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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Southwest Oncology Group
Sponsor:
Collaborators:
AstraZeneca
Novartis
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT02137837
First received: May 12, 2014
Last updated: August 19, 2014
Last verified: August 2014
  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

Contacts
Contact: Megan M Hardin 2106148808 ext 1014 mhardin@swog.org
Contact: Dana Sparks, MAT 2106148808 ext 1004 dsparks@swog.org

  Hide Study Locations
Locations
United States, Arizona
Virginia G. Piper Cancer Center Recruiting
Scottsdale, Arizona, United States, 85258
Southern Arizona VA Health Care System Recruiting
Tucson, Arizona, United States, 85723
University of Arizona Cancer Center - North Campus Recruiting
Tucson, Arizona, United States, 85719
University of Arizona Cancer Center - Orange Grove Recruiting
Tucson, Arizona, United States, 85704
University of Arizona Medical Center - Univ Campus Recruiting
Tucson, Arizona, United States, 85724
Contact: Henry F. Manspeaker, MHSc    520-603-2652    peteman@email.arizona.edu   
Principal Investigator: Lee D. Cranmer, MD,PhD         
United States, California
City of Hope National Medical Center Recruiting
Duarte, California, United States, 91010
Contact: Dina M. Johnson, CCRA    626-359-8111 ext 62846    djohnson@coh.org   
Principal Investigator: Joanne E. Mortimer, MD         
Contra Costa Regional Medical Center Recruiting
Martinez, California, United States, 94553
El Camino Hospital Recruiting
Mountain View, California, United States, 94040
Alameda County Medical Ctr - Highland General Hosp Recruiting
Oakland, California, United States, 94602
Epic Care - Oakland Recruiting
Oakland, California, United States, 94612
Bay Area Tumor Institute CCOP Recruiting
Oakland, California, United States, 94609
Contact: Sharon M. Omega    510-465-8016    somega@bati.org   
Principal Investigator: Lili X. Wang, MD         
Summit Medical Center Recruiting
Oakland, California, United States, 94609
Doctors Medical Center Recruiting
San Pablo, California, United States, 94806
United States, Connecticut
St. Francis Hospital and Medical Center Recruiting
Hartford, Connecticut, United States, 06105
United States, Florida
Sacred Heart Hospital Recruiting
Pensacola, Florida, United States, 32513
Sacred Heart Medical Oncology Group - Davis Hwy Recruiting
Pensacola, Florida, United States, 32514
Contact: Elizabeth E. Brou, RN    850-416-4611    eebrou@shhpens.org   
Principal Investigator: Ranjith B. Dissanayake, MD         
United States, Georgia
St. Josephs/Candler Health System, Inc Recruiting
Savannah, Georgia, United States, 31405
Contact: Alaina Louise Underberg, MHSA    912-819-5778    underberga@sjchs.org   
Principal Investigator: Howard A. Zaren, MD         
South Georgia Medical Center - Pearlman Cancer Ctr Recruiting
Valdosta, Georgia, United States, 31602
Contact: Mary Ann Heddon, RN,MSN    229-259-4628    maryann.heddon@sgmc.org   
Principal Investigator: Samuel Ofori, MD         
United States, Hawaii
Pali Momi Medical Center Recruiting
Aiea, Hawaii, United States, 96701
Oncare Hawaii, Inc - Pali Momi Recruiting
Aiea, Hawaii, United States, 96701
Kapiolani Medical Center for Women and Children Recruiting
Honolulu, Hawaii, United States, 96826
Straub Clinic and Hospital Recruiting
Honolulu, Hawaii, United States, 96813
Oncare Hawaii, Inc - Kuakini Recruiting
Honolulu, Hawaii, United States, 96817
Oncare Hawaii, Inc - Liliha Recruiting
Honolulu, Hawaii, United States, 96817
Oncare Hawaii, Inc - POB II Recruiting
Honolulu, Hawaii, United States, 96813
University of Hawaii MBCCOP Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Virginia McMahon, CCRP    808-586-2979    virginia@cc.hawaii.edu   
Principal Investigator: Jeffrey L. Berenberg, MD         
Castle Medical Center Recruiting
Kailua, Hawaii, United States, 96734
Kauai Medical Clinic Recruiting
Lihue, Hawaii, United States, 96766
Maui Memorial Medical Center Recruiting
Wailuku, Hawaii, United States, 96793
United States, Illinois
Central Illinois CCOP Recruiting
Decatur, Illinois, United States, 62526
Contact: Peggy S. Wisher, RN,BSN    217-876-4755    pwisher@dmhhs.org   
Principal Investigator: James L. Wade, MD         
Decatur Memorial Hospital Recruiting
Decatur, Illinois, United States, 62526
Kishwaukee Community Hospital Recruiting
