AzTrials
AzTrials

Breast CancerPhase 3NCT02137837

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

A Phase 3 study testing Fulvestrant, Anastrozole and Everolimus in people with Breast Cancer, run by SWOG Cancer Research Network at 223 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
Fulvestrant, Anastrozole and Everolimus
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
37 participants
Where
223 sitesUnited States
Study dates
May 2014to 31 Dec 2019
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult
  • 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.

Trial locations and contacts

223 sites in 1 country.

223 sites in 1 country

United States223 sites

  • Oncare Hawaii, Inc - Pali Momi

    ‘Aiea, Hawaii, 96701

  • Pali Momi Medical Center

    ‘Aiea, Hawaii, 96701

  • Don and Sybil Harrington Cancer Center

    Amarillo, Texas, 79106

  • Island Hospital

    Anacortes, Washington, 98221

  • Alaska Breast Care and Surgery LLC

    Anchorage, Alaska, 99508

  • Alaska Women's Cancer Care

    Anchorage, Alaska, 99508

  • Anchorage Oncology Centre

    Anchorage, Alaska, 99508

  • Katmai Oncology Group

    Anchorage, Alaska, 99508

  • Providence Alaska Medical Center

    Anchorage, Alaska, 99508

  • Michigan Cancer Research Consortium NCORP

    Ann Arbor, Michigan, 48106

  • St. Joseph Mercy Hospital

    Ann Arbor, Michigan, 48106

  • University of Michigan Medical Center

    Ann Arbor, Michigan, 48109

  • Auburn Regional Medical Center

    Auburn, Washington, 98001

  • Virginia Mason Bainbridge Island Medical Center

    Bainbridge Island, Washington, 98110

  • Sinai Hospital of Baltimore

    Baltimore, Maryland, 21215

  • Cleveland Clinic Cancer Center - Beachwood

    Beachwood, Ohio, 44122

  • Overlake Hospital Medical Center

    Bellevue, Washington, 98004

  • Swedish Cancer Inst-Eastside Oncology Hematoly

    Bellevue, Washington, 98005

  • PeaceHealth St. Joseph Medical Center

    Bellingham, Washington, 98225

  • Strecker Cancer Center-Belpre

    Belpre, Ohio, 45714

  • St. Charles Health System

    Bend, Oregon, 97701

  • Beverly Hospital

    Beverly, Massachusetts, 01915

  • Montana Cancer Consortium NCORP

    Billings, Montana, 59101

  • Billings Clinic Cancer Center

    Billings, Montana, 59107

  • St. Alphonsus Regional Medical Center

    Boise, Idaho, 83706

  • Central Care Cancer Ctr-Carrie J. Babb Cancer Ctr

    Bolivar, Missouri, 65613

  • Bozeman Deaconess Hospital

    Bozeman, Montana, 59715

  • Cox Cancer Center Branson

    Branson, Missouri, 65616

  • Bridgeport Hospital

    Bridgeport, Connecticut, 06610

  • Wellmont Bristol Regional Medical Center

    Bristol, Tennessee, 37620

  • Wellmont Medical Associates Oncology and Hematology

    Bristol, Tennessee, 37620

  • Providence St. Joseph Medical Ctr/Disney Family CC

    Burbank, California, 91505

  • Lahey Hospital and Medical Center

    Burlington, Massachusetts, 01805

  • St. James Community Hosp and Cancer Treatment Center

    Butte, Montana, 59702

  • St. Francis Medical Center

    Cape Girardeau, Missouri, 63701

  • Centralia Oncology Clinic

    Centralia, Illinois, 62801

  • Cancer Center of Kansas - Chanute

    Chanute, Kansas, 66720

  • Adena Regional Medical Center

    Chillicothe, Ohio, 45601

  • VA Medical Center - Cincinnati

    Cincinnati, Ohio, 45220

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45267

  • Clackamas Radiation Oncology Center

    Clackamas, Oregon, 97015

  • Providence Oncology and Hematology Care Southeast

    Clackamas, Oregon, 97015

  • Cleveland Clinic Cancer Center - Fairview Hospital

    Cleveland, Ohio, 44111

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Southeastern Medical Oncology Center-Clinton

    Clinton, North Carolina, 28328

  • Billings Clinic-Cody

    Cody, Wyoming, 82414

  • Kootenai Medical Center

    Coeur d'Alene, Idaho, 83814

  • Mount Carmel East Hospital

    Columbus, Ohio, 43213

  • Columbus NCI Community Oncology Research Program

    Columbus, Ohio, 43215

  • The Mark H. Zangmeister Center

    Columbus, Ohio, 43219

  • Mount Carmel Health Center West

    Columbus, Ohio, 43222

  • City of Hope-Corona

    Corona, California, 92879

  • Good Samaritan Hospital and Health Center

    Dayton, Ohio, 45406

  • Samaritan North Health Center

    Dayton, Ohio, 45415

  • Dayton NCI Community Oncology Research Program

    Dayton, Ohio, 45420

  • VA Medical Center - Dayton

    Dayton, Ohio, 45428

  • Oakwood Healthcare, Inc.

