CClinicalTrials.gg
CompletedNCT00090974Updated Jun 15, 2023

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

An observational study in Breast Cancer, sponsored by Eastern Cooperative Oncology Group. Completed at 224 sites in United States. Open to female participants aged 0 Years to 120 Years. Per ClinicalTrials.gov, last updated 2023-06-15.

Sponsored by Eastern Cooperative Oncology Group · Observational

Study type
Observational
Ages
0 Years to 120 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Breast Cancer

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Keywords

  • stage I breast cancer
  • stage II breast cancer
  • stage IIIA breast cancer
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In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

Browse Breast Neoplasms studies →

Lead sponsor

Eastern Cooperative Oncology Group is the lead sponsor of 173 studies on the registry; 7 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 5 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
0 Years to 120 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Eligibility 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
05

Study design

Patient registry
No

Interventions

  • Procedurequality-of-life assessment
06

Study locations

224 sites
  • Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital
    Fairbanks, Alaska 99701, United States
  • Banner Good Samaritan Medical Center
    Phoenix, Arizona 85006, United States
  • CCOP - Western Regional, Arizona
    Phoenix, Arizona 85006, United States
  • Banner Thunderbird Medical Center
    Phoenix, Arizona 85306, United States
  • North Bay Cancer Center
    Fairfield, California 94533, United States
  • Glendale Memorial Hospital Comprehensive Cancer Center
    Glendale, California 91204, United States
  • Memorial Medical Center Cancer Services
    Modesto, California 95355, United States
  • Comprehensive Cancer Center at Desert Regional Medical Center
    Palm Springs, California 92262, United States
  • Front Range Cancer Specialists
    Fort Collins, Colorado 80524, United States
  • Poudre Valley Hospital
    Fort Collins, Colorado 80524, United States
  • North Colorado Medical Center
    Greeley, Colorado 80631, United States
  • McKee Medical Center
    Loveland, Colorado 80539, United States
  • Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
    Fort Lauderdale, Florida 33308, United States
  • Memorial Cancer Institute at Memorial Regional Hospital
    Hollywood, Florida 33021, United States
  • Ella Milbank Foshay Cancer Center at Jupiter Medical Center
    Jupiter, Florida 33458, United States
  • CCOP - Mount Sinai Medical Center
    Miami Beach, Florida 33140, United States
  • John B. Amos Community Cancer Center
    Columbus, Georgia 31902, United States
  • Northeast Georgia Medical Center
    Gainesville, Georgia 30501, United States
  • Rush-Copley Cancer Care Center
    Aurora, Illinois 60507, United States
  • Decatur Memorial Hospital Cancer Care Institute
    Decatur, Illinois 62526, United States
  • Delnor Community Hospital - Geneva
    Geneva, Illinois 60134, United States
  • Joliet Oncology Hematology Associates, Limited - West
    Joliet, Illinois 60435, United States
  • Swedish American Hospital
    Rockford, Illinois 61104, United States
  • Regional Cancer Center at Memorial Medical Center
    Springfield, Illinois 62781-0001, United States
  • Carle Cancer Center at Carle Foundation Hospital
    Urbana, Illinois 61801, United States
  • CCOP - Carle Cancer Center
    Urbana, Illinois 61801, United States
  • St. Francis Hospital and Health Centers
    Beech Grove, Indiana 46107, United States
  • Elkhart General Hospital
    Elkhart, Indiana 46515, United States
  • Center for Cancer Therapy at LaPorte Hospital and Health Services
    La Porte, Indiana 46350, United States
  • Saint Anthony Memorial Health Centers
    Michigan City, Indiana 46360, United States
  • CCOP - Northern Indiana CR Consortium
    South Bend, Indiana 46601, United States
  • Memorial Hospital of South Bend
    South Bend, Indiana 46601, United States
  • Saint Joseph Regional Medical Center
    South Bend, Indiana 46617, United States
  • Hematology Oncology Associates of the Quad Cities
    Bettendorf, Iowa 52722, United States
  • Genesis Regional Cancer Center at Genesis Medical Center
    Davenport, Iowa 52803, United States
  • Genesis Medical Center - West Campus
    Davenport, Iowa 52804, United States
  • Mercy Capitol Hospital
