment for hyperfunction of intracranial pressure or urgent irradiation 6)Extended liver metastasis or lymphatic lung metastasis with dyspnea 7)Only one assessable lesion having past radiation therapy 8)Retention of pleural fluid, ascites and pericardial fluid which need urgent treatment 9)Active infectious disease 10)Interstitial pneumonia or idiopathic interstitial pneumonia 11)HBs(+) 12)Diabetes mellitus in bad control or during insulin treatment 13)Mental disease with difficulty of taking part in this study 14)Patients judged inappropriate for this study by the physicians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free Survival Time To Treatment Failure Adverse Events Hearth-Related QOL Efficacy of medical economy | — |
Countries
Japan
Contacts
Public ContactShizuhiro Yamada
Public Health research Foundation Comprehensive Support Project for Clinical Research
Outcome results
None listed