None listed
Conditions
Interventions
Drug : Arm I: Patients receive fulvestrant 500 mg IM (1st cycle, loading
500mg IM on D1, 15, then every 4 weeks, 2nd cycle is going to be received on D29) with goserelin 3.6 mg SC in every 4 weeks till documentation of disease progression.
Arm II: Patients receive anastroz
Sponsors
Samsung Medical Center
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) All patients must be female and premenopausal. Premenopausal is defined as either: ? last menstrual period within 3 months, or ? post-hysterectomy without bilateral oophorectomy and with FSH in the premenopausal range (= 30 mIU/mL), or, ? if on tamoxifen within the past 3 months, a plasma estradiol in the premenopausal range (=20 pg/mL), ? if in case of chemotherapy induced amenorrhea, a plasma estradiol in the premenopausal range (=20 pg/mL). 2) Patients must have either positive estrogen and/or progesterone receptor determination by IHC or competitive binding assay on metastatic disease, or if not performed on their metastatic disease a positive result on their primary breast cancer specimen (Positivity is defined as an Allred score from 3 to 8 by IHC or at least 1% positive tumor nuclei in the sample in the presence of expected reactivity of internal and external controls [36]). 3) No HER2 overexpressing breast cancer by IHC 3+ or FISH. 4) Patients who recurred after 5 years of tamoxifen use or would not be considered for resume to tamoxifen treatment as physician/s discretion or if patients who could not use tamoxifen for 5 years, the duration of tamoxifen treatment should be at least 12 weeks or more. 5) Patients who showed progressive disease on tamoxifen treatment as a palliative hormonal therapy or an adjuvant endocrine treatment 6) No prior treatment with an aromatase inhibitor or inactivator or fulvestrant. 7) Prior treatment with an LH/RH agonist for adjuvant and/or palliative treatment are allowed if the last treatment has finished before 1 year of study entry. 8) No adjuvant chemotherapy within 1 year of study entry. 9) The patients who progressed after achieving response or disease control to previous 1st line chemotherapy for metastatic disease are allowed. 10) Patients must have an ECOG performance status of 0, 1, or 2. 11) Adequate organ function as determined by the following laboratory results, within approximately 14 days prior to randomization: ? Absolute neutrophil count = 1500 cells/?, ? Platelet count = 100,000 cells/?, ? Hemoglobin = 9.0 g/dL; patients may receive red blood cell transfusions to obtain this level, ? Total bilirubin = 1.5 ?upper limit of normal (ULN) unless the patient has documented Gilbert’s syndrome, ? SGOT (AST), SGPT (ALT), and alkaline phosphatase (ALP) = 2.5 ? ULN, or ALP, AST and ALT = 5.0?ULN if judged by the investigator to be related to liver metastases. ? International normalized ratio (INR) and activated partial thromboplastin time (aPTT) < 1.5 ?ULN (unless on therapeutic anti-coagulation). 12) Patients must not have received tamoxifen therapy for at least 2 weeks prior to enrollment. 13) Concomitant irradiation to any bony sites of disease for pain control or for prevention of fracture is allowed at the time of randomization. Radiation therapy for documented disease progression is not allowed. 14) Bisphosphonates for the treatment of bone metastases should not be initiated following the first dose of randomized therapy. It must be initiated prior to day of treatment (cycle 1, day 1). Patients may continue on bisphosphonates who already established on bisphophonate therapy for bone metastases. 15) Patients who are pregnant or lactating are ineligible. A negative pregnancy test must be available for all subject of the study. 16) For women of childbearing potential and men with partners of childbearing potential, agreement to use one highly effective form o
Exclusion criteria
Exclusion criteria: 1) No prior treatment with an LH/RH agonist/antagonist within 1 year ofstudy entry for adjuvant or palliative endocrine therapy. 2) Patients must not have received more than 1 prior chemotherapy regimen for metastatic disease. 3) Lymphangitic pulmonary metastases 4) Symptomatic hepatic metastases 5) Documented parenchymal or leptomeningeal brain metastasis 6) HER-2 overexpressing breast cancer and concomitant trastuzumab treatment is not allowed 7) Serious uncontrolled intercurrent infections 8) Serious intercurrent medical or psychiatric illness, including active cardiac disease 9) Pregnancy or breast feeding 10) Second primary malignancy (except in situ carcinoma of the cervix or resected papillary thyroid carcinoma or adequately treated nonmelanomatous carcinoma of the skin or other malignancy treated at least 5 years previously with no evidence of recurrence)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time To Progression(TTP) | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall response rate as measured by RECIST 1.1;Overall survival;Qualitative and quantitative toxicity as assessed by NCI CTCAE v3.0;Biochemical response - estradiol (E2), LH, and FSH levels | — |
Countries
Korea, Republic of
Contacts
Public ContactSeona Jang
Samsung Medical Center
Outcome results
None listed