S1222 Trial (Everolimus, Anastrozole and Fulvestrant) in Post-Menopausal Stage IV Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
AstraZeneca
Novartis
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT02137837
First received: May 12, 2014
Last updated: May 20, 2015
Last verified: May 2015
  Purpose

This randomized Phase III trial studies how well the combination of fulvestrant and everolimus together or the combination of anastrozole, fulvestrant and everolimus together, improve progression-free survival (PFS) versus fulvestrant alone.


Condition Intervention Phase
Breast Cancer
Drug: Fulvestrant
Drug: Anastrozole
Drug: Everolimus
Drug: Placebo - Anastrozole
Drug: Placebo - Everolimus
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Fulvestrant Alone Versus Fulvestrant and Everolimus Versus Fulvestrant, Everolimus and Anastrozole: A Phase III Randomized Placebo-Controlled Trial in Postmenopausal Patients

Resource links provided by NLM:


Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • progression-free survival [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • overall survival [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
  • Number of Participants with Serious and Non-Serious Adverse Events [ Time Frame: up to 5 years ] [ Designated as safety issue: Yes ]
  • response rate [ Time Frame: assessed every 12 weeks, up to 5 years ] [ Designated as safety issue: No ]
  • clinical benefit rate [ Time Frame: assessed every 12 weeks, up to 5 years ] [ Designated as safety issue: No ]
  • molecular determinants of response in circulating tumor cells [ Time Frame: Day 1, Day 29, time of progression ] [ Designated as safety issue: No ]

Estimated Enrollment: 825
Study Start Date: May 2014
Estimated Study Completion Date: May 2018
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Arm 1: fulvestrant + everolimus placebo + anastrozole placebo
Patients receive an injection of fulvestrant in each buttock on Days 1 &15 for Cycle 1 and then Day 1 only for subsequent cycles. Patients also receive an oral placebo daily for both everolimus and anastrozole. This treatment regimen will continue until disease progression or toxicity.
Drug: Fulvestrant
Other Names:
  • Faslodex
  • NSC-719276
Drug: Placebo - Anastrozole Drug: Placebo - Everolimus
Experimental: Arm 2: fulvestrant + everolimus + anastrozole placebo
Patients receive an injection of fulvestrant in each buttock on Days 1 &15 for Cycle 1 and then Day 1 only for subsequent cycles. Patients also receive an oral everolimus and an oral placebo for anastrozole daily. This treatment regimen will continue until disease progression or toxicity.
Drug: Fulvestrant
Other Names:
  • Faslodex
  • NSC-719276
Drug: Everolimus
Other Names:
  • Afinitor
  • Zortress
  • NSC-733504
Drug: Placebo - Anastrozole
Experimental: Arm 3: fulvestrant + everolimus + anastrozole
Patients receive an injection of fulvestrant in each buttock on Days 1 &15 for Cycle 1 and then Day 1 only for subsequent cycles. Patients also receive everolimus and anastrozole by mouth daily. This treatment regimen will continue until disease progression or toxicity.
Drug: Fulvestrant
Other Names:
  • Faslodex
  • NSC-719276
Drug: Anastrozole
Other Names:
  • Arimidex
  • NSC-719344
Drug: Everolimus
Other Names:
  • Afinitor
  • Zortress
  • NSC-733504

Detailed Description:

OBJECTIVES:

Primary

  • To test the benefit of interfering with the function of the estrogen receptor (ER) and providing downstream target inhibition (PI3K/AKT/mTOR) with a combination of optimal dose fulvestrant and everolimus (Arm 2) to improve progression-free survival compared to the optimal dose fulvestrant alone (Arm 1).
  • To test the benefit of adding the non-steroidal aromatase inhibitor anastrozole to optimal dose fulvestrant and everolimus (Arm 3) in order to improve progression free survival over optimal dose fulvestrant (Arm 1).

Secondary

  • To compare progression-free survival among those receiving fulvestrant + everolimus + anastrozole (Arm 3) versus fulvestrant + everolimus (Arm 2).
  • To compare overall survival among the treatment arms in post-menopausal patients with hormone-receptor positive (HR+) Stage IV breast cancer.
  • To assess and compare toxicities, feasibility and compliance among the study regimens.
  • To compare response rates and clinical benefit rates among the study regimens.
  • To test molecular determinants of response to endocrine therapy and everolimus in circulating tumor cells:

    1. CTC-Endocrine Therapy Index (CTC ETI) on the CellSearch® platform.
    2. CTC-Next Generation Sequencing Analysis (CTC-NGS) of single cells captured on the HD-CTC® platform.

