MedPath

Quality of Life in Postmenopausal Women Who Are Receiving Either Exemestane or Anastrozole With or Without Celecoxib for Stage I, Stage II, or Stage IIIA Primary Breast Cancer

Completed
Conditions
Breast Cancer
Registration Number
NCT00090974
Lead Sponsor
Eastern Cooperative Oncology Group
Brief Summary

RATIONALE: Quality-of-life assessment in postmenopausal women who are receiving hormone therapy for breast cancer may help to determine the effects of treatment on these patients and may improve the quality of life for future breast cancer patients.

PURPOSE: This clinical trial is studying quality of life of postmenopausal women who are receiving either exemestane or anastrozole with or without celecoxib for stage I, stage II, or stage IIIA primary breast cancer.

Detailed Description

OBJECTIVES:

Primary

* Compare treatment-related symptoms using the Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES) questionnaire in postmenopausal women with receptor-positive stage I, II, or IIIA primary breast cancer undergoing treatment with exemestane vs anastrozole with or without celecoxib on protocol CAN-NCIC-MA27.

Secondary

* Compare health-related quality of life using the FACT-ES questionnaire in patients treated with these regimens.

* Determine the extent to which differences in treatment-emergent symptoms affect overall quality of life in patients treated with these regimens.

OUTLINE: This is a multicenter, companion study. Patients receive treatment on CAN-NCIC-MA27.

Health-related quality of life and treatment-related symptoms are assessed using the Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES) questionnaire at baseline and at 3, 6, 12, and 24 months.

PROJECTED ACCRUAL: A total of 1,253 patients will be accrued for this study.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
Not specified
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (224)

North Colorado Medical Center

🇺🇸

Greeley, Colorado, United States

McKee Medical Center

🇺🇸

Loveland, Colorado, United States

Hematology Oncology Associates of the Quad Cities

🇺🇸

Bettendorf, Iowa, United States

Glendale Memorial Hospital Comprehensive Cancer Center

🇺🇸

Glendale, California, United States

Poudre Valley Hospital

🇺🇸

Fort Collins, Colorado, United States

Memorial Medical Center Cancer Services

🇺🇸

Modesto, California, United States

Ella Milbank Foshay Cancer Center at Jupiter Medical Center

🇺🇸

Jupiter, Florida, United States

North Bay Cancer Center

🇺🇸

Fairfield, California, United States

Northeast Georgia Medical Center

🇺🇸

Gainesville, Georgia, United States

Front Range Cancer Specialists

🇺🇸

Fort Collins, Colorado, United States

Memorial Hospital of South Bend

🇺🇸

South Bend, Indiana, United States

Fairview Ridges Hospital

🇺🇸

Burnsville, Minnesota, United States

Lawrence Memorial Hospital of Medford

🇺🇸

Medford, Massachusetts, United States

CCOP - Carle Cancer Center

🇺🇸

Urbana, Illinois, United States

CCOP - Northern Indiana CR Consortium

🇺🇸

South Bend, Indiana, United States

Mercy Memorial Hospital System

🇺🇸

Monroe, Michigan, United States

Carle Cancer Center at Carle Foundation Hospital

🇺🇸

Urbana, Illinois, United States

Rush-Copley Cancer Care Center

🇺🇸

Aurora, Illinois, United States

Regional Cancer Center at Memorial Medical Center

🇺🇸

Springfield, Illinois, United States

Delnor Community Hospital - Geneva

🇺🇸

Geneva, Illinois, United States

CCOP - Mount Sinai Medical Center

🇺🇸

Miami Beach, Florida, United States

John B. Amos Community Cancer Center

🇺🇸

Columbus, Georgia, United States

Saint Anthony Memorial Health Centers

🇺🇸

Michigan City, Indiana, United States

Mercy and Unity Cancer Center at Mercy Hospital

🇺🇸

Coon Rapids, Minnesota, United States

Freeman Cancer Institute at Freeman Health System

🇺🇸

Joplin, Missouri, United States

Cancer Center of Kansas, P.A. - El Dorado

🇺🇸

El Dorado, Kansas, United States

Miller-Dwan Medical Center

🇺🇸

Duluth, Minnesota, United States

Hubert H. Humphrey Cancer Center at North Memorial Medical Center

🇺🇸

Robbinsdale, Minnesota, United States

Hickman Cancer Center at Bixby Medical Center

🇺🇸

Adrian, Michigan, United States

Community Cancer Center of Monroe

🇺🇸

Monroe, Michigan, United States

Green Bay Oncology, Limited - Iron Mountain

🇺🇸

Iron Mountain, Michigan, United States

Missouri Baptist Cancer Center

🇺🇸

Saint Louis, Missouri, United States

St. John's Regional Medical Center

🇺🇸

Joplin, Missouri, United States

Fairview Southdale Hospital

🇺🇸

Edina, Minnesota, United States

Oncology Care Associates, P.L.L.C.

