breast cancer
Conditions
Interventions
Group 1:fulvestrant
Group 2:fulvestrant combine with capecitabine
Sponsors
Department of Endocrine and Breast Surgery of the First Affiliated Hospital of Chongqing Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Volunteered for this study and informed consent was abtained from the participants. 2. Postmenopausal women need to meet one of the requirements below: (1) Removed bilateral ovariam; (2) Aged 60 years old and more; (3) Aged<60 years old but amenorrhea=12 months when havent conducted chemotherapy or endocrine therapy, besides FSH and estrogen are range between the postmenopausal hormonal levels; (4) FSH and estrogen must to be range between the postmenopausal hormonal levels when patients age<60 years old and taking tamoxifen or toremifene therapy; 3. Diagnosis as breast cancer according to clinical practice guideline; 4. Identify the estrogen receptor positive(ER+) according to the laboratory examination of primary lesions or metastatic lesions; 5. It needs to meet one of the requirements below when conduct endocrine therapy: (1) Tumor recurrence in 12 months after adjuvant endocrine therapy; (2) Conduct endocrine therapy at least 12 months after finished adjuvant endocrine therapy; (3) The progressive breast cancer patients who have treatment failure when take endocrine therapy as fist line therapy. 6. Conform to one of the standards below: (1) Exist measurable quantity lesions according to RECIST 1.1 standard; (2) Not exist measurable quantity lesions according to RECIST 1.1 standard, but exist osteolytic or mixed bone metastasis; 7. WHO performance status score of 01 or 2.
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 malignant tumor in the past three years (excluding breast cancer and adequate therapeutic skin basal cell carcinoma or scale carcinoma or carcinoma in situ of cervix); 8. 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); 9. Medical history: (1) Bleeding habitus (such as DIC or lack of blood coagulation factors); (2) Long-term anticoagulant therapy; 10. Allergic to active or inactive fulvestrant vehicle and/or castor oil; 11. Coexistence of other serious medical conditions, such as serious infections, organs failure, serious injury, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival(PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective remission rate;Clinical benefit rate;Duration of remission;Duration of clinical benefit;The frequency and severity of adverse events ; | — |
Countries
China
Contacts
Public ContactRen Guosheng; Li Hongyuan
Department of Endocrine and Breast Surgery of the First Affiliated Hospital of Chongqing Medical University
Outcome results
None listed