OUTLINE:

This is a multicenter study. Patients will be stratified according to the following factors:

  • Measurable versus evaluable non-measurable disease
  • Prior adjuvant hormonal therapy completed more than 5 years ago vs. prior adjuvant hormonal therapy completed 1-5 years ago vs. de novo presentation of metastatic disease or no prior adjuvant hormonal therapy.

ARMS:

  • Arm 1: fulvestrant + placebo (everolimus) + placebo (anastrozole)
  • Arm 2: fulvestrant + everolimus + placebo (anastrozole)
  • Arm 3: fulvestrant + everolimus + anastrozole

Blood and tissue samples are collected for correlative science studies.

After completion of study treatment, patients are followed up every 6 months for 2 years and then yearly thereafter for 5 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria
  • Patients must have a histologically confirmed diagnosis of invasive breast carcinoma with positive estrogen and/or progesterone receptor status, and negative human epidermal growth factor receptor (HER-2), for whom endocrine therapy is planned.
  • The HER-2 test result is negative (and should be reported as such), if a single test (or all tests)performed in a tumor specimen show:

    • Immunohistochemistries (IHC) 1+ negative or IHC 0 negative or
    • in situ hybridization (ISH) negative using a single probe ISH or dual probe ISH.
  • Estrogen receptor (ER) and progesterone receptor (PgR) positivity must be assessed according to American Society of Clinial Oncology (ASCO)/College of American Physicians (CAP) guidelines as either ER or PR ≥ 1% positive nuclear staining. If HER2 IHC is 2+, an evaluation for gene amplification must be performed and the gene must not be amplified. Gene amplification evaluation is not required if evaluation by IHC is 0 or 1+ by institutional standards.
  • Patients must be post-menopausal women with a confirmed diagnosis of metastatic breast cancer (M1). Pathologic confirmation of histology is preferable. In the case of bone metastases only, biopsy-proven metastatic disease of solitary site, or multiple sites of involvement are required. Post-menopausal is defined by one of the following criteria as per National Comprehensive Cancer Network (NCCN) guidelines Version 3. 2013:

    • Prior bilateral oophorectomy and/or hysterectomy
    • Patients ≥ 60 years of age
    • Patients < 60 years of age and amenorrheic for ≥ 12 months in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression and follicle-stimulating hormone (FSH) and estradiol in the post-menopausal range
    • Patients < 60 years of age taking tamoxifen or toremifene must have FSH and plasma estradiol levels within post-menopausal ranges
  • Patients must have measurable or evaluable disease. Patients must have a chest and abdominal computerized tomography (CT) and bone scan within 28 days prior to registration. All scans needed for assessment of measurable disease must be performed within 28 days prior to registration. Evaluable disease must be assessed within 28 days prior to registration
  • Patients with a history of prior chemotherapy or hormone therapy or immunotherapy for recurrent or metastatic disease are NOT eligible. Prior adjuvant or neoadjuvant chemotherapy if completed more than 12 months prior to registration is acceptable. Any number of prior hormonal therapy regimens for the adjuvant setting but not for metastatic or recurrent disease is allowed; prior adjuvant or neoadjuvant treatment with an aromatase inhibitor (e.g. anastrozole, letrozole, exemestane) is allowed, if completed more than 12 months prior to randomization.
  • Patients who have taken luteinizing hormone-releasing hormone (LHRH) analogue as adjuvant therapy are eligible provided they have a) discontinued such therapy at least 12 months prior to registration AND b) have not resumed their menstrual periods.
  • Patients must not have had prior exposure to fulvestrant or mTOR inhibitors (e.g., rapamycin, everolimus, temsirolimus, deforolimus). Concurrent bisphosphonate therapy is allowed. Patients must not have prior treatment with any investigational drug within 28 days prior to registration and must not be planning to receive any other investigational drug for the duration of the study.
  • Patients must have an International Normalized Ratio (INR) ≤ 1.6 within 28 days prior to registration.
  • Patients must have adequate bone marrow function, as defined by Absolute Neutrophil Count (ANC) of ≥ 1,500/mL, hemoglobin ≥ 9 g/dL and a peripheral platelet count ≥ 100,000/ mL, all within 28 days prior to registration.
  • Patients must have adequate hepatic function obtained within 28 days prior to registration and documented by all of the following:

