Hormone receptor positive, HER2 negative advanced or recurrence (metastatic) breast cancer
Conditions
Interventions
weekly paclitaxel + bevacizumab
endocrine therapy + bevacizumab then back to weekly paclitaxel + bevacizumab therapy
Sponsors
Japan Breast Cancer Research Group (JBCRG)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed adenocarcinoma of the breast 2. Female aged 20-75 years old at getting informed consent 3. HER2 negative disease (IHC 0/1+ or 2+ with FISH negative) 4. Documented estrogen receptor (ER) positive (>=1% by IHC) 5. Inoperative locally advanced or metastatic breast cancer at enrolment 6. Performance status (ECOG): 0-1 at enrolment 7. Life expectancy of at least 3 months from enrolment 8. No prior systemic therapy for recurrent breast cancer (excluding hormone therapy) 9. No prior neo and/or adjuvant chemotherapy with taxane or adjuvant setting with a disease-free interval from completion of the taxane treatment to metastatic diagnosis of >= 12 months 10. Patients with measurable lesion regarding with RECIST criteria or who have evaluable lesion 11. Patients with only bone lesion will be acceptable if the osteolytic lesion has a measurable soft tissue component by MRI or CT 12. No influence on protocol treatment is considered in case prior therapy or examination. 13. Adequate following organ function within 2 weeks before starting treatment. The latest examination results should be adopted and blood transfusion or treatment of hematopoietic factor drugs is not allowed 2 weeks before examination. - Absolute neutrophil count >= 1500 /mm3 or WBC count >= 3000 /mm3 - Platelets >=10 x 10000 /mm3 - Hb >= 9 g/dL - Total bilirubin <= 1.5 mg/dL(except for constitutional jaundice) - AST and ALT <= 100IU/L (<=200IU/L if liver metastasis) - Serum creatinine <= 1.5 mg/dL -Urine dipstick for proteinuria <= 1+ 14. Written informed consent signed by patients before completing any treatment related procedure
Exclusion criteria
Exclusion criteria: (1)Prior therapy with bevacizumab (2) Active infection requiring intrvenous antibiotics at enrollment or infection with active HBV and/or HCV. (3) Pregnancy, lactetion or in case of potentialy pregnancy women Not mind contraception in trial period. (4) Known hypersensitivity to bevacizumab or paclitaxel (5) History of hemoptysis (>= 2.5mL of bright red blood per episord). (6) Use of disulfiram,cyanamide, carmofur or procarbazine Hydrochloride (7) Patients with CNS metastases (except for not symptomatic) (8) Persistent Grade >= 2 sensory neuropathy at enrollment (9) Grade 3 >= hypertension (>= 2 use of antihypertensive drug) 10) Evidence with arterial thromboembolism (Cerebral infarction, Myocardial infarction) or history within 1 year prior to enrollment. (11) Evidence withvenous thromboembolism (deep vein thrombosis, pulmonary embolism) or history within 1 year prior to enrollment. (12) History of GI perforation and/or serious abdominal fistula within 1 year prior to enrollment (13) Cases that the investigator judged as inappropriate as the subject of this clinical study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to failure of strategy (TFS) | — |
Secondary
| Measure | Time frame |
|---|---|
| 2y Overall Survival rate, Overall Survival, Progression Free Survival: PFS, QOL, Biomarker, Safety | — |
Countries
Japan
Contacts
Public ContactJun Fukase
Japan Breast Cancer Research Group (JBCRG) Head office
Outcome results
None listed