Quality Of Life Companion Study For JMA27 (NCIC-MA.27): A Randomized Phase III Trial Of Exemestane Versus Anastrozole With Or Without Celecoxib In Postmenopausal Women With Receptor Positive Primary Breast Cancer
N/A
N/A
N/A
N/A
N/A
Open (Enrolling)
Female
Breast Cancer
Female
Breast Cancer
Trial Information
Quality Of Life Companion Study For JMA27 (NCIC-MA.27): A Randomized Phase III Trial Of Exemestane Versus Anastrozole With Or Without Celecoxib In Postmenopausal Women With Receptor Positive Primary Breast Cancer
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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed invasive breast cancer
- pT1-3; pNX, pN0-2 or pN3*; M0 NOTE: *Only when the sole basis for this
classification is the presence of 10 or more involved axillary lymph nodes
- Registered on protocol CAN-NCIC-MA27 within the past week
- Hormone receptor status:
- Estrogen receptor- and/or progesterone receptor-positive by immunohistochemistry
or tumor receptor content ≥ 10 fmol/mg protein
- At least 1 tumor must be receptor-positive in patients with bilateral breast
cancer
PATIENT CHARACTERISTICS:
Age
- Postmenopausal
Performance status
- ECOG 0-2
Sex
- Female
Menopausal status
- Postmenopausal
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
Other
- Able to read, understand, and complete quality of life questionnaires
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Type of Study:
Observational
Study Design:
N/A
Principal Investigator
Lynne Wagner, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Robert H. Lurie Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000380937
NCT ID:
NCT00090974
Start Date:
December 2004
Completion Date:
Related Keywords:
- Breast Cancer
- stage I breast cancer
- stage II breast cancer
- stage IIIA breast cancer
- Breast Neoplasms
Name | Location |
|---|---|
| CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
| CCOP - Wichita | Wichita, Kansas 67214-3882 |
| CCOP - Kansas City | Kansas City, Missouri 64131 |
| CCOP - Mount Sinai Medical Center | Miami Beach, Florida 33140 |
| CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
| CCOP - Iowa Oncology Research Association | Des Moines, Iowa 50309-1016 |
| CCOP - Kalamazoo | Kalamazoo, Michigan 49007-3731 |
| CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
| Rush-Copley Cancer Care Center | Aurora, Illinois 60507 |
| Carle Cancer Center at Carle Foundation Hospital | Urbana, Illinois 61801 |
| Saint Anthony Memorial Health Centers | Michigan City, Indiana 46360 |
| Mercy Medical Center - Sioux City | Sioux City, Iowa 51104 |
| St. Luke's Regional Medical Center | Sioux City, Iowa 51104 |
| Bronson Methodist Hospital | Kalamazoo, Michigan 49007 |
| West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
| Borgess Medical Center | Kalamazooaa, Michigan 49001 |
| Seton Cancer Institute - Saginaw | Saginaw, Michigan 48601 |
| Fairview Ridges Hospital | Burnsville, Minnesota 55337 |
| Mercy and Unity Cancer Center at Mercy Hospital | Coon Rapids, Minnesota 55433 |
| CCOP - Duluth | Duluth, Minnesota 55805 |
| Fairview Southdale Hospital | Edina, Minnesota 55435 |
| Mercy and Unity Cancer Center at Unity Hospital | Fridley, Minnesota 55432 |
| Hutchinson Area Health Care | Hutchinson, Minnesota 55350 |
| Meeker County Memorial Hospital | Lichfield, Minnesota 55355 |
| Hennepin County Medical Center - Minneapolis | Minneapolis, Minnesota 55415 |