    • Bilirubin ≤ 1.5 mg/dL (or ≤ 3.0 mg/dL if due to Gilbert's Syndrome)
    • alanine aminotransferase (ALT) (SGPT) and aspartate aminotransferase (AST) (SGOT) ≤ 2.5 x Institutional Upper Limit of Normal (IULN), or ≤ 5 x IULN if hepatic metastases are present.
  • Patients must have adequate renal function with serum creatinine level ≤ IULN within 28 days prior to registration.
  • Patients must have a fasting cholesterol ≤ 300 mg/dL and triglycerides ≤ 2.5 x IULN obtained within 28 days prior to registration. Patients may be on lipid lowering agents to reach these values.
  • Patients must have a complete history and physical examination within 28 days prior to registration.
  • Patients with bleeding diathesis (i.e., disseminated intravascular coagulation [DIC], clotting factor deficiency) or long-term anti-coagulant therapy (other than antiplatelet therapy) are NOT eligible.
  • Patients with presence of life-threatening metastatic visceral disease, defined as extensive hepatic involvement, or any degree of brain or leptomeningeal involvement (past or present), or symptomatic pulmonary lymphangitic spread are not eligible. Patients with discrete pulmonary parenchymal metastases are eligible, provided their respiratory function is not significantly compromised as a result of disease in the opinion of the investigator.
  • Patients must have a performance status of 0 - 2 by Zubrod criteria.
  • Patients must not have any Grade III/IV cardiac disease as defined by the New York Heart Association Criteria (i.e., patients with cardiac disease resulting in marked limitation of physical activity or resulting in inability to carry on any physical activity without discomfort), unstable angina pectoris, myocardial infarction within 6 months, or serious uncontrolled cardiac arrhythmia.
  • Patients must not have uncontrolled diabetes (defined as an Hg A1C >7% within 28 days prior to registration).
  • Patients must not have an organ allograft or other history of immune compromise. Patients must not be receiving chronic, systemic treatment with corticosteroids or other immunosuppressive agent. Topical or inhaled corticosteroids are allowed.
  • Patients known to be HIV positive may be enrolled if baseline CD4 count is > 500 cells/mm3 AND not taking anti-retroviral therapy. Patients with known chronic or active hepatitis are not eligible. Patients must not have any known uncontrolled underlying pulmonary disease.
  • Patients must be able to take oral medications. Patient may not have any impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of everolimus (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection).
  • Patients must not have received immunization with an attenuated live vaccine (e.g. intranasal influenza, MMR, oral polio, varicella, zoster, yellow fever and BCG vaccines) within seven days prior to registration nor have plans to receive such vaccination while on protocol treatment.
  • Patients must not have taken within 14 days prior to registration, be taking, nor plan to take while on protocol treatment, strong CYP3A4 inhibitors, and/or CYP3A4 inducers.
  • No other prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer or other cancer for which the patient has been disease-free for 5 years.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02137837