    Dearborn, Michigan, 48123

  • Cancer Care Specialists of Central Illinois

    Decatur, Illinois, 62526

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • Heartland Cancer Research NCORP

    Decatur, Illinois, 62526

  • Kishwaukee Community Hospital

    DeKalb, Illinois, 60115

  • Wayne State University Medical Center

    Detroit, Michigan, 48202

  • St. John Hospital and Medical Center

    Detroit, Michigan, 48236

  • Cancer Center of Kansas - Dodge City

    Dodge City, Kansas, 67801

  • City of Hope National Medical Center

    Duarte, California, 91010

  • Swedish Medical Center - Edmonds

    Edmonds, Washington, 98026

  • Crossroads Cancer Center

    Effingham, Illinois, 62401

  • Cancer Center of Kansas - El Dorado

    El Dorado, Kansas, 67042

  • Virginia Mason Federal Way Medical Center

    Federal Way, Washington, 98002

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

  • Hurley Medical Center

    Flint, Michigan, 48503

  • McLeod Regional Medical Center

    Florence, South Carolina, 29501

  • Cancer Center of Kansas - Fort Scott

    Fort Scott, Kansas, 66701

  • Gibbs Cancer Center-Gaffney

    Gaffney, South Carolina, 29341

  • Tacoma/Valley Radiation Oncology Ctrs-Gig Harbor

    Gig Harbor, Washington, 98332

  • MultiCare Gig Harbor Medical Park

    Gig Harbor, Washington, 98335

  • Addison Gilbert Hospital

    Gloucester, Massachusetts, 01930

  • Southeastern Medical Oncology Center-Goldsboro

    Goldsboro, North Carolina, 27534

  • Wayne Memorial Hospital

    Goldsboro, North Carolina, 27534

  • Benefis Healthcare West Campus

    Great Falls, Montana, 59405

  • Wayne Hospital

    Greenville, Ohio, 45331

  • Gibbs Cancer Center-Pelham

    Greer, South Carolina, 29651

  • William Beaumont Hospital-Grosse Pointe

    Grosse Pointe, Michigan, 48230

  • St. Francis Hospital and Medical Center

    Hartford, Connecticut, 06105

  • St. Peter's Community Hospital

    Helena, Montana, 59601

  • Hendersonville Hematology and Oncology at Pardee

    Hendersonville, North Carolina, 28739

  • Margaret R. Pardee Memorial Hospital

    Hendersonville, North Carolina, 28791

  • Park Ridge Health

    Hendersonville, North Carolina, 28792

  • Oncare Hawaii Inc-POB I

    Honolulu, Hawaii, 96813

  • Oncare Hawaii, Inc - POB II

    Honolulu, Hawaii, 96813

  • Straub Clinic and Hospital

    Honolulu, Hawaii, 96813

  • University of Hawaii Cancer Center

    Honolulu, Hawaii, 96813

  • Oncare Hawaii, Inc - Kuakini

    Honolulu, Hawaii, 96817

  • Oncare Hawaii, Inc - Liliha

    Honolulu, Hawaii, 96817

  • Kapiolani Medical Center for Women and Children

    Honolulu, Hawaii, 96826

  • Cancer Center of Kansas - Independence

    Independence, Kansas, 67301

  • Cleveland Clinic Cancer Center - Independence

    Independence, Ohio, 44131

  • Swedish Cancer Institute-Issaquah

    Issaquah, Washington, 98029

  • Allegiance Health

    Jackson, Michigan, 49201

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • Southeastern Medical Oncology Center-Jacksonville