| Regions Hospital Cancer Care Center | St. Paul, Minnesota 55101 |
| United Hospital | St. Paul, Minnesota 55102 |
| Ridgeview Medical Center | Waconia, Minnesota 55387 |
| Rapid City Regional Hospital | Rapid City, South Dakota 57709 |
| Memorial Hospital of South Bend | South Bend, Indiana 46601 |
| CCOP - Cancer Research for the Ozarks | Springfield, Missouri 65807 |
| CCOP - Montana Cancer Consortium | Billings, Montana 59101 |
| CCOP - Columbus | Columbus, Ohio 43206 |
| Veterans Affairs Medical Center - Dayton | Dayton, Ohio 45428 |
| CCOP - Dayton | Kettering, Ohio 45429 |
| Grand View Hospital | Sellersville, Pennsylvania 18960 |
| CCOP - MainLine Health | Wynnewood, Pennsylvania 19096 |
| CCOP - Western Regional, Arizona | Phoenix, Arizona 85006-2726 |
| CCOP - Northern Indiana CR Consortium | South Bend, Indiana 46601 |
| Saint Joseph Regional Medical Center | South Bend, Indiana 46617 |
| MetroHealth's Cancer Care Center at MetroHealth Medical Center | Cleveland, Ohio 44106 |
| CCOP - Columbia River Oncology Program | Portland, Oregon 97225 |
| St. Barnabas Medical Center | Livingston, New Jersey 07039 |
| Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
| CCOP - Virginia Mason Research Center | Seattle, Washington 98101 |
| John Stoddard Cancer Center at Iowa Methodist Medical Center | Des Moines, Iowa 50309 |
| St. Vincent Mercy Medical Center | Toledo, Ohio 43608 |
| Great Falls Clinic | Great Falls, Montana 59405 |
| Hulston Cancer Center at Cox Medical Center South | Springfield, Missouri 65807 |
| St. John's Regional Health Center | Springfield, Missouri 65804 |
| Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University | Cleveland, Ohio 44106 |
| CCOP - Toledo Community Hospital | Toledo, Ohio 43623-3456 |
| Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita, Kansas 67214 |
| Albert Einstein Cancer Center at Albert Einstein College of Medicine | Bronx, New York 10461 |
| Toledo Hospital | Toledo, Ohio 43606 |
| St. Vincent Hospital Regional Cancer Center | Green Bay, Wisconsin 54307-3508 |
| St. Mary's - Duluth Clinic Cancer Center | Duluth, Minnesota 55805 |
| Green Bay Oncology, Limited - Escanaba | Escanaba, Michigan 49431 |
| Hunterdon Regional Cancer Center at Hunterdon Medical Center | Flemington, New Jersey 08822 |
| Green Bay Oncology, Limited at St. Mary's Hospital | Green Bay, Wisconsin 54303 |
| Green Bay Oncology, Limited - Oconto Falls | Oconto Falls, Wisconsin 54154 |
| Green Bay Oncology, Limited - Sturgeon Bay | Sturgeon Bay, Wisconsin 54235 |
| Hematology Oncology Associates of the Quad Cities | Bettendorf, Iowa 52722 |
| Banner Good Samaritan Medical Center | Phoenix, Arizona 85006 |
| Banner Thunderbird Medical Center | Phoenix, Arizona 85306 |
| North Colorado Medical Center | Greeley, Colorado 80631 |
| McKee Medical Center | Loveland, Colorado 80539 |
| Siouxland Regional Cancer Center | Sioux City, Iowa 51101-1733 |
| Cancer Center of Kansas, P.A. - El Dorado | El Dorado, Kansas 67042 |
| Southwest Medical Center | Liberal, Kansas 67901 |
| Cancer Center of Kansas, P.A. - Parsons | Parsons, Kansas 67357 |
| Cancer Center of Kansas, P.A. - Wichita | Wichita, Kansas 67214 |
| Northern Rockies Radiation Oncology Center | Billings, Montana 59101 |
| Hematology-Oncology Centers of the Northern Rockies - Billings | Billings, Montana 59101 |
| St. Vincent Healthcare | Billings, Montana 59101 |
| Deaconess Billings Clinic - Downtown | Billings, Montana 59101 |