🇺🇸

Saint Joseph, Michigan, United States

Borgess Medical Center

🇺🇸

Kalamazoo, Michigan, United States

Mercy and Unity Cancer Center at Unity Hospital

🇺🇸

Fridley, Minnesota, United States

Hulston Cancer Center at Cox Medical Center South

🇺🇸

Springfield, Missouri, United States

CCOP - Metro-Minnesota

🇺🇸

Saint Louis Park, Minnesota, United States

CCOP - Cancer Research for the Ozarks

🇺🇸

Springfield, Missouri, United States

Moore Regional Community Hospital Comprehensive Cancer Center

🇺🇸

Pinehurst, North Carolina, United States

Deaconess Billings Clinic - Downtown

🇺🇸

Billings, Montana, United States

High Point Regional Hospital

🇺🇸

High Point, North Carolina, United States

St. Charles Mercy Hospital

🇺🇸

Oregon, Ohio, United States

Sletten Regional Cancer Institute

🇺🇸

Great Falls, Montana, United States

Wood County Oncology Center

🇺🇸

Bowling Green, Ohio, United States

Toledo Hospital

🇺🇸

Toledo, Ohio, United States

Adena Regional Medical Center

🇺🇸

Chillicothe, Ohio, United States

Rutherford Hospital

🇺🇸

Rutherfordton, North Carolina, United States

Blanchard Valley Medical Associates

🇺🇸

Findlay, Ohio, United States

Fremont Memorial Hospital

🇺🇸

Fremont, Ohio, United States

Lenoir Memorial Cancer Center

🇺🇸

Kinston, North Carolina, United States

St. Luke's Hospital

🇺🇸

Maumee, Ohio, United States

Wilson Medical Center

🇺🇸

Wilson, North Carolina, United States

Charles F. Kettering Memorial Hospital

🇺🇸

Kettering, Ohio, United States

Northwest Ohio Oncology Center

🇺🇸

Maumee, Ohio, United States

CCOP - Toledo Community Hospital

🇺🇸

Toledo, Ohio, United States

Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University

🇺🇸

Cleveland, Ohio, United States

MetroHealth's Cancer Care Center at MetroHealth Medical Center

🇺🇸

Cleveland, Ohio, United States

Riverside Methodist Hospital Cancer Care

🇺🇸

Columbus, Ohio, United States

Grant Riverside Cancer Services

🇺🇸

Columbus, Ohio, United States

Mount Carmel West Hospital

🇺🇸

Columbus, Ohio, United States

St. Vincent Mercy Medical Center

🇺🇸

Toledo, Ohio, United States

Medical College of Ohio Cancer Institute

🇺🇸

Toledo, Ohio, United States

Fulton County Health Center

🇺🇸

Wauseon, Ohio, United States

Cleveland Clinic - Wooster

🇺🇸

Wooster, Ohio, United States

Ruth G. McMillan Cancer Center at Greene Memorial Hospital

🇺🇸

Xenia, Ohio, United States

Toledo Surgical Specialists

🇺🇸

Toledo, Ohio, United States

Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital

🇺🇸

Westerville, Ohio, United States

Memorial Cancer Institute at Memorial Regional Hospital

🇺🇸

Hollywood, Florida, United States

Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital

🇺🇸

Fort Lauderdale, Florida, United States

Decatur Memorial Hospital Cancer Care Institute

🇺🇸

Decatur, Illinois, United States

Siouxland Regional Cancer Center

🇺🇸

Sioux City, Iowa, United States

Siouxland Hematology-Oncology Associates at June E. Nylen Cancer Center

🇺🇸

Sioux City, Iowa, United States

Cancer Center of Kansas, P.A. - Pratt

🇺🇸

Pratt, Kansas, United States

Green Bay Oncology, Limited - Escanaba

🇺🇸

Escanaba, Michigan, United States

CCOP - Kalamazoo

🇺🇸

Kalamazoo, Michigan, United States

West Michigan Cancer Center

🇺🇸

Kalamazoo, Michigan, United States

Seton Cancer Institute - Saginaw

🇺🇸

Saginaw, Michigan, United States

Cancer Care Center at St. Luke's Hospital

🇺🇸

Duluth, Minnesota, United States

Meeker County Memorial Hospital

🇺🇸

Litchfield, Minnesota, United States

Ridgeview Medical Center

🇺🇸

Waconia, Minnesota, United States

CCOP - Montana Cancer Consortium

🇺🇸

Billings, Montana, United States

Hematology-Oncology Centers of the Northern Rockies - Billings

🇺🇸

Billings, Montana, United States

Northern Rockies Radiation Oncology Center

🇺🇸

Billings, Montana, United States

Deaconess Billings Clinic Cancer Center

🇺🇸

Billings, Montana, United States

Kalispell Medical Oncology

🇺🇸

Kalispell, Montana, United States

St. Peter's Hospital

🇺🇸

Helena, Montana, United States

St. Barnabas Medical Center

🇺🇸

Livingston, New Jersey, United States

CCOP - Nevada Cancer Research Foundation

🇺🇸

Las Vegas, Nevada, United States

Wayne Memorial Hospital, Incorporated

🇺🇸

Goldsboro, North Carolina, United States

Pardee Memorial Hospital

🇺🇸

Hendersonville, North Carolina, United States

Bismarck Cancer Center

🇺🇸

Bismarck, North Dakota, United States

Cancer Care Center at Medcenter One Hospital

🇺🇸

Bismarck, North Dakota, United States

Mid Dakota Clinic, P. C.