DeKalb, Illinois, United States, 60115
Loyola University Stritch School of Medicine Recruiting
Maywood, Illinois, United States, 60153
Contact: Cecilia Petrowsky, RN,MSN    708-327-3306    cpetrow@lumc.edu   
Principal Investigator: Patrick J. Stiff, MD         
Marjorie Weinberg Cancer Center Recruiting
Melrose Park, Illinois, United States, 60160
Central Illinois Hematology Oncology Center Recruiting
Springfield, Illinois, United States, 60702
Memorial Medical Center Recruiting
Springfield, Illinois, United States, 62781
Springfield Clinic Recruiting
Springfield, Illinois, United States, 62703
United States, Indiana
Reid Hospital and Health Care Services Recruiting
Richmond, Indiana, United States, 47374
United States, Kansas
Cancer Center of Kansas - Chanute Recruiting
Chanute, Kansas, United States, 66720
Cancer Center of Kansas - Dodge City Recruiting
Dodge City, Kansas, United States, 67801
Cancer Center of Kansas - El Dorado Recruiting
El Dorado, Kansas, United States, 67042
Cancer Center of Kansas - Fort Scott Recruiting
Fort Scott, Kansas, United States, 66701
Cancer Center of Kansas - Independence Recruiting
Independence, Kansas, United States, 67301
Cancer Center of Kansas - Kingman Recruiting
Kingman, Kansas, United States, 67068
Lawrence Memorial Hospital Recruiting
Lawrence, Kansas, United States, 66044
Cancer Center of Kansas - Liberal Recruiting
Liberal, Kansas, United States, 67901
Cancer Center of Kansas - Newton Recruiting
Newton, Kansas, United States, 67114
Cancer Center of Kansas - Parsons Recruiting
Parsons, Kansas, United States, 67357
Cancer Center of Kansas - Pratt Recruiting
Pratt, Kansas, United States, 67124
Cancer Center of Kansas - Salina Recruiting
Salina, Kansas, United States, 67401
Cancer Center of Kansas - Wellington Recruiting
Wellington, Kansas, United States, 67152
Associates in Womens Health Recruiting
Wichita, Kansas, United States, 67208
Cancer Center of Kansas - Medical Arts Tower Recruiting
Wichita, Kansas, United States, 67208
Wichita State University Recruiting
Wichita, Kansas, United States, 67208
Wichita CCOP Recruiting
Wichita, Kansas, United States, 67214
Contact: Keisha C. Humphries, RN,BSN    316-393-1300    keisha.humphries@viachristi.org   
Principal Investigator: Shaker R. Dakhil, MD         
Via Christi Regional Medical Center Recruiting
Wichita, Kansas, United States, 67214
Cancer Center of Kansas - Wichita Recruiting
Wichita, Kansas, United States, 67214
Cancer Center of Kansas - Winfield Recruiting
Winfield, Kansas, United States, 67156
United States, Kentucky
Baptist Health Corbin Recruiting
Corbin, Kentucky, United States, 40701
Hardin Memorial Hospital Recruiting
Elizabethtown, Kentucky, United States, 42701
Baptist Health Lexington Recruiting
Lexington, Kentucky, United States, 40503
Contact: Heather L. Tudor, BS    859-260-3196    heather.tudor@bhsi.com   
Principal Investigator: Lee G. Hicks, MD         
United States, Louisiana
De Soto Regional Medical Center Recruiting
Mansfield, Louisiana, United States, 71052
E.A. Conway Medical Center Recruiting
Monroe, Louisiana, United States, 71210
Highland Clinic Recruiting
Shreveport, Louisiana, United States, 71105
LSUHSC-Shreveport Minority Based CCOP Recruiting
Shreveport, Louisiana, United States, 71130
Contact: John P. Rowell, RN,MSN    318-813-1422    jrowel@lsuhsc.edu   
Principal Investigator: Gary V. Burton, MD         
United States, Maryland
Sinai Hospital of Baltimore Recruiting
Baltimore, Maryland, United States, 21215
Contact: Judy H. Bosley, RN,BSN    410-601-4392    jbosley@lifebridgehealth.org   
Principal Investigator: Mukund S. Didolkar, MD         
United States, Massachusetts
Beverly Hospital Recruiting
Beverly, Massachusetts, United States, 01915
Lahey Hospital and Medical Center Recruiting
Burlington, Massachusetts, United States, 01805
Contact: Julie C. Roache    781-744-3055    julie.roache@lahey.org   
Principal Investigator: Paul J. Hesketh, MD         
Addison Gilbert Hospital Recruiting
Gloucester, Massachusetts, United States, 01930
United States, Michigan
Michigan Cancer Research Consortium CCOP Recruiting
Ann Arbor, Michigan, United States, 48106
Contact: Beth LaVasseur, RN,MS    734-712-5658    lavasseb@trinity-health.org   
Principal Investigator: Philip J. Stella, MD         
St. Joseph Mercy Hospital Recruiting
Ann Arbor, Michigan, United States, 48106