    Jacksonville, North Carolina, 28546

  • Wellmont Medical Assoc Onc and Hem-Johnson City

    Johnson City, Tennessee, 37604

  • Mercy Hospital - Joplin

    Joplin, Missouri, 64804

  • Kalispell Regional Medical Center

    Kalispell, Montana, 59901

  • CHI Health Good Samaritan Hospital

    Kearney, Nebraska, 68847

  • Kettering Medical Center

    Kettering, Ohio, 45429

  • Cancer Center of Kansas - Kingman

    Kingman, Kansas, 67068

  • Holston Valley Hospital and Medical Center

    Kingsport, Tennessee, 37660

  • Wellmont Medical Assoc Onc and Hem-Kingsport

    Kingsport, Tennessee, 37660

  • Thompson Cancer Survival Center

    Knoxville, Tennessee, 37916

  • City of Hope Antelope Valley

    Lancaster, California, 93534

  • Fairfield Medical Center

    Lancaster, Ohio, 43130

  • Sparrow Health System

    Lansing, Michigan, 48909

  • Lawrence Memorial Hospital

    Lawrence, Kansas, 66044

  • Cancer Center of Kansas - Liberal

    Liberal, Kansas, 67901

  • Wilcox Memorial Hospital and Kauai Medical Clinic

    Lihue, Hawaii, 96766

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • St. Mary Mercy Hospital

    Livonia, Michigan, 48154

  • PeaceHealth St. John Medical Center

    Longview, Washington, 98632

  • Virginia Mason Lynnwood Medical Center

    Lynnwood, Washington, 98036

  • De Soto Regional Medical Center

    Mansfield, Louisiana, 71052

  • Cleveland Clinic Cancer Center - Mansfield

    Mansfield, Ohio, 44906

  • Marietta Memorial Hospital

    Marietta, Ohio, 45750

  • Hillcrest Hospital Cancer Center

    Mayfield Heights, Ohio, 44124

  • Loyola University Stritch School of Medicine

    Maywood, Illinois, 60153

  • Marjorie Weinberg Cancer Center

    Melrose Park, Illinois, 60160

  • MidMichigan Medical Center - Midland

    Midland, Michigan, 48670

  • Community Medical Center

    Missoula, Montana, 59801

  • St. Patrick Hospital

    Missoula, Montana, 59806

  • University Health Conway

    Monroe, Louisiana, 71210

  • Good Samaritan Regional Health Center

    Mount Vernon, Illinois, 62864

  • Knox Community Hospital

    Mount Vernon, Ohio, 43050

  • Yale University

    New Haven, Connecticut, 06520

  • Licking Memorial Hospital

    Newark, Ohio, 43055

  • Providence Newberg Medical Center

    Newberg, Oregon, 97132

  • Cancer Center of Kansas - Newton

    Newton, Kansas, 67114

  • Yale-New Haven Hospital North Haven Medical Center

    North Haven, Connecticut, 06473

  • Southwest Virginia Cancer Center

    Norton, Virginia, 24273

  • Bay Area Tumor Institute

    Oakland, California, 94609

  • Summit Medical Center

    Oakland, California, 94609

  • Epic Care - Oakland

    Oakland, California, 94612

  • Providence Willamette Falls Medical Center

    Oregon City, Oregon, 97045

  • Cancer Center of Kansas - Parsons

    Parsons, Kansas, 67357

  • Sacred Heart Hospital

    Pensacola, Florida, 32504

  • St Joseph Mercy Hospital - Oakland

    Pontiac, Michigan, 48341

  • St. Joseph Mercy Port Huron

    Port Huron, Michigan, 48060

  • Providence Portland Medical Center

    Portland, Oregon, 97213

  • Providence St. Vincent Medical Center

    Portland, Oregon, 97225

  • Southern Ohio Medical Center

    Portsmouth, Ohio, 45662

  • Kootenai Cancer Center

    Post Falls, Idaho, 83854

  • Cancer Center of Kansas - Pratt

    Pratt, Kansas, 67124

  • MultiCare Good Samaritan Hospital

    Puyallup, Washington, 98372

  • Tacoma/Valley Radiation Oncology Ctrs-Puyallup

    Puyallup, Washington, 98372

  • Reid Hospital and Health Care Services

    Richmond, Indiana, 47374

  • Mercy Clinic Care and Hematology - Rolla

    Rolla, Missouri, 65401

  • PCRMC Bond Clinic

    Rolla, Missouri, 65401

  • Phelps County Regional Medical Center

    Rolla, Missouri, 65401

  • Beaumont Children's Hospital-Royal Oak

    Royal Oak, Michigan, 48073

  • Beaumont NCI Community Oncology Research Program

    Royal Oak, Michigan, 48073

  • St. Mary's Health System

    Saginaw, Michigan, 48601

  • Cancer Center of Kansas - Salina

    Salina, Kansas, 67401

  • University of Utah Medical Center

    Salt Lake City, Utah, 84132

  • Kootenai Cancer Clinic

    Sandpoint, Idaho, 83864

  • North Coast Cancer Care, Inc.