🇺🇸

Bismarck, North Dakota, United States

Doctors Hospital at Ohio Health

🇺🇸

Columbus, Ohio, United States

Community Oncology Group - Independence

🇺🇸

Independence, Ohio, United States

Kenton Oncology, Incorporated

🇺🇸

Kenton, Ohio, United States

Lima Memorial Hospital

🇺🇸

Lima, Ohio, United States

Strecker Cancer Center at Marietta Memorial Hospital

🇺🇸

Marietta, Ohio, United States

UVMC Cancer Care Center at Upper Valley Medical Center

🇺🇸

Troy, Ohio, United States

Middletown Regional Hospital

🇺🇸

Middletown, Ohio, United States

Licking Memorial Cancer Care Program at Licking Memorial Hospital

🇺🇸

Newark, Ohio, United States

Toledo Clinic - Oregon

🇺🇸

Oregon, Ohio, United States

North Coast Cancer Care, Incorporated

🇺🇸

Sandusky, Ohio, United States

Firelands Regional Medical Center

🇺🇸

Sandusky, Ohio, United States

Community Hospital of Springfield and Clark County

🇺🇸

Springfield, Ohio, United States

Mercy Medical Center Oncology Unit

🇺🇸

Springfield, Ohio, United States

Promedica Cancer Center at Flower Hospital

🇺🇸

Sylvania, Ohio, United States

Mercy Hospital of Tiffin

🇺🇸

Tiffin, Ohio, United States

Genesis - Good Samaritan Hospital

🇺🇸

Zanesville, Ohio, United States

Legacy Mount Hood Medical Center

🇺🇸

Gresham, Oregon, United States

Providence Milwaukie Hospital

🇺🇸

Milwaukie, Oregon, United States

Legacy Meridian Park Hospital

🇺🇸

Tualatin, Oregon, United States

Bryn Mawr Hospital

🇺🇸

Bryn Mawr, Pennsylvania, United States

Paoli Memorial Hospital

🇺🇸

Paoli, Pennsylvania, United States

Joan Karnell Cancer Center at Pennsylvania Hospital

🇺🇸

Philadelphia, Pennsylvania, United States

Phoenixville Hospital

🇺🇸

Phoenixville, Pennsylvania, United States

Pottstown Memorial Regional Cancer Center

🇺🇸

Pottstown, Pennsylvania, United States

Grand View Hospital

🇺🇸

Sellersville, Pennsylvania, United States

CCOP - MainLine Health

🇺🇸

Wynnewood, Pennsylvania, United States

Lankenau Cancer Center at Lankenau Hospital

🇺🇸

Wynnewood, Pennsylvania, United States

Rose Ramer Cancer Clinic at Anderson Area Medical Center

🇺🇸

Anderson, South Carolina, United States

Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

🇺🇸

Spartanburg, South Carolina, United States

CCOP - Upstate Carolina

🇺🇸

Spartanburg, South Carolina, United States

Cascade Cancer Center at Evergreen Hospital Medical Center

🇺🇸

Kirkland, Washington, United States

Rapid City Regional Hospital

🇺🇸

Rapid City, South Dakota, United States

Olympic Medical Center

🇺🇸

Port Angeles, Washington, United States

Valley Medical Center

🇺🇸

Renton, Washington, United States

CCOP - Virginia Mason Research Center

🇺🇸

Seattle, Washington, United States

Green Bay Oncology, Limited at St. Vincent Hospital

🇺🇸

Green Bay, Wisconsin, United States

Southwest Washington Medical Center Cancer Center

🇺🇸

Vancouver, Washington, United States

St. Vincent Hospital Regional Cancer Center

🇺🇸

Green Bay, Wisconsin, United States

Green Bay Oncology, Limited at St. Mary's Hospital

🇺🇸

Green Bay, Wisconsin, United States

Green Bay Oncology, Limited - Oconto Falls

🇺🇸

Oconto Falls, Wisconsin, United States

St. Mary's Hospital Medical Center

🇺🇸

Green Bay, Wisconsin, United States

Green Bay Oncology, Limited - Sturgeon Bay

🇺🇸

Sturgeon Bay, Wisconsin, United States

Virginia Piper Cancer Institute at Abbott-Northwestern Hospital