University of Michigan Medical Center Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Annette T. Betley    734-998-7182    abetley@med.umich.edu   
Principal Investigator: Mark M. Zalupski, MD         
St. Mary Mercy Hospital Recruiting
Livonia, Michigan, United States, 48154
MidMichigan Medical Center - Midland Recruiting
Midland, Michigan, United States, 48670
Contact: Alana M. DAmbrosio-Berry, RN    989-839-1678    alana.dambrosio-berry@midmichigan.org   
Principal Investigator: Michel R. Hurtubise, MD         
St Joseph Mercy Hospital - Oakland Recruiting
Pontiac, Michigan, United States, 48341
St. John Macomb Hospital Recruiting
Warren, Michigan, United States, 48093
United States, Missouri
Central Care Cancer Ctr-Carrie J. Babb Cancer Ctr Recruiting
Bolivar, Missouri, United States, 65613
Cox Cancer Center Branson Recruiting
Branson, Missouri, United States, 65616
Phelps County Regional Medical Center Recruiting
Rolla, Missouri, United States, 65401
Ozark Hlth Ventures-Cancer Research for the Ozarks Recruiting
Springfield, Missouri, United States, 65804
Contact: Marilyn Bauer, RN,MED    417-269-4880    marilyn.bauer@coxhealth.com   
Principal Investigator: Jay W. Carlson, DO,MS         
CoxHealth South Hospital Recruiting
Springfield, Missouri, United States, 65807
United States, Montana
St. Vincent Hospital Recruiting
Billings, Montana, United States, 59101
Billings Clinic Downtown Recruiting
Billings, Montana, United States, 59107
Montana Cancer Consortium CCOP Recruiting
Billings, Montana, United States, 59101
Contact: Amanda R. Dinsdale, CCRC    406-237-5463    adinsdale@mtcancer.org   
Principal Investigator: Benjamin T. Marchello, MD         
Bozeman Deaconess Hospital Recruiting
Bozeman, Montana, United States, 59715
St. James Community Hosp and Cancer Treatment Center Recruiting
Butte, Montana, United States, 59702
St. Peters Community Hospital Recruiting
Helena, Montana, United States, 59601
St. Patrick Hospital Recruiting
Missoula, Montana, United States, 59806
Montana Cancer Specialists Recruiting
Missoula, Montana, United States, 59802
United States, North Carolina
Wayne Memorial Hospital Recruiting
Goldsboro, North Carolina, United States, 27534
Margaret R. Pardee Memorial Hospital Recruiting
Hendersonville, North Carolina, United States, 28791
Hendersonville Hematology and Oncology at Pardee Recruiting
Hendersonville, North Carolina, United States, 28739
Wilson Medical Center Recruiting
Wilson, North Carolina, United States, 27893
United States, Ohio
Strecker Cancer Center-Belpre Recruiting
Belpre, Ohio, United States, 45714
Adena Regional Medical Center Recruiting
Chillicothe, Ohio, United States, 45601
Columbus CCOP Recruiting
Columbus, Ohio, United States, 43215
Contact: Deborah A. Halk, RN    614-488-3310    debby@columbusccop.org   
Principal Investigator: J. Philip Kuebler, MD,PhD         
Columbus Oncology and Hematology Associates, Inc. Recruiting
Columbus, Ohio, United States, 43214
Mount Carmel Health System Recruiting
Columbus, Ohio, United States, 43222
Grant Medical Center Recruiting
Columbus, Ohio, United States, 43215
Doctors Hospital Recruiting
Columbus, Ohio, United States, 43201
The Mark H. Zangmeister Center Recruiting
Columbus, Ohio, United States, 43219
Samaritan North Health Center Recruiting
Dayton, Ohio, United States, 45415
Good Samaritan Hospital and Health Center Recruiting
Dayton, Ohio, United States, 45406
Dayton Clinical Oncology Program CCOP Recruiting
Dayton, Ohio, United States, 45420
Contact: Amy Dempe    937-775-1364    amy.dempe@wright.edu   
Principal Investigator: Howard M. Gross, MD         
VA Medical Center - Dayton Recruiting
Dayton, Ohio, United States, 45428
Delaware Health Center - Grady Cancer Center Recruiting
Delaware, Ohio, United States, 43015
Grady Memorial Hospital Recruiting
Delaware, Ohio, United States, 43015
Atrium Medical Center Recruiting
Franklin, Ohio, United States, 45005
Wayne Hospital Recruiting
Greenville, Ohio, United States, 45331
Kettering Medical Center Recruiting
Kettering, Ohio, United States, 45429
Fairfield Medical Center Recruiting
Lancaster, Ohio, United States, 43130
Marietta Memorial Hospital Recruiting
Marietta, Ohio, United States, 45750
Knox Community Hospital Recruiting
Mt. Vernon, Ohio, United States, 43050
Licking Memorial Hospital Recruiting
Newark, Ohio, United States, 43055
Southern Ohio Medical Center Recruiting