  Hide Study Locations
Locations
United States, Alaska
Alaska Women's Cancer Care
Anchorage, Alaska, United States, 99508
Anchorage Oncology Centre
Anchorage, Alaska, United States, 99508
Katmai Oncology Group
Anchorage, Alaska, United States, 99508
Providence Alaska Medical Center
Anchorage, Alaska, United States, 99508
Alaska Breast Care and Surgery LLC
Anchorage, Alaska, United States, 99508
United States, Arizona
Virginia G. Piper Cancer Center
Scottsdale, Arizona, United States, 85258
University of Arizona Medical Center - Univ Campus
Tucson, Arizona, United States, 85724
Southern Arizona VA Health Care System
Tucson, Arizona, United States, 85723
University of Arizona Cancer Center - Orange Grove
Tucson, Arizona, United States, 85704
University of Arizona Cancer Center - North Campus
Tucson, Arizona, United States, 85719
United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, California
Providence St. Joseph Medical Ctr/Disney Family CC
Burbank, California, United States, 91505
City of Hope National Medical Center
Duarte, California, United States, 91010
Epic Care - Oakland
Oakland, California, United States, 94612
Bay Area Tumor Institute
Oakland, California, United States, 94609
Summit Medical Center
Oakland, California, United States, 94609
United States, Connecticut
Bridgeport Hospital
Bridgeport, Connecticut, United States, 06610
St. Francis Hospital and Medical Center
Hartford, Connecticut, United States, 06105
Yale University
New Haven, Connecticut, United States, 06520
Yale-New Haven Hospital North Haven Medical Center
North Haven, Connecticut, United States, 06473
United States, Florida
Sacred Heart Hospital
Pensacola, Florida, United States, 32504
Cleveland Clinic - Weston
Weston, Florida, United States, 33331
United States, Georgia
South Georgia Medical Center - Pearlman Cancer Ctr
Valdosta, Georgia, United States, 31602
United States, Hawaii
Oncare Hawaii, Inc - Pali Momi
Aiea, Hawaii, United States, 96701
Pali Momi Medical Center
Aiea, Hawaii, United States, 96701
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States, 96826
Oncare Hawaii Inc-POB I
Honolulu, Hawaii, United States, 96813
Oncare Hawaii, Inc - Kuakini
Honolulu, Hawaii, United States, 96817
University of Hawaii Cancer Center
Honolulu, Hawaii, United States, 96813
Oncare Hawaii, Inc - POB II
Honolulu, Hawaii, United States, 96813
Straub Clinic and Hospital
Honolulu, Hawaii, United States, 96813
Oncare Hawaii, Inc - Liliha
Honolulu, Hawaii, United States, 96817
Wilcox Memorial Hospital and Kauai Medical Clinic
Lihue, Hawaii, United States, 96766
United States, Idaho
St. Alphonsus Regional Medical Center
Boise, Idaho, United States, 83706
Kootenai Medical Center
Coeur D'Alene, Idaho, United States, 83814
Kootenai Cancer Center
Post Falls, Idaho, United States, 83854
Kootenai Cancer Clinic
Sandpoint, Idaho, United States, 83864
United States, Illinois
Heartland Cancer Research NCORP
Decatur, Illinois, United States, 62526
Decatur Memorial Hospital
Decatur, Illinois, United States, 62526
Kishwaukee Community Hospital
DeKalb, Illinois, United States, 60115
Loyola University Stritch School of Medicine
Maywood, Illinois, United States, 60153
Marjorie Weinberg Cancer Center
Melrose Park, Illinois, United States, 60160
Good Samaritan Regional Health Center
Mt. Vernon, Illinois, United States, 62864
Springfield Clinic
Springfield, Illinois, United States, 62703
Memorial Medical Center
Springfield, Illinois, United States, 62781
Central Illinois Hematology Oncology Center
Springfield, Illinois, United States, 62702
United States, Indiana
Reid Hospital and Health Care Services
Richmond, Indiana, United States, 47374
United States, Kansas
Cancer Center of Kansas - Chanute
Chanute, Kansas, United States, 66720
Cancer Center of Kansas - Dodge City
Dodge City, Kansas, United States, 67801
Cancer Center of Kansas - El Dorado
El Dorado, Kansas, United States, 67042
Cancer Center of Kansas - Fort Scott
Fort Scott, Kansas, United States, 66701
Cancer Center of Kansas - Independence
Independence, Kansas, United States, 67301
Cancer Center of Kansas - Kingman
Kingman, Kansas, United States, 67068
Lawrence Memorial Hospital
Lawrence, Kansas, United States, 66044
Cancer Center of Kansas - Liberal
Liberal, Kansas, United States, 67901