    Sandusky, Ohio, 44870

  • Virginia G. Piper Cancer Center

    Scottsdale, Arizona, 85258

  • Virginia Mason Medical Center

    Seattle, Washington, 98101

  • Minor and James Medical, PLLC

    Seattle, Washington, 98104

  • Pacific Cancer Research Consortium NCORP

    Seattle, Washington, 98104

  • Pacific Medical Center - First Hill

    Seattle, Washington, 98104

  • Swedish Medical Center

    Seattle, Washington, 98104

  • Swedish Medical Center - Ballard Campus

    Seattle, Washington, 98107

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109

  • Group Health Cooperative-Seattle

    Seattle, Washington, 98112

  • Welch Cancer Center - Sheridan Memorial Hospital

    Sheridan, Wyoming, 82801

  • Highland Clinic

    Shreveport, Louisiana, 71105

  • Louisiana State University Health Sciences Center

    Shreveport, Louisiana, 71130

  • City of Hope South Pasadena

    South Pasadena, California, 91030

  • Spartanburg Medical Cancer

    Spartanburg, South Carolina, 29303

  • Central Illinois Hematology Oncology Center

    Springfield, Illinois, 62702

  • Springfield Clinic

    Springfield, Illinois, 62703

  • Memorial Medical Center

    Springfield, Illinois, 62781

  • Cancer Research for the Ozarks NCORP

    Springfield, Missouri, 65804

  • Mercy Hospital Springfield

    Springfield, Missouri, 65804

  • CoxHealth South Hospital

    Springfield, Missouri, 65807

  • Springfield Regional Medical Center

    Springfield, Ohio, 45501

  • Springfield Regional Cancer Center

    Springfield, Ohio, 45504

  • St. Louis Cancer and Breast Institute-South City

    St Louis, Missouri, 63109

  • Christian Hospital

    St Louis, Missouri, 63136

  • Mercy Hospital St. Louis

    St Louis, Missouri, 63141

  • Cleveland Clinic Strongsville Family Health Center

    Strongsville, Ohio, 44136

  • Cancer Care Specialists of Illinois-Swansea

    Swansea, Illinois, 62226

  • Tacoma/Valley Radiation Oncology Ctrs-Jackson Hill

    Tacoma, Washington, 97405

  • Mary Bridge Children's Hospital and Health Center

    Tacoma, Washington, 98405

  • MultiCare Tacoma General Hospital

    Tacoma, Washington, 98405

  • Northwest NCI Community Oncology Research Program

    Tacoma, Washington, 98405

  • Tacoma/Valley Radiation Oncology Ctrs-Saint Joe's

    Tacoma, Washington, 98405

  • Multicare Health System

    Tacoma, Washington, 98415

  • Beaumont Hospital, Troy Campus

    Troy, Michigan, 48085

  • Upper Valley Medical Centers

    Troy, Ohio, 45373

  • University of Arizona Cancer Center - Orange Grove

    Tucson, Arizona, 85704

  • University of Arizona Cancer Center - North Campus

    Tucson, Arizona, 85719

  • Southern Arizona VA Health Care System

    Tucson, Arizona, 85723

  • University of Arizona Medical Center - Univ Campus

    Tucson, Arizona, 85724

  • MGC Hematology Oncology-Union

    Union, South Carolina, 29379

  • South Georgia Medical Center - Pearlman Cancer Ctr

    Valdosta, Georgia, 31602

  • PeaceHealth Southwest Medical Center

    Vancouver, Washington, 98668

  • St. John Macomb Hospital

    Warren, Michigan, 48093

  • South Pointe Hospital

    Warrensville Heights, Ohio, 44122

  • Mercy Hospital Washington

    Washington, Missouri, 63090

  • Cancer Center of Kansas - Wellington

    Wellington, Kansas, 67152

  • St. Ann's Hospital

    Westerville, Ohio, 43081

  • Cleveland Clinic - Weston

    Weston, Florida, 33331

  • Associates in Women's Health

    Wichita, Kansas, 67208

  • Cancer Center of Kansas - Medical Arts Tower

    Wichita, Kansas, 67208

  • Cancer Center of Kansas - Wichita

    Wichita, Kansas, 67214

  • Via Christi Regional Medical Center

    Wichita, Kansas, 67214

  • Wichita NCI Community Oncology Research Program

    Wichita, Kansas, 67214

  • Southeastern Medical Oncology Center-Wilson

    Wilson, North Carolina, 27893

  • Wilson Medical Center

    Wilson, North Carolina, 27893

  • Winchester Hospital

    Winchester, Massachusetts, 01890

  • Cancer Center of Kansas - Winfield

    Winfield, Kansas, 67156

  • Cleveland Clinic Cancer Center - Wooster

    Wooster, Ohio, 44691

  • Genesis Healthcare System Cancer Care Center

    Zanesville, Ohio, 43701

Other trials in United States

About this study

Official title: Fulvestrant Alone Versus Fulvestrant and Everolimus Versus Fulvestrant, Everolimus and Anastrozole: A Phase III Randomized Placebo-Controlled Trial in Postmenopausal Patients

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.