🇺🇸

Minneapolis, Minnesota, United States

Hennepin County Medical Center - Minneapolis

🇺🇸

Minneapolis, Minnesota, United States

Cancer Center of Kansas, P.A. - Parsons

🇺🇸

Parsons, Kansas, United States

St. Alexius Medical Center

🇺🇸

Bismarck, North Dakota, United States

Cancer Center of Kansas, P.A. - Chanute

🇺🇸

Chanute, Kansas, United States

Cancer Center of Kansas, P.A. - Dodge City

🇺🇸

Dodge City, Kansas, United States

Cancer Center of Kansas, P.A. - Kingman

🇺🇸

Kingman, Kansas, United States

Cancer Center of Kansas, P.A. - Newton

🇺🇸

Newton, Kansas, United States

Cancer Center of Kansas, P.A. - Wellington

🇺🇸

Wellington, Kansas, United States

Welch Cancer Center

🇺🇸

Sheridan, Wyoming, United States

Cancer Center of Kansas, P.A. - Salina

🇺🇸

Salina, Kansas, United States

Mount Carmel Regional Cancer Center

🇺🇸

Pittsburg, Kansas, United States

Cancer Center of Kansas, P.A. - Winfield

🇺🇸

Winfield, Kansas, United States

Southwest Medical Center

🇺🇸

Liberal, Kansas, United States

St. James Community Hospital

🇺🇸

Butte, Montana, United States

Eastern Montana Cancer Center

🇺🇸

Miles City, Montana, United States

Great Falls Clinic

🇺🇸

Great Falls, Montana, United States

Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital

🇺🇸

Fairbanks, Alaska, United States

Montana Cancer Center at St. Patrick Hospital and Health Sciences Center

🇺🇸

Missoula, Montana, United States

University Medical Center of Southern Nevada

🇺🇸

Las Vegas, Nevada, United States

St. Vincent Healthcare

🇺🇸

Billings, Montana, United States

Glacier Oncology, PLLC

🇺🇸

Kalispell, Montana, United States

Community Medical Center

🇺🇸

Missoula, Montana, United States

Hunterdon Regional Cancer Center at Hunterdon Medical Center

🇺🇸

Flemington, New Jersey, United States

Montana Cancer Specialists at Montana Cancer Center

🇺🇸

Missoula, Montana, United States

Banner Good Samaritan Medical Center

🇺🇸

Phoenix, Arizona, United States

CCOP - Western Regional, Arizona

🇺🇸

Phoenix, Arizona, United States

Banner Thunderbird Medical Center

🇺🇸

Phoenix, Arizona, United States

Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center

🇺🇸

Portland, Oregon, United States

Providence Cancer Center at Providence Portland Medical Center

🇺🇸

Portland, Oregon, United States

CCOP - Columbia River Oncology Program

🇺🇸

Portland, Oregon, United States

Providence St. Vincent Medical Center

🇺🇸

Portland, Oregon, United States

Institute of Oncology at Vilnius University

🇺🇸

Portland, Oregon, United States

St. John's Regional Health Center

🇺🇸

Springfield, Missouri, United States

Park Nicollet Health Services

🇺🇸

Saint Louis Park, Minnesota, United States

CCOP - Duluth

🇺🇸

Duluth, Minnesota, United States

Regions Hospital Cancer Care Center

🇺🇸

Saint Paul, Minnesota, United States

Saint Francis Cancer Center

🇺🇸

Shakopee, Minnesota, United States

St. Joseph's Hospital

🇺🇸

Saint Paul, Minnesota, United States

St. Luke's Regional Medical Center

🇺🇸

Sioux City, Iowa, United States

Mercy Medical Center - Sioux City

🇺🇸

Sioux City, Iowa, United States

Genesis Regional Cancer Center at Genesis Medical Center

🇺🇸

Davenport, Iowa, United States

Elkhart General Hospital

🇺🇸

Elkhart, Indiana, United States

Woodwinds Health Campus

🇺🇸

Woodbury, Minnesota, United States

Saint Joseph Regional Medical Center

🇺🇸