Cancer Center of Kansas - Newton
Newton, Kansas, United States, 67114
Cancer Center of Kansas - Parsons
Parsons, Kansas, United States, 67357
Cancer Center of Kansas - Pratt
Pratt, Kansas, United States, 67124
Cancer Center of Kansas - Salina
Salina, Kansas, United States, 67401
Cancer Center of Kansas - Wellington
Wellington, Kansas, United States, 67152
Cancer Center of Kansas - Medical Arts Tower
Wichita, Kansas, United States, 67208
Associates in Women's Health
Wichita, Kansas, United States, 67208
Cancer Center of Kansas - Wichita
Wichita, Kansas, United States, 67214
Via Christi Regional Medical Center
Wichita, Kansas, United States, 67214
Wichita NCI Community Oncology Research Program
Wichita, Kansas, United States, 67214
Cancer Center of Kansas - Winfield
Winfield, Kansas, United States, 67156
United States, Louisiana
De Soto Regional Medical Center
Mansfield, Louisiana, United States, 71052
E.A. Conway Medical Center
Monroe, Louisiana, United States, 71210
Highland Clinic
Shreveport, Louisiana, United States, 71105
Louisiana State University Health Sciences Center
Shreveport, Louisiana, United States, 71130
United States, Maryland
Sinai Hospital of Baltimore
Baltimore, Maryland, United States, 21215
United States, Massachusetts
Beverly Hospital
Beverly, Massachusetts, United States, 01915
Lahey Hospital and Medical Center
Burlington, Massachusetts, United States, 01805
Addison Gilbert Hospital
Gloucester, Massachusetts, United States, 01930
United States, Michigan
Michigan Cancer Research Consortium NCORP
Ann Arbor, Michigan, United States, 48106
St. Joseph Mercy Hospital
Ann Arbor, Michigan, United States, 48106
University of Michigan Medical Center
Ann Arbor, Michigan, United States, 48109
Oakwood Healthcare, Inc.
Dearborn, Michigan, United States, 48123
Wayne State University Medical Center
Detroit, Michigan, United States, 48202
St. John Hospital and Medical Center
Detroit, Michigan, United States, 48236
Genesys Hurley Cancer Institute
Flint, Michigan, United States, 48503
Hurley Medical Center
Flint, Michigan, United States, 48503
William Beaumont Hospital-Grosse Pointe
Grosse Pointe, Michigan, United States, 48230
Allegiance Health
Jackson, Michigan, United States, 49201
Sparrow Health System
Lansing, Michigan, United States, 48909
St. Mary Mercy Hospital
Livonia, Michigan, United States, 48154
MidMichigan Medical Center - Midland
Midland, Michigan, United States, 48670
St Joseph Mercy Hospital - Oakland
Pontiac, Michigan, United States, 48341
St. Joseph Mercy Port Huron
Port Huron, Michigan, United States, 48060
Beaumont Children's Hospital-Royal Oak
Royal Oak, Michigan, United States, 48073
Beaumont NCI Community Oncology Research Program
Royal Oak, Michigan, United States, 48073
St. Mary's Health System
Saginaw, Michigan, United States, 48601
Beaumont Hospital, Troy Campus
Troy, Michigan, United States, 48085
St. John Macomb Hospital
Warren, Michigan, United States, 48093
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
United States, Missouri
Central Care Cancer Ctr-Carrie J. Babb Cancer Ctr
Bolivar, Missouri, United States, 65613
Cox Cancer Center Branson
Branson, Missouri, United States, 65616
Mercy Hospital - Joplin
Joplin, Missouri, United States, 64804
Mercy Clinic Care and Hematology - Rolla
Rolla, Missouri, United States, 65401
PCRMC Bond Clinic
Rolla, Missouri, United States, 65401
Phelps County Regional Medical Center
Rolla, Missouri, United States, 65401
Mercy Hospital Springfield
Springfield, Missouri, United States, 65804
CoxHealth South Hospital
Springfield, Missouri, United States, 65807
Cancer Research for the Ozarks NCORP
Springfield, Missouri, United States, 65804
Mercy Hospital St. Louis
St. Louis, Missouri, United States, 63141
St. Louis Cancer and Breast Institute-South City
St. Louis, Missouri, United States, 63109
Mercy Hospital Washington
Washington, Missouri, United States, 63090
United States, Montana
Billings Clinic Cancer Center
Billings, Montana, United States, 59107
Montana Cancer Consortium NCORP
Billings, Montana, United States, 59101
St. Vincent Hospital
Billings, Montana, United States, 59101
Bozeman Deaconess Hospital
Bozeman, Montana, United States, 59715
St. James Community Hosp and Cancer Treatment Center