Read the 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.

Conditions
Breast Cancer
Being tested
Fulvestrant, Anastrozole, Everolimus, Placebo - Anastrozole, Placebo - Everolimus
Keywords
Metastatic breast cancer, Invasive breast carcinoma, estrogen receptor-positive breast cancer, HER2-negative breast cancer, Stage IV breast cancer, progesterone receptor-positive breast cancer
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FulvestrantDrug

    Also called Faslodex, NSC-719276

  • AnastrozoleDrug

    Also called Arimidex, NSC-719344

  • EverolimusDrug

    Also called Afinitor, Zortress, NSC-733504

  • Placebo - AnastrozoleDrug

  • Placebo - EverolimusDrug

Study groups in NCT02137837
Study groupRoleWhat they receive
Arm 1: fulvestrant + everolimus placebo + anastrozole placeboPlacebo comparatorPatients 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.
Receives: Drug: Fulvestrant; Drug: Placebo - Anastrozole; Drug: Placebo - Everolimus
Arm 2: fulvestrant + everolimus + anastrozole placeboExperimentalPatients 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.
Receives: Drug: Fulvestrant; Drug: Everolimus; Drug: Placebo - Anastrozole
Arm 3: fulvestrant + everolimus + anastrozoleExperimentalPatients 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.
Receives: Drug: Fulvestrant; Drug: Anastrozole; Drug: Everolimus

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-Free Survival (Fulvestrant vs Fulvestrant + Everolimus )

    From date of registration to date of first documentation of progression or death due to any cause. Participants last known to be alive are censored at date of last contact.

    Measured: up to 5 years

  2. Progression-free Survival (Fulvestrant Versus Fulvestrant + Everolimus + Anastrozole)

    From date of registration to date of first documentation of progression or death due to any cause. Participants last known to be alive without report of progression are censored at date of last contact.

    Measured: up to 5 years

Secondary outcomes (6)

  1. Progression Free Survival (Fulvestrant + Everolimus vs Fulvestrant + Everolimus + Anastrozole)

    From date of registration to date of first documentation of progression or death due to any cause. Participants last known to be alive without report of progression are censored at date of last contact.

    Measured: up to 5 years

  2. Overall Survival

    From date of registration to date of death due to any cause. Participants last known to be alive without report of progression are censored at date of last contact.

    Measured: up to 5 years

  3. Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs

    Adverse Events (AEs) are reported by CTCAE Version 4.0. Only adverse events that are possibly, probably or definitely related to study drug are reported.

    Measured: Duration of treatment and follow up until death or 5 years post registration

  4. Response Rate

    Proportion of participants who have confirmed or unconfirmed partial or complete response to therapy

    Measured: assessed every 12 weeks, up to 5 years

  5. Clinical Benefit Rate

    Proportion of participants who have confirmed and unconfirmed partial response, complete response or stable disease.

    Measured: assessed every 12 weeks, up to 5 years

  6. Molecular Determinants of Response in Circulating Tumor Cells: CTC-ETI

    CTC-Endocrine Therapy Index (CTC-ETI) on the CellSearch® platform. Based on enumeration of CTC/7.5 mL of whole blood, with >= 5 being elevated. (Due to limited samples collected, full analysis was not able to be performed as planned, so outcome measure reported here is number with elevated Day 1 CTC.)

    Measured: Day 1, Day 29, time of progression (Day 29 to be collected only if Day 1 CTC was elevated.)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 May 2014 (estimated)
  2. Study startMay 2014
  3. Primary completion31 Dec 2019
  4. Study completion31 Dec 2019

Why it stopped: lack of accrual

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02137837
Sponsor's protocol ID
S1222
Status last verified
Jan 2021
First submitted
12 May 2014
Last updated
28 Jan 2021
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Fulvestrant, Anastrozole and Everolimus in people with Breast Cancer, run by SWOG Cancer Research Network at 223 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 28 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 223 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (Fulvestrant vs Fulvestrant + Everolimus ) (time frame: up to 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02137837.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2021.

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