| Deaconess Billings Clinic Cancer Center | Billings, Montana 59107 |
| Internal Medicine Associates of Bozeman | Bozeman, Montana 59715 |
| Bozeman Deaconess Hospital | Bozeman, Montana 59715 |
| St. James Community Hospital | Butte, Montana 59701 |
| Sletten Regional Cancer Institute | Great Falls, Montana 59405 |
| St. Peter's Hospital | Helena, Montana 59601 |
| Kalispell Medical Oncology | Kalispell, Montana 59901 |
| Glacier Oncology, PLLC | Kalispell, Montana 59901 |
| Eastern Montana Cancer Center | Miles City, Montana 59301 |
| Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | Missoula, Montana 59802 |
| Montana Cancer Specialists at Montana Cancer Center | Missoula, Montana 59802 |
| Community Medical Center | Missoula, Montana 59801 |
| Wayne Memorial Hospital, Incorporated | Goldsboro, North Carolina 27534 |
| Adena Regional Medical Center | Chillicothe, Ohio 54601 |
| Doctors Hospital at Ohio Health | Columbus, Ohio 43228 |
| Riverside Methodist Hospital Cancer Care | Columbus, Ohio 43214 |
| Grant Riverside Cancer Services | Columbus, Ohio 43215 |
| Mount Carmel West Hospital | Columbus, Ohio 43222 |
| Grady Memorial Hospital | Delaware, Ohio 43015 |
| Fairfield Medical Center | Lancaster, Ohio 43130 |
| Strecker Cancer Center at Marietta Memorial Hospital | Marietta, Ohio 45750 |
| Licking Memorial Cancer Care Program at Licking Memorial Hospital | Newark, Ohio 43055 |
| Community Hospital of Springfield and Clark County | Springfield, Ohio 45505 |
| Mercy Medical Center Oncology Unit | Springfield, Ohio 45504 |
| Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital | Westerville, Ohio 43081 |
| Genesis - Good Samaritan Hospital | Zanesville, Ohio 43701 |
| Welch Cancer Center | Sheridan, Wyoming 82801 |
| Memorial Cancer Institute at Memorial Regional Hospital | Hollywood, Florida 33021 |
| Lenoir Memorial Cancer Center | Kinston, North Carolina 28503-1678 |
| CCOP - Nevada Cancer Research Foundation | Las Vegas, Nevada 89109-2306 |
| Decatur Memorial Hospital Cancer Care Institute | Decatur, Illinois 62526 |
| Paoli Memorial Hospital | Paoli, Pennsylvania 19301-1792 |
| Elkhart General Hospital | Elkhart, Indiana 46515 |
| Front Range Cancer Specialists | Fort Collins, Colorado 80528 |
| University Medical Center of Southern Nevada | Las Vegas, Nevada 89102 |
| Joan Karnell Cancer Center at Pennsylvania Hospital | Philadelphia, Pennsylvania 19107 |
| North Bay Cancer Center | Fairfield, California 94533 |
| Memorial Medical Center Cancer Services | Modesto, California 95355 |
| Poudre Valley Hospital | Fort Collins, Colorado 80524 |
| Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital | Fort Lauderdale, Florida 33308 |
| Ella Milbank Foshay Cancer Center at Jupiter Medical Center | Jupiter, Florida 33458 |
| Center for Cancer Therapy at LaPorte Hospital and Health Services | La Porte, Indiana 46350 |
| Genesis Medical Center - West Campus | Davenport, Iowa 52804 |
| Genesis Regional Cancer Center at Genesis Medical Center | Davenport, Iowa 52803 |
| John Stoddard Cancer Center at Iowa Lutheran Hospital | Des Moines, Iowa 50316-2301 |
| Mercy Capitol Hospital | Des Moines, Iowa 50307 |
| Medical Oncology and Hematology Associates at John Stoddard Cancer Center | Des Moines, Iowa 50309 |
| Medical Oncology and Hematology Associates at Mercy Cancer Center | Des Moines, Iowa 50314 |
| Mercy Cancer Center at Mercy Medical Center - Des Moines | Des Moines, Iowa 50314 |
| Medical Oncology and Hematology Associates - West Des Moines | West Des Moines, Iowa 50266 |
| Cancer Center of Kansas, P.A. - Chanute | Chanute, Kansas 66720 |
| Cancer Center of Kansas, P.A. - Kingman | Kingman, Kansas 67068 |
| Cancer Center of Kansas, P.A. - Newton | Newton, Kansas 67114 |
| Cancer Center of Kansas, P.A. - Pratt | Pratt, Kansas 67124 |
| Cancer Center of Kansas, P.A. - Salina | Salina, Kansas 67042 |
| Cancer Center of Kansas, P.A. - Wellington | Wellington, Kansas 67152 |
| Cancer Center of Kansas, P.A. - Medical Arts Tower | Wichita, Kansas 67208 |
| Associates in Womens Health, P.A. - North Review | Wichita, Kansas 67203 |
| Cancer Center of Kansas, P.A. - Winfield | Winfield, Kansas 67156 |
| Hickman Cancer Center at Bixby Medical Center | Adrian, Michigan 49221 |
| Green Bay Oncology, Limited - Iron Mountain | Iron Mountain, Michigan 49801 |
| Haematology-Oncology Associates of Ohio and Michigan, P.C. | Lambertville, Michigan 48144 |
| Community Cancer Center of Monroe | Monroe, Michigan 48162 |
| Mercy Memorial Hospital System | Monroe, Michigan 48162 |
| Virginia Piper Cancer Institute at Abbott-Northwestern Hospital | Minneapolis, Minnesota 55407 |
| Hubert H. Humphrey Cancer Center at North Memorial Medical Center | Robbinsdale, Minnesota 55422-2900 |
| CentraCare Clinic - River Campus | St. Cloud, Minnesota 56303 |
| Park Nicollet Health Services | St. Louis Park, Minnesota 55416 |
| Wilson Medical Center | Wilson, North Carolina 27893-3428 |
| Cancer Care Center at Medcenter One Hospital | Bismarck, North Dakota 58501 |
| Bismarck Cancer Center | Bismarck, North Dakota 58501 |
| St. Alexius Medical Center | Bismarck, North Dakota 58502 |
| Mid Dakota Clinic, P. C. | Bismarck, North Dakota 58501 |
| Wood County Oncology Center | Bowling Green, Ohio 43402 |
| Samaritan North Cancer Care Center | Dayton, Ohio 45415 |
| Grandview Hospital | Dayton, Ohio 45405 |
| David L. Rike Cancer Center at Miami Valley Hospital | Dayton, Ohio 45409 |
| Good Samaritan Hospital | Dayton, Ohio 45406 |
| Blanchard Valley Medical Associates | Findlay, Ohio 45840 |
| Fremont Memorial Hospital | Fremont, Ohio 43420 |
| Kenton Oncology, Incorporated | Kenton, Ohio 43326 |
| Charles F. Kettering Memorial Hospital | Kettering, Ohio 45429 |
| Lima Memorial Hospital | Lima, Ohio 45804 |
| St. Luke's Hospital | Maumee, Ohio 43537 |
| Northwest Ohio Oncology Center | Maumee, Ohio 43537 |
| Middletown Regional Hospital | Middletown, Ohio 45044 |
| Toledo Clinic - Oregon | Oregon, Ohio 43616 |
| St. Charles Mercy Hospital | Oregon, Ohio 43616 |
| North Coast Cancer Care, Incorporated | Sandusky, Ohio 44870 |
| Firelands Regional Medical Center | Sandusky, Ohio 44870 |
| Promedica Cancer Center at Flower Hospital | Sylvania, Ohio 43560 |
| Mercy Hospital of Tiffin | Tiffin, Ohio 44883 |
| Toledo Clinic, Incorporated - Main Clinic | Toledo, Ohio 43623 |
| Toledo Surgical Specialists | Toledo, Ohio 43623 |
| UVMC Cancer Care Center at Upper Valley Medical Center | Troy, Ohio 45373-1300 |
| Fulton County Health Center | Wauseon, Ohio 43567 |
| Cleveland Clinic - Wooster | Wooster, Ohio 44691 |
| Ruth G. McMillan Cancer Center at Greene Memorial Hospital | Xenia, Ohio 45385 |
| Legacy Mount Hood Medical Center | Gresham, Oregon 97030 |
| Providence Milwaukie Hospital | Milwaukie, Oregon 97222 |
| Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center | Portland, Oregon 97210 |
| Providence Cancer Center at Providence Portland Medical Center | Portland, Oregon 97213-2967 |
| Providence St. Vincent Medical Center | Portland, Oregon 97225 |
| Legacy Meridian Park Hospital | Tualatin, Oregon 97062 |
| Bryn Mawr Hospital | Bryn Mawr, Pennsylvania 19010 |
| Lankenau Cancer Center at Lankenau Hospital | Wynnewood, Pennsylvania 19096 |
| Southwest Washington Medical Center Cancer Center | Vancouver, Washington 98668 |
| Green Bay Oncology, Limited at St. Vincent Hospital | Green Bay, Wisconsin 54301-3526 |
| Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital | Fairbanks, Alaska 99701 |
| Joliet Oncology Hematology Associates, Limited - West | Joliet, Illinois 60435 |
| Community Oncology Group - Independence | Independence, Ohio 44131 |
| Rose Ramer Cancer Clinic at Anderson Area Medical Center | Anderson, South Carolina 29621 |
| Cascade Cancer Center at Evergreen Hospital Medical Center | Kirkland, Washington 98034-3013 |
| Olympic Medical Center | Port Angeles, Washington 98362 |
| Valley Medical Center | Renton, Washington 98055 |
| Miller-Dwan Medical Center | Duluth, Minnesota 55805 |
| St. John's Hospital | Maplewood, Minnesota 55109 |
| Pottstown Memorial Regional Cancer Center | Pottstown, Pennsylvania 19464 |
| Northeast Georgia Medical Center | Gainesville, Georgia 30501 |
| Swedish American Hospital | Rockford, Illinois 61104 |
| St. Francis Hospital and Health Centers | Beech Grove, Indiana 46107 |
| Mercy Cancer Center at Mercy Medical Center - North Iowa | Mason City, Iowa 50401 |
| Oncology Care Associates, P.L.L.C. | Saint Joseph, Michigan 49085 |
| Cancer Care Center at St. Luke's Hospital | Duluth, Minnesota 55805 |
| Saint Francis Cancer Center | Shakopee, Minnesota 55379 |
| St. Joseph's Hospital | St Paul, Minnesota 55102 |
| Missouri Baptist Cancer Center | St. Louis, Missouri 63131 |
| Medical College of Ohio Cancer Institute | Toledo, Ohio 43614 |
| Institute of Oncology at Vilnius University | Portland, Oregon 97227 |
| St. Mary's Hospital Medical Center | Green Bay, Wisconsin 54303 |
| Regional Cancer Center at Memorial Medical Center | Springfield, Illinois 62781-0001 |
| Pardee Memorial Hospital | Hendersonville, North Carolina 28791 |
| Moore Regional Community Hospital Comprehensive Cancer Center | Pinehurst, North Carolina 28374 |
| Rutherford Hospital | Rutherfordton, North Carolina 28139 |
| Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg, South Carolina 29303 |
| Glendale Memorial Hospital Comprehensive Cancer Center | Glendale, California 91204 |
| St. John's Regional Medical Center | Joplin, Missouri 64804 |
| Freeman Cancer Institute at Freeman Health System | Joplin, Missouri 64803-2644 |
| Comprehensive Cancer Center at Desert Regional Medical Center | Palm Springs, California 92262 |
| Woodwinds Health Campus | Woodbury, Minnesota 55125 |
| Cancer Center of Kansas, P.A. - Dodge City | Dodge City, Kansas 67801 |
| John B. Amos Community Cancer Center | Columbus, Georgia 31902 |
| Lawrence Memorial Hospital of Medford | Medford, Massachusetts 02155 |
| Siouxland Hematology-Oncology Associates at June E. Nylen Cancer Center | Sioux City, Iowa 51101 |
| High Point Regional Hospital | High Point, North Carolina 27261 |
| Delnor Community Hospital - Geneva | Geneva, Illinois 60134 |
| Mount Carmel Regional Cancer Center | Pittsburg, Kansas 66762 |
| Phoenixville Hospital | Phoenixville, Pennsylvania 19460 |