Butte, Montana, United States, 59702
Benefis Healthcare West Campus
Great Falls, Montana, United States, 59405
St. Peter's Community Hospital
Helena, Montana, United States, 59601
Kalispell Regional Medical Center
Kalispell, Montana, United States, 59901
St. Patrick Hospital
Missoula, Montana, United States, 59806
Community Medical Center
Missoula, Montana, United States, 59801
United States, Nebraska
Good Samaritan Hospital
Kearney, Nebraska, United States, 68847
United States, North Carolina
Wayne Memorial Hospital
Goldsboro, North Carolina, United States, 27534
Hendersonville Hematology and Oncology at Pardee
Hendersonville, North Carolina, United States, 28739
Park Ridge Health
Hendersonville, North Carolina, United States, 28792
Margaret R. Pardee Memorial Hospital
Hendersonville, North Carolina, United States, 28791
Wilson Medical Center
Wilson, North Carolina, United States, 27893
United States, Ohio
Cleveland Clinic Cancer Center - Beachwood
Beachwood, Ohio, United States, 44122
Strecker Cancer Center-Belpre
Belpre, Ohio, United States, 45714
Adena Regional Medical Center
Chillicothe, Ohio, United States, 45601
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45267
VA Medical Center - Cincinnati
Cincinnati, Ohio, United States, 45220
Cleveland Clinic Cancer Center - Fairview Hospital
Cleveland, Ohio, United States, 44111
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Columbus NCI Community Oncology Research Program
Columbus, Ohio, United States, 43215
Mount Carmel East Hospital
Columbus, Ohio, United States, 43213
Mount Carmel Health Center West
Columbus, Ohio, United States, 43222
The Mark H. Zangmeister Center
Columbus, Ohio, United States, 43219
Dayton NCI Community Oncology Research Program
Dayton, Ohio, United States, 45420
Good Samaritan Hospital and Health Center
Dayton, Ohio, United States, 45406
Samaritan North Health Center
Dayton, Ohio, United States, 45415
VA Medical Center - Dayton
Dayton, Ohio, United States, 45428
Wayne Hospital
Greenville, Ohio, United States, 45331
Cleveland Clinic Cancer Center - Independence
Independence, Ohio, United States, 44131
Kettering Medical Center
Kettering, Ohio, United States, 45429
Fairfield Medical Center
Lancaster, Ohio, United States, 43130
Cleveland Clinic Cancer Center - Mansfield
Mansfield, Ohio, United States, 44906
Marietta Memorial Hospital
Marietta, Ohio, United States, 45750
Hillcrest Hospital Cancer Center
Mayfield Heights, Ohio, United States, 44124
Knox Community Hospital
Mt. Vernon, Ohio, United States, 43050
Licking Memorial Hospital
Newark, Ohio, United States, 43055
Southern Ohio Medical Center
Portsmouth, Ohio, United States, 45662
North Coast Cancer Care, Inc.
Sandusky, Ohio, United States, 44870
Springfield Regional Cancer Center
Springfield, Ohio, United States, 45504
Springfield Regional Medical Center
Springfield, Ohio, United States, 45501
Cleveland Clinic Strongsville Family Health Center
Strongsville, Ohio, United States, 44136
Upper Valley Medical Centers
Troy, Ohio, United States, 45373
South Pointe Hospital
Warrensville Heights, Ohio, United States, 44122
St. Ann's Hospital
Westerville, Ohio, United States, 43081
Cleveland Clinic Cancer Center - Wooster
Wooster, Ohio, United States, 44691
Genesis Healthcare System Cancer Care Center
Zanesville, Ohio, United States, 43701
United States, Oregon
St. Charles Health System
Bend, Oregon, United States, 97701
Clackamas Radiation Oncology Center
Clackamas, Oregon, United States, 97015
Providence Oncology and Hematology Care Southeast
Clackamas, Oregon, United States, 97015
Providence Newberg Medical Center
Newberg, Oregon, United States, 97132
Providence Willamette Falls Medical Center
Oregon City, Oregon, United States, 97045
Providence Portland Medical Center
Portland, Oregon, United States, 97213
Providence St. Vincent Medical Center
Portland, Oregon, United States, 97225
United States, South Carolina
McLeod Regional Medical Center
Florence, South Carolina, United States, 29501
Gibbs Cancer Center-Gaffney
Gaffney, South Carolina, United States, 29341
Gibbs Cancer Center-Pelham
Greer, South Carolina, United States, 29651
Spartanburg Medical Cancer
Spartanburg, South Carolina, United States, 29303
MGC Hematology Oncology-Union
