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

NCT ID: NCT02137837

Last Updated: 2021-01-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2019-12-31

Brief 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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

Fulvestrant

Intervention Type: DRUG

Placebo - Anastrozole

Intervention Type: DRUG

Placebo - Everolimus

Intervention Type: DRUG

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.

Group Type: EXPERIMENTAL

Fulvestrant

Intervention Type: DRUG

Everolimus

Intervention Type: DRUG

Placebo - Anastrozole

Intervention Type: DRUG

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.

Group Type: EXPERIMENTAL

Fulvestrant

Intervention Type: DRUG

Anastrozole

Intervention Type: DRUG

Everolimus

Intervention Type: DRUG

Interventions

Fulvestrant

Intervention Type: DRUG

Anastrozole

Intervention Type: DRUG

Everolimus

Intervention Type: DRUG

Placebo - Anastrozole

Intervention Type: DRUG

Placebo - Everolimus

Intervention Type: DRUG

Other Intervention Names

Faslodex; NSC-719276; Arimidex; NSC-719344; Afinitor; Zortress; NSC-733504

Eligibility Criteria

Inclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: collaborator

Novartis

INDUSTRY

Sponsor Role: collaborator

SWOG Cancer Research Network

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Halle Moore, M.D.

Role: STUDY_CHAIR

The Cleveland Clinic

Locations

Alaska Breast Care and Surgery LLC

Anchorage, Alaska, United States

Alaska Women's Cancer Care

Anchorage, Alaska, United States

Anchorage Oncology Centre

Anchorage, Alaska, United States

Katmai Oncology Group

Anchorage, Alaska, United States

Providence Alaska Medical Center

Anchorage, Alaska, United States

Virginia G. Piper Cancer Center

Scottsdale, Arizona, United States

University of Arizona Cancer Center - Orange Grove

Tucson, Arizona, United States

University of Arizona Cancer Center - North Campus

Tucson, Arizona, United States

Southern Arizona VA Health Care System

Tucson, Arizona, United States

University of Arizona Medical Center - Univ Campus

Tucson, Arizona, United States

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Providence St. Joseph Medical Ctr/Disney Family CC

Burbank, California, United States

City of Hope-Corona

Corona, California, United States

City of Hope National Medical Center

Duarte, California, United States

City of Hope Antelope Valley

Lancaster, California, United States

Bay Area Tumor Institute

Oakland, California, United States

Summit Medical Center

Oakland, California, United States

Epic Care - Oakland

Oakland, California, United States

City of Hope South Pasadena

South Pasadena, California, United States

Bridgeport Hospital

Bridgeport, Connecticut, United States

St. Francis Hospital and Medical Center

Hartford, Connecticut, United States

Yale University

New Haven, Connecticut, United States

Yale-New Haven Hospital North Haven Medical Center

North Haven, Connecticut, United States

Sacred Heart Hospital

Pensacola, Florida, United States

Cleveland Clinic - Weston

Weston, Florida, United States

South Georgia Medical Center - Pearlman Cancer Ctr

Valdosta, Georgia, United States

Oncare Hawaii Inc-POB I

Honolulu, Hawaii, United States

Oncare Hawaii, Inc - POB II

Honolulu, Hawaii, United States

Straub Clinic and Hospital

Honolulu, Hawaii, United States

University of Hawaii Cancer Center

Honolulu, Hawaii, United States

Oncare Hawaii, Inc - Kuakini

Honolulu, Hawaii, United States

Oncare Hawaii, Inc - Liliha

Honolulu, Hawaii, United States

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, United States

Wilcox Memorial Hospital and Kauai Medical Clinic

Lihue, Hawaii, United States

Oncare Hawaii, Inc - Pali Momi

‘Aiea, Hawaii, United States

Pali Momi Medical Center

‘Aiea, Hawaii, United States

St. Alphonsus Regional Medical Center

Boise, Idaho, United States

Kootenai Medical Center

Coeur d'Alene, Idaho, United States

Kootenai Cancer Center

Post Falls, Idaho, United States

Kootenai Cancer Clinic

Sandpoint, Idaho, United States

Centralia Oncology Clinic

Centralia, Illinois, United States

Cancer Care Specialists of Central Illinois

Decatur, Illinois, United States

Decatur Memorial Hospital

Decatur, Illinois, United States

Heartland Cancer Research NCORP

Decatur, Illinois, United States

Kishwaukee Community Hospital

DeKalb, Illinois, United States

Crossroads Cancer Center

Effingham, Illinois, United States

Loyola University Stritch School of Medicine

Maywood, Illinois, United States

Marjorie Weinberg Cancer Center

Melrose Park, Illinois, United States

Good Samaritan Regional Health Center

Mount Vernon, Illinois, United States

Central Illinois Hematology Oncology Center

Springfield, Illinois, United States

Springfield Clinic

Springfield, Illinois, United States

Memorial Medical Center

Springfield, Illinois, United States

Cancer Care Specialists of Illinois-Swansea

Swansea, Illinois, United States

Reid Hospital and Health Care Services

Richmond, Indiana, United States

Cancer Center of Kansas - Chanute

Chanute, Kansas, United States

Cancer Center of Kansas - Dodge City

Dodge City, Kansas, United States

Cancer Center of Kansas - El Dorado

El Dorado, Kansas, United States

Cancer Center of Kansas - Fort Scott

Fort Scott, Kansas, United States

Cancer Center of Kansas - Independence

Independence, Kansas, United States

Cancer Center of Kansas - Kingman

Kingman, Kansas, United States

Lawrence Memorial Hospital

Lawrence, Kansas, United States

Cancer Center of Kansas - Liberal

Liberal, Kansas, United States

Cancer Center of Kansas - Newton

Newton, Kansas, United States

Cancer Center of Kansas - Parsons

Parsons, Kansas, United States

Cancer Center of Kansas - Pratt

Pratt, Kansas, United States

Cancer Center of Kansas - Salina

Salina, Kansas, United States

Cancer Center of Kansas - Wellington

Wellington, Kansas, United States

Associates in Women's Health

Wichita, Kansas, United States

Cancer Center of Kansas - Medical Arts Tower

Wichita, Kansas, United States

Cancer Center of Kansas - Wichita

Wichita, Kansas, United States

Via Christi Regional Medical Center

Wichita, Kansas, United States

Wichita NCI Community Oncology Research Program

Wichita, Kansas, United States

Cancer Center of Kansas - Winfield

Winfield, Kansas, United States

De Soto Regional Medical Center

Mansfield, Louisiana, United States

University Health Conway

Monroe, Louisiana, United States

Highland Clinic

Shreveport, Louisiana, United States

Louisiana State University Health Sciences Center

Shreveport, Louisiana, United States

Sinai Hospital of Baltimore

Baltimore, Maryland, United States

Beverly Hospital

Beverly, Massachusetts, United States

Lahey Hospital and Medical Center

Burlington, Massachusetts, United States

Addison Gilbert Hospital

Gloucester, Massachusetts, United States

Winchester Hospital

Winchester, Massachusetts, United States

Michigan Cancer Research Consortium NCORP

Ann Arbor, Michigan, United States

St. Joseph Mercy Hospital

Ann Arbor, Michigan, United States

University of Michigan Medical Center

Ann Arbor, Michigan, United States

Oakwood Healthcare, Inc.

Dearborn, Michigan, United States

Wayne State University Medical Center

Detroit, Michigan, United States

St. John Hospital and Medical Center

Detroit, Michigan, United States

Genesys Hurley Cancer Institute

Flint, Michigan, United States

Hurley Medical Center

Flint, Michigan, United States

William Beaumont Hospital-Grosse Pointe

Grosse Pointe, Michigan, United States

Allegiance Health

Jackson, Michigan, United States

Sparrow Health System

Lansing, Michigan, United States

St. Mary Mercy Hospital

Livonia, Michigan, United States

MidMichigan Medical Center - Midland

Midland, Michigan, United States

St Joseph Mercy Hospital - Oakland

Pontiac, Michigan, United States

St. Joseph Mercy Port Huron

Port Huron, Michigan, United States

Beaumont Children's Hospital-Royal Oak

Royal Oak, Michigan, United States

Beaumont NCI Community Oncology Research Program

Royal Oak, Michigan, United States

St. Mary's Health System

Saginaw, Michigan, United States

Beaumont Hospital, Troy Campus

Troy, Michigan, United States

St. John Macomb Hospital

Warren, Michigan, United States

University of Mississippi Medical Center

Jackson, Mississippi, United States

Central Care Cancer Ctr-Carrie J. Babb Cancer Ctr

Bolivar, Missouri, United States

Cox Cancer Center Branson

Branson, Missouri, United States

St. Francis Medical Center

Cape Girardeau, Missouri, United States

Mercy Hospital - Joplin

Joplin, Missouri, United States

Mercy Clinic Care and Hematology - Rolla

Rolla, Missouri, United States

PCRMC Bond Clinic

Rolla, Missouri, United States

Phelps County Regional Medical Center

Rolla, Missouri, United States

Cancer Research for the Ozarks NCORP

Springfield, Missouri, United States

Mercy Hospital Springfield

Springfield, Missouri, United States

CoxHealth South Hospital

Springfield, Missouri, United States

St. Louis Cancer and Breast Institute-South City

St Louis, Missouri, United States

Christian Hospital

St Louis, Missouri, United States

Mercy Hospital St. Louis

St Louis, Missouri, United States

Mercy Hospital Washington

Washington, Missouri, United States

Montana Cancer Consortium NCORP

Billings, Montana, United States

Billings Clinic Cancer Center

Billings, Montana, United States

Bozeman Deaconess Hospital

Bozeman, Montana, United States

St. James Community Hosp and Cancer Treatment Center

Butte, Montana, United States

Benefis Healthcare West Campus

Great Falls, Montana, United States

St. Peter's Community Hospital

Helena, Montana, United States

Kalispell Regional Medical Center

Kalispell, Montana, United States

Community Medical Center

Missoula, Montana, United States

St. Patrick Hospital

Missoula, Montana, United States

CHI Health Good Samaritan Hospital

Kearney, Nebraska, United States

Southeastern Medical Oncology Center-Clinton

Clinton, North Carolina, United States

Southeastern Medical Oncology Center-Goldsboro

Goldsboro, North Carolina, United States

Wayne Memorial Hospital

Goldsboro, North Carolina, United States

Hendersonville Hematology and Oncology at Pardee

Hendersonville, North Carolina, United States

Margaret R. Pardee Memorial Hospital

Hendersonville, North Carolina, United States

Park Ridge Health

Hendersonville, North Carolina, United States

Southeastern Medical Oncology Center-Jacksonville

Jacksonville, North Carolina, United States

Southeastern Medical Oncology Center-Wilson

Wilson, North Carolina, United States

Wilson Medical Center

Wilson, North Carolina, United States

Cleveland Clinic Cancer Center - Beachwood

Beachwood, Ohio, United States

Strecker Cancer Center-Belpre

Belpre, Ohio, United States

Adena Regional Medical Center

Chillicothe, Ohio, United States

VA Medical Center - Cincinnati

Cincinnati, Ohio, United States

University of Cincinnati Medical Center

Cincinnati, Ohio, United States

Cleveland Clinic Cancer Center - Fairview Hospital

Cleveland, Ohio, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Mount Carmel East Hospital

Columbus, Ohio, United States

Columbus NCI Community Oncology Research Program

Columbus, Ohio, United States

The Mark H. Zangmeister Center

Columbus, Ohio, United States

Mount Carmel Health Center West

Columbus, Ohio, United States

Good Samaritan Hospital and Health Center

Dayton, Ohio, United States

Samaritan North Health Center

Dayton, Ohio, United States

Dayton NCI Community Oncology Research Program

Dayton, Ohio, United States

VA Medical Center - Dayton

Dayton, Ohio, United States

Wayne Hospital

Greenville, Ohio, United States

Cleveland Clinic Cancer Center - Independence

Independence, Ohio, United States

Kettering Medical Center

Kettering, Ohio, United States

Fairfield Medical Center

Lancaster, Ohio, United States

Cleveland Clinic Cancer Center - Mansfield

Mansfield, Ohio, United States

Marietta Memorial Hospital

Marietta, Ohio, United States

Hillcrest Hospital Cancer Center

Mayfield Heights, Ohio, United States

Knox Community Hospital

Mount Vernon, Ohio, United States

Licking Memorial Hospital

Newark, Ohio, United States

Southern Ohio Medical Center

Portsmouth, Ohio, United States

North Coast Cancer Care, Inc.

Sandusky, Ohio, United States

Springfield Regional Medical Center

Springfield, Ohio, United States

Springfield Regional Cancer Center

Springfield, Ohio, United States

Cleveland Clinic Strongsville Family Health Center

Strongsville, Ohio, United States

Upper Valley Medical Centers

Troy, Ohio, United States

South Pointe Hospital

Warrensville Heights, Ohio, United States

St. Ann's Hospital

Westerville, Ohio, United States

Cleveland Clinic Cancer Center - Wooster

Wooster, Ohio, United States

Genesis Healthcare System Cancer Care Center

Zanesville, Ohio, United States

St. Charles Health System

Bend, Oregon, United States

Clackamas Radiation Oncology Center

Clackamas, Oregon, United States

Providence Oncology and Hematology Care Southeast

Clackamas, Oregon, United States

Providence Newberg Medical Center

Newberg, Oregon, United States

Providence Willamette Falls Medical Center

Oregon City, Oregon, United States

Providence Portland Medical Center

Portland, Oregon, United States

Providence St. Vincent Medical Center

Portland, Oregon, United States

McLeod Regional Medical Center

Florence, South Carolina, United States

Gibbs Cancer Center-Gaffney

Gaffney, South Carolina, United States

Gibbs Cancer Center-Pelham

Greer, South Carolina, United States

Spartanburg Medical Cancer

Spartanburg, South Carolina, United States

MGC Hematology Oncology-Union

Union, South Carolina, United States

Wellmont Bristol Regional Medical Center

Bristol, Tennessee, United States

Wellmont Medical Associates Oncology and Hematology

Bristol, Tennessee, United States

Wellmont Medical Assoc Onc and Hem-Johnson City

Johnson City, Tennessee, United States

Holston Valley Hospital and Medical Center

Kingsport, Tennessee, United States

Wellmont Medical Assoc Onc and Hem-Kingsport

Kingsport, Tennessee, United States

Thompson Cancer Survival Center

Knoxville, Tennessee, United States

Don and Sybil Harrington Cancer Center

Amarillo, Texas, United States

University of Utah Medical Center

Salt Lake City, Utah, United States

Southwest Virginia Cancer Center

Norton, Virginia, United States

Island Hospital

Anacortes, Washington, United States

Auburn Regional Medical Center

Auburn, Washington, United States

Virginia Mason Bainbridge Island Medical Center

Bainbridge Island, Washington, United States

Overlake Hospital Medical Center

Bellevue, Washington, United States

Swedish Cancer Inst-Eastside Oncology Hematoly

Bellevue, Washington, United States

PeaceHealth St. Joseph Medical Center

Bellingham, Washington, United States

Swedish Medical Center - Edmonds

Edmonds, Washington, United States

Virginia Mason Federal Way Medical Center

Federal Way, Washington, United States

Tacoma/Valley Radiation Oncology Ctrs-Gig Harbor

Gig Harbor, Washington, United States

MultiCare Gig Harbor Medical Park

Gig Harbor, Washington, United States

Swedish Cancer Institute-Issaquah

Issaquah, Washington, United States

PeaceHealth St. John Medical Center

Longview, Washington, United States

Virginia Mason Lynnwood Medical Center

Lynnwood, Washington, United States

MultiCare Good Samaritan Hospital

Puyallup, Washington, United States

Tacoma/Valley Radiation Oncology Ctrs-Puyallup

Puyallup, Washington, United States

Virginia Mason Medical Center

Seattle, Washington, United States

Minor and James Medical, PLLC

Seattle, Washington, United States

Pacific Cancer Research Consortium NCORP

Seattle, Washington, United States

Pacific Medical Center - First Hill

Seattle, Washington, United States

Swedish Medical Center

Seattle, Washington, United States

Swedish Medical Center - Ballard Campus

Seattle, Washington, United States

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Group Health Cooperative-Seattle

Seattle, Washington, United States

Tacoma/Valley Radiation Oncology Ctrs-Jackson Hill

Tacoma, Washington, United States

Mary Bridge Children's Hospital and Health Center

Tacoma, Washington, United States

MultiCare Tacoma General Hospital

Tacoma, Washington, United States

Northwest NCI Community Oncology Research Program

Tacoma, Washington, United States

Tacoma/Valley Radiation Oncology Ctrs-Saint Joe's

Tacoma, Washington, United States

Multicare Health System

Tacoma, Washington, United States

PeaceHealth Southwest Medical Center

Vancouver, Washington, United States

Billings Clinic-Cody

Cody, Wyoming, United States

Welch Cancer Center - Sheridan Memorial Hospital

Sheridan, Wyoming, United States

Countries

United States

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

S1222

Identifier Type: -

Identifier Source: org_study_id