breast cancer
Conditions
Interventions
B:exemestane with metronomic capecitabine
Sponsors
Department of Oncology, East District of Suzhou Municipal Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Adult women ( Aged>18 yearse) with proven diagnosis of adenocarcinoma of the breast with evidence of locoregionally recurrent or metastatic disease not amenable to resection or radiation therapy with curative intent and for whom there was either visceral crisis or rapidly progressive diseases; 2. Documentation of histologically or cytologically confirmed diagnosis of estrogen-receptor positive breast cancer based on laboratory results; 3. Postmenopausal status and premenopausal status with ovarian suppression drug; 4. The progressive breast cancer patients who have treatment failure when take endocrine therapy ; 5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2; 6. Life expectancy more than 3 months; 7. Adequate organ and bone marrow function defined as follows: (1) Absolute Neutrophil Count (ANC)=1,500/mm3 (1.5x10^9/L); (2) Platelets=100,000/mm3(100x10^9/L); (3) Hemoglobin=9g/dL(90g/L); (4) Serum creatinine =1.5xUpper Limit of Normal(ULN) or estimated creatinine clearance=60 mL/min as calculated using the method standard for the institution; (5) Total serum bilirubin =1.5xULN (=3.0xULN if Gilberts disease); (6) AST and/or ALT=3xULN (=5.0xULN if liver metastases present); 8. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures; 9. Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.
Exclusion criteria
Exclusion criteria: 1. Those who take part in the study planning or study execution; 2. Coexistence of life-threatening metastasis internal organs diseases; 3. Those who have taken more than one chemotherapy regimens which aim at metastasis breast cancer; 4. Those who have taken more than one endocrine therapy regimens which aim at progressive breast cancer; 5. Received extensive radiotherapy in the past four weeks, or conducted cytotoxic agent therapy in four weeks before laboratory examinations, or received Sr or other radiotherapy in the past three months; 6. Received unapproved or testing drugs therapy in four weeks before randomization; 7.Existence of any of the following laboratory examination results: (1) Blood platelet count1.5×ULRR; (3) ALT or AST>2.5×ULRR when without hepatic metastases; ALT or AST>5×ULRR when with hepatic metastases; (4) Serious impairment of renal function (creatinine clearance(CCR)<30ml/min); 8. Medical history: (1) Bleeding habitus (such as DIC or lack of blood coagulation factors); (2) Long-term anticoagulant therapy; 9. Coexistence of other serious medical conditions, such as serious infections, organs failure, serious injury, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective remission rate;Clinical benefit rate;The frequency and severity of adverse events; | — |
Countries
China
Contacts
Public ContactJun Qian
Department of Oncology, East District of Suzhou Municipal Hospital
Outcome results
None listed