Union, South Carolina, United States, 29379
United States, Tennessee
Wellmont Medical Associates Oncology and Hematology
Bristol, Tennessee, United States, 37620
Wellmont Bristol Regional Medical Center
Bristol, Tennessee, United States, 37620
Wellmont Medical Assoc Onc and Hem-Johnson City
Johnson City, Tennessee, United States, 37604
Wellmont Medical Assoc Onc and Hem-Kingsport
Kingsport, Tennessee, United States, 37660
Holston Valley Hospital and Medical Center
Kingsport, Tennessee, United States, 37660
Thompson Cancer Survival Center
Knoxville, Tennessee, United States, 37916
United States, Texas
Don and Sybil Harrington Cancer Center
Amarillo, Texas, United States, 79106
United States, Utah
University of Utah Medical Center
Salt Lake City, Utah, United States, 84132
United States, Virginia
Southwest VA Regional Cancer Center
Norton, Virginia, United States, 24273
United States, Washington
Island Hospital
Anacortes, Washington, United States, 98221
Auburn Regional Medical Center
Auburn, Washington, United States, 98001
Virginia Mason Bainbridge Island Medical Center
Bainbridge Island, Washington, United States, 98110
Swedish Cancer Inst-Eastside Oncology Hematoly
Bellevue, Washington, United States, 98005
Overlake Hospital Medical Center
Bellevue, Washington, United States, 98004
PeaceHealth St. Joseph Medical Center
Bellingham, Washington, United States, 98225
Swedish Medical Center - Edmonds
Edmonds, Washington, United States, 98026
Virginia Mason Federal Way Medical Center
Federal Way, Washington, United States, 98002
MultiCare Gig Harbor Medical Park
Gig Harbor, Washington, United States, 98335
Tacoma/Valley Radiation Oncology Ctrs-Gig Harbor
Gig Harbor, Washington, United States, 98332
Swedish Cancer Institute-Issaquah
Issaquah, Washington, United States, 98029
PeaceHealth St. John Medical Center
Longview, Washington, United States, 98632
Virginia Mason Lynnwood Medical Center
Lynnwood, Washington, United States, 98036
MultiCare Good Samaritan Hospital
Puyallup, Washington, United States, 98372
Tacoma/Valley Radiation Oncology Ctrs-Puyallup
Puyallup, Washington, United States, 98372
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109
Group Health Cooperative-Seattle
Seattle, Washington, United States, 98112
Pacific Cancer Research Consortium NCORP
Seattle, Washington, United States, 98104
Pacific Medical Center - First Hill
Seattle, Washington, United States, 98104
Swedish Medical Center
Seattle, Washington, United States, 98104
Minor and James Medical, PLLC
Seattle, Washington, United States, 98104
Swedish Medical Center - Ballard Campus
Seattle, Washington, United States, 98107
Mary Bridge Children's Hospital and Health Center
Tacoma, Washington, United States, 98405
Multicare Health System
Tacoma, Washington, United States, 98415
Northwest NCI Community Oncology Research Program
Tacoma, Washington, United States, 98405
Tacoma/Valley Radiation Oncology Ctrs-Jackson Hill
Tacoma, Washington, United States, 97405
Tacoma/Valley Radiation Oncology Ctrs-Saint Joe's
Tacoma, Washington, United States, 98405
PeaceHealth Southwest Medical Center
Vancouver, Washington, United States, 98668
United States, Wyoming
Billings Clinic-Cody
Cody, Wyoming, United States, 82414
Welch Cancer Center - Sheridan Memorial Hospital
Sheridan, Wyoming, United States, 82801
Sponsors and Collaborators
Southwest Oncology Group
AstraZeneca
Novartis
Investigators
Study Chair: George Somlo, M.D. City of Hope Cancer Center
  More Information

No publications provided

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT02137837     History of Changes
Other Study ID Numbers: S1222
Study First Received: May 12, 2014
Last Updated: May 20, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Southwest Oncology Group:
Metastatic breast cancer
Invasive breast carcinoma
estrogen receptor-positive breast cancer
HER2-negative breast cancer
Stage IV breast cancer
progesterone receptor-positive breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Anastrozole
Estradiol
Everolimus
Fulvestrant
Sirolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Aromatase Inhibitors
Enzyme Inhibitors
Estrogen Antagonists
Estrogen Receptor Modulators
Estrogens
Hormone Antagonists
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on July 05, 2015