SWOG clinical trial number
S0226
Phase III Randomized Trial of Anastrozole Versus Anastrozole and Fulvestrant as First Line Therapy for Post Menopausal Women With Metastatic Breast Cancer.
Abbreviated Title
ADVANCED: Anastrozole vs. Anastrozole and Fulvestrant
Status Notes
S0226 was completed on 10/1/2018. All patient follow-up has ended and the IND for this study was closed. Any remaining drug must be destroyed per institutional procedures and drug accountability records maintained per 21 CFR 312.62 and institutional procedures.
Treatment
Surgery
Anastrozole
Fulvestrant
Female; pathologically confirmed diagnosis of metastatic breast cancer (M1) or multiple sites of new disease that is clinically obvious metastatic disease; post-menopausal as defined by prior bilateral oophorectomy, >12 months since LMP w/ no prior hysterectomy, > or = 55 yrs of age w/ no prior hysterectomy, < 55 yrs of age w/ prior hysterectomy w/o oopherectomy (estradiol and FSH must be consistent w/ post-menopausal;ER or PGR positive (or both), estrogen binding of 10 fmol/mg cytosol protein by ligand binding assay or IHC; must have measurable or non-measureable disease; no history of prior chemotherapy, hormone therapy, or immunotherapy for recurrent or metastatic disease (prior adjuvant or neoadjuvant chemotherapy if completed > 12 months prior to randomization is acceptable); any number of prior hormonal therapy regimens for the adjuvant setting but not for metastatic disease or recurrent disease is allowed; prior adjuvant or neoadjuvant treatment with an aromatase inhibitor (e.g. anastrozole, letrozole, exemestane) or fulvestrant will be allowed, if completed more than 12 months prior to randomization; patients w/ prior adjuvant therapy using LHRH analogue are eligible provided that therapy has discontinued 12 months prior to randomization and patient has not resumed their menstrual periods; INR < or = 1.6 w/in 28 days prior to registration; w/o bleeding diathesis or no prior history of long-term anti-coagulant therapy; no brain or CNS metastases; PS=0-2; must be HIV negative; no other prior malignancy except: basal cell or squamous cell skin cancer, in situ cervical cancer, Stage I or II cancer (from which patient is in complete remission), or any other cancer (patient must be disease-free for at least 5 yrs).
2011
A phase III randomized trial of anastrozole versus anastrozole and fulvestrant as first-line therapy for postmenopausal women with metastatic breast cancer: SWOG S0226
R Mehta;W Barlow;K Albain;T Vandenberg;S Dakhil;N Tirumali;D Lew;D Hayes;J Gralow;R Livingston;G Hortobagyi San Antonio Breast Cancer Symposium 2011 Meeting, abst. S1-1;oral presentation;