Portsmouth, Ohio, United States, 45662
Springfield Regional Medical Center Recruiting
Springfield, Ohio, United States, 45501
Upper Valley Medical Centers Recruiting
Troy, Ohio, United States, 45373
St. Anns Hospital Recruiting
Westerville, Ohio, United States, 43081
Genesis Healthcare System Recruiting
Zanesville, Ohio, United States, 43701
United States, Oregon
Clackamas Radiation Oncology Center Recruiting
Clackamas, Oregon, United States, 97015
Providence Milwaukie Hospital Recruiting
Milwaukie, Oregon, United States, 97222
Providence Newberg Medical Center Recruiting
Newberg, Oregon, United States, 97132
Providence Willamette Falls Medical Center Recruiting
Oregon City, Oregon, United States, 97045
Providence Portland Medical Center Recruiting
Portland, Oregon, United States, 97213
Providence St. Vincent Medical Center Recruiting
Portland, Oregon, United States, 97225
Western Oncology Research Consortium (WORC) CCOP Recruiting
Portland, Oregon, United States, 97213
Contact: Julie L. Cramer    503-215-9948    julie.cramer@providence.org   
Principal Investigator: Alison K. Conlin, MD         
United States, South Carolina
McLeod Regional Medical Center Recruiting
Florence, South Carolina, United States, 29501
United States, Tennessee
Wellmont Medical Associates-Oncology and Hematology Recruiting
Bristol, Tennessee, United States, 37620
Wellmont Bristol Regional Medical Center Recruiting
Bristol, Tennessee, United States, 37620
Holston Valley Hospital and Medical Center Recruiting
Kingsport, Tennessee, United States, 37660
United States, Texas
Don and Sybil Harrington Cancer Center Recruiting
Amarillo, Texas, United States, 79106
Contact: Gina D. Cravey, RN    806-212-1985    gcravey@harringtoncc.org   
Principal Investigator: Stewart A. Sharp, MD         
United States, Washington
Island Hospital Recruiting
Anacortes, Washington, United States, 98221
Contact: Enid S. Oates, RN,OCN    360-299-4256    eoates@islandhospital.org   
Principal Investigator: George F. Gjerset, MD         
PeaceHealth St. Joseph Medical Center Recruiting
Bellingham, Washington, United States, 98225
Contact: Cheryl R. Patz, RN,OCN    360-788-8238    cpatz@peacehealth.org   
Principal Investigator: Michael A. Taylor, MD         
Harrison HealthPartners Hematology and Oncology Recruiting
Bremerton, Washington, United States, 98310
Contact: Genean M. Page, RN,OCN    360-479-6154    genean.page@harrisonmedical.org   
Principal Investigator: Joseph L. Johnson, MD         
Highline Cancer Center Recruiting
Burien, Washington, United States, 98166
Contact: Lynn Gemmell, MBA    206-439-5572    lgemmell@highlinemedical.org   
Principal Investigator: Steven S. Ginsberg, MD         
Swedish Medical Center - Edmonds Recruiting
Edmonds, Washington, United States, 98026
Swedish Cancer Institute-Issaquah Recruiting
Issaquah, Washington, United States, 98029
Harrison HealthPartners Hematology and Oncology Recruiting
Poulsbo, Washington, United States, 98370
Swedish Medical Center - Ballard Campus Recruiting
Seattle, Washington, United States, 98107
Puget Sound Oncology Consortium Recruiting
Seattle, Washington, United States, 98104
Contact: Patra K. Grevstad, RN,MN    206-386-2442    patra.grevstad@swedish.org   
Principal Investigator: Gary E. Goodman, MD         
Group Health Cooperative-Seattle Recruiting
Seattle, Washington, United States, 98112
Swedish Medical Center Recruiting
Seattle, Washington, United States, 98104
Minor and James Medical, PLLC Recruiting
Seattle, Washington, United States, 98104
Contact: Christina M. Brennan, CCRP    206-386-2450    christina.brennan@swedish.org   
Principal Investigator: William P. Hammond, MD         
PeaceHealth Southwest Medical Center Recruiting
Vancouver, Washington, United States, 98668
United States, Wyoming
Rocky Mountain Oncology Center Recruiting
Casper, Wyoming, United States, 82609
Welch Cancer Center - Sheridan Memorial Hospital Recruiting
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: August 19, 2014
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
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Everolimus
Sirolimus
Anastrozole
Fulvestrant
Estradiol
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Antineoplastic Agents, Hormonal
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Estrogens
Hormones

ClinicalTrials.gov processed this record on September 18, 2014