Know Cancer

or
forgot password

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
Open (Enrolling)
Female
Breast Cancer

Thank you

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