    Des Moines, Iowa 50307, United States
  • CCOP - Iowa Oncology Research Association
    Des Moines, Iowa 50309, United States
  • John Stoddard Cancer Center at Iowa Methodist Medical Center
    Des Moines, Iowa 50309, United States
  • Medical Oncology and Hematology Associates at John Stoddard Cancer Center
    Des Moines, Iowa 50309, United States
  • Medical Oncology and Hematology Associates at Mercy Cancer Center
    Des Moines, Iowa 50314, United States
  • Mercy Cancer Center at Mercy Medical Center - Des Moines
    Des Moines, Iowa 50314, United States
  • John Stoddard Cancer Center at Iowa Lutheran Hospital
    Des Moines, Iowa 50316, United States
  • Mercy Cancer Center at Mercy Medical Center - North Iowa
    Mason City, Iowa 50401, United States
  • Siouxland Regional Cancer Center
    Sioux City, Iowa 51101-1733, United States
  • Siouxland Hematology-Oncology Associates at June E. Nylen Cancer Center
    Sioux City, Iowa 51101, United States
  • Mercy Medical Center - Sioux City
    Sioux City, Iowa 51104, United States
  • St. Luke's Regional Medical Center
    Sioux City, Iowa 51104, United States
  • Medical Oncology and Hematology Associates - West Des Moines
    West Des Moines, Iowa 50266, United States
  • Cancer Center of Kansas, P.A. - Chanute
    Chanute, Kansas 66720, United States
  • Cancer Center of Kansas, P.A. - Dodge City
    Dodge City, Kansas 67801, United States
  • Cancer Center of Kansas, P.A. - El Dorado
    El Dorado, Kansas 67042, United States
  • Cancer Center of Kansas, P.A. - Kingman
    Kingman, Kansas 67068, United States
  • Southwest Medical Center
    Liberal, Kansas 67901, United States
  • Cancer Center of Kansas, P.A. - Newton
    Newton, Kansas 67114, United States
  • Cancer Center of Kansas, P.A. - Parsons
    Parsons, Kansas 67357, United States
  • Mount Carmel Regional Cancer Center
    Pittsburg, Kansas 66762, United States
  • Cancer Center of Kansas, P.A. - Pratt
    Pratt, Kansas 67124, United States
  • Cancer Center of Kansas, P.A. - Salina
    Salina, Kansas 67042, United States
  • Cancer Center of Kansas, P.A. - Wellington
    Wellington, Kansas 67152, United States
  • Associates in Womens Health, P.A. - North Review
    Wichita, Kansas 67203, United States
  • Cancer Center of Kansas, P.A. - Medical Arts Tower
    Wichita, Kansas 67208, United States
  • Cancer Center of Kansas, P.A. - Wichita
    Wichita, Kansas 67214, United States
  • CCOP - Wichita
    Wichita, Kansas 67214, United States
  • Via Christi Cancer Center at Via Christi Regional Medical Center
    Wichita, Kansas 67214, United States
  • Cancer Center of Kansas, P.A. - Winfield
    Winfield, Kansas 67156, United States
  • Lawrence Memorial Hospital of Medford
    Medford, Massachusetts 02155, United States
  • Hickman Cancer Center at Bixby Medical Center
    Adrian, Michigan 49221, United States
  • Green Bay Oncology, Limited - Escanaba
    Escanaba, Michigan 49431, United States
  • Green Bay Oncology, Limited - Iron Mountain
    Iron Mountain, Michigan 49801, United States
  • Borgess Medical Center
    Kalamazoo, Michigan 49001, United States
  • CCOP - Kalamazoo
    Kalamazoo, Michigan 49001, United States
  • Bronson Methodist Hospital
    Kalamazoo, Michigan 49007, United States
  • West Michigan Cancer Center
    Kalamazoo, Michigan 49007, United States
  • Haematology-Oncology Associates of Ohio and Michigan, P.C.
    Lambertville, Michigan 48144, United States
  • Community Cancer Center of Monroe
    Monroe, Michigan 48162, United States
  • Mercy Memorial Hospital System
    Monroe, Michigan 48162, United States
  • Seton Cancer Institute - Saginaw
    Saginaw, Michigan 48601, United States
  • Oncology Care Associates, P.L.L.C.
    Saint Joseph, Michigan 49085, United States
  • Fairview Ridges Hospital
    Burnsville, Minnesota 55337, United States
  • Mercy and Unity Cancer Center at Mercy Hospital
    Coon Rapids, Minnesota 55433, United States
  • Cancer Care Center at St. Luke's Hospital
    Duluth, Minnesota 55805, United States
  • CCOP - Duluth
    Duluth, Minnesota 55805, United States
  • Miller-Dwan Medical Center
    Duluth, Minnesota 55805, United States
  • St. Mary's - Duluth Clinic Cancer Center
    Duluth, Minnesota 55805, United States
  • Fairview Southdale Hospital
    Edina, Minnesota 55435, United States
  • Mercy and Unity Cancer Center at Unity Hospital
    Fridley, Minnesota 55432, United States
  • Hutchinson Area Health Care
    Hutchinson, Minnesota 