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.

Closed
Phase
III
Accrual
100%
Published
Abbreviated Title
ADVANCED: Anastrozole vs. Anastrozole and Fulvestrant
Status Notes
All patient Follow-up is ending on 10/1/2018.
Activated
04/01/2004
Closed
07/01/2009
Participants
NCORP, Members, Medical Oncologists, Surgeons, CTSU, Affiliates

Research committees

Breast Cancer

Treatment

Surgery Anastrozole Fulvestrant

Eligibility Criteria Expand/Collapse

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).

Publication Information Expand/Collapse

2018

Survival by Hispanic Ethnicity among Cancer Patients Participating in SWOG Clinical Trials

M Chavez-MacGregor;J Unger;A Moseley;S Ramsey;DL Hershman Cancer Apr 15;124(8):1760-1769; Jan 25 [Epub ahead of print]

PMid: PMID29370458 | PMC number: PMC5963502

Association of Cardiovascular Risk Factors With Cardiac Events and Survival Outcomes Among Patients With Breast Cancer Enrolled in SWOG Clinical Trials

D Hershman;C Till;S Shen;J Wright;S Ramsey;W Barlow;J Unger Journal of Clinical Oncology Mar 27 [Epub ahead of print]

PMid: PMID29584550 | PMC number: PMC Journal - In Process

The association between ASCO Value framework and scientific and clinical impact of SWOG phase III clinical trials

V Nghiem;R Vaidya;M Banegas;D Hershman;J Unger AcademyHealth Annual Research Meeting (June 23-26, 2018, Seattle, WA), poster

Survival by Hispanic Ethnicity Among Cancer Patients participating in SWOG Clinical Trials

A Moseley;M Chavez-MacGregor;J Unger;S Ramsey;D Hershman Society for Clinical Trials Annual Meeting (May 20-23 2018, Portland, OR), oral presentation

2017

The effect of positive SWOG treatment trials on survival of patients with cancer in the US population

JM Unger;M Leblanc;CD Blanke JAMA Oncology Oct 1;3(10):1345-1351

PMid: PMID28586789; PMC5710507

The impact of positive SWOG treatment trials on population survival

J Unger;M LeBlanc;C Blanke J Clin Oncol 35, 2017 (suppl; abstr 6513); American Society of Clinical Oncology Annual Meeting (June 2-6, 2017, Chicago, IL), poster discussion

A phase III randomized trial of anastrozole and fulvestrant versus anastrozole or sequential anastrozole and fulvestrant as first-line therapy for postmenopausal women with metastatic breast cancer: Final survival outcomes of SWOG S0226 [https://www.abstracts2view.com/sabcs17/view.php?nu=SABCS17L_258]

R Mehta;W Barlow;K Albain;T Vandenberg;S Dakhil;N Tirumali;D Lew;D Hayes;J Gralow;H Linden;R Livingston;G Hortobagyi San Antonio Breast Cancer Symposium (December 5-9, 2017, San Antonio, TX), poster discussion

Association Between Cardiovascular Risk Factors and Cardiac Events Among Breast Cancer Patients Enrolled in SWOG Clinical Trials

D Hershman;C Till;J Wright;S Ramsey;W Barlow;JM Unger San Antonio Breast Cancer Symposium (December 5-9, 2017, San Antonio, TX), poster

2016

Fulvestrant decreases anastrozole drug concentrations when taken concurrently by patients with metastatic breast cancer treated on SWOG study S0226

D Hertz;W Barlow;K Kidwell;K Albain;T Vandenberg;S Dakhil;N Tirumali;R Livingston;J Gralow;D Hayes;G Hortobagyi;R Mehta;J Rae British Journal of Clinical Pharmacology Jun;81(6):1134-1141; 2016 Feb 9 [Epub ahead of print]

PMid: PMID26859101 | PMC number: PMC4876171

2015

Association between gene variants in SULT1A1 and UGT1A4 and disease outcomes in patients enrolled in SWOG S0226 and treated with anastrozole alone or in combination with fulvestrant for metastatic breast cancer

S Kadlubar;W Barlow;R Mehta;J Daniels;K Albain;T Vandenberg;S Dakhil;N Tirumali;D Lew;J Gralow;R Livingston;G Hortobagyi;D Hayes;JM Rae San Antonio Breast Cancer Symposium (December 8-12, 2015, San Antonio, TX), poster, abst.# P3-07-64;

2012

Combination anastrozole and fulvestrant in metastatic breast cancer: SWOG S0226

R Mehta;W Barlow;K Albain;T Vandenberg;S Dakhil;N Tirumali;DL Lew;DF Hayes;JR Gralow;R Livingston;GN Hortobagyi New England Journal of Medicine 367(5):435-444;

PMid: PMID22853014 | PMC number: PMC3951300

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;

Other Clinical Trials

SWOG Clinical Trial Number
SWOG-7436

Combined Modality Therapy of Breast Carcinoma Phase III

Research Committee(s)
Breast Cancer
Activated
01/09/1975
Closed
07/18/1979
Accrual
100%
Closed
Phase
III
Published
SWOG Clinical Trial Number
SWOG-7827

Combined Modality Therapy For Breast Carcinoma Phase III

Research Committee(s)
Breast Cancer
Activated
07/16/1979
Closed
08/01/1989
Accrual
100%
Closed
Phase
III
Published