South Bend, Indiana, United States

Center for Cancer Therapy at LaPorte Hospital and Health Services

🇺🇸

La Porte, Indiana, United States

Genesis Medical Center - West Campus

🇺🇸

Davenport, Iowa, United States

Haematology-Oncology Associates of Ohio and Michigan, P.C.

🇺🇸

Lambertville, Michigan, United States

Mercy Cancer Center at Mercy Medical Center - North Iowa

🇺🇸

Mason City, Iowa, United States

Hutchinson Area Health Care

🇺🇸

Hutchinson, Minnesota, United States

CCOP - Columbus

🇺🇸

Columbus, Ohio, United States

Internal Medicine Associates of Bozeman

🇺🇸

Bozeman, Montana, United States

Bronson Methodist Hospital

🇺🇸

Kalamazoo, Michigan, United States

CentraCare Clinic - River Campus

🇺🇸

Saint Cloud, Minnesota, United States

St. Mary's - Duluth Clinic Cancer Center

🇺🇸

Duluth, Minnesota, United States

Cleveland Clinic Taussig Cancer Center

🇺🇸

Cleveland, Ohio, United States

Grady Memorial Hospital

🇺🇸

Delaware, Ohio, United States

United Hospital

🇺🇸

Saint Paul, Minnesota, United States

CCOP - Kansas City

🇺🇸

Kansas City, Missouri, United States

Mercy Capitol Hospital

🇺🇸

Des Moines, Iowa, United States

CCOP - Iowa Oncology Research Association

🇺🇸

Des Moines, Iowa, United States

John Stoddard Cancer Center at Iowa Methodist Medical Center

🇺🇸

Des Moines, Iowa, United States

Medical Oncology and Hematology Associates at John Stoddard Cancer Center

🇺🇸

Des Moines, Iowa, United States

Medical Oncology and Hematology Associates at Mercy Cancer Center

🇺🇸

Des Moines, Iowa, United States

Mercy Cancer Center at Mercy Medical Center - Des Moines

🇺🇸

Des Moines, Iowa, United States

John Stoddard Cancer Center at Iowa Lutheran Hospital

🇺🇸

Des Moines, Iowa, United States

Associates in Womens Health, P.A. - North Review

🇺🇸

Wichita, Kansas, United States

Cancer Center of Kansas, P.A. - Medical Arts Tower

🇺🇸

Wichita, Kansas, United States

Cancer Center of Kansas, P.A. - Wichita

🇺🇸

Wichita, Kansas, United States

CCOP - Wichita

🇺🇸

Wichita, Kansas, United States

Via Christi Cancer Center at Via Christi Regional Medical Center

🇺🇸

Wichita, Kansas, United States

Albert Einstein Cancer Center at Albert Einstein College of Medicine

🇺🇸

Bronx, New York, United States

Grandview Hospital

🇺🇸

Dayton, Ohio, United States

David L. Rike Cancer Center at Miami Valley Hospital

🇺🇸

Dayton, Ohio, United States

Good Samaritan Hospital

🇺🇸

Dayton, Ohio, United States

Samaritan North Cancer Care Center

🇺🇸

Dayton, Ohio, United States

Veterans Affairs Medical Center - Dayton

🇺🇸

Dayton, Ohio, United States

CCOP - Dayton

🇺🇸

Dayton, Ohio, United States

Medical Oncology and Hematology Associates - West Des Moines

🇺🇸

West Des Moines, Iowa, United States

St. John's Hospital

🇺🇸

Maplewood, Minnesota, United States

Toledo Clinic, Incorporated - Main Clinic

🇺🇸

Toledo, Ohio, United States

Bozeman Deaconess Hospital

🇺🇸

Bozeman, Montana, United States

Joliet Oncology Hematology Associates, Limited - West

🇺🇸

Joliet, Illinois, United States

Swedish American Hospital

🇺🇸

Rockford, Illinois, United States

St. Francis Hospital and Health Centers

🇺🇸

Beech Grove, Indiana, United States

Comprehensive Cancer Center at Desert Regional Medical Center

🇺🇸

Palm Springs, California, United States

Fairfield Medical Center

🇺🇸

Lancaster, Ohio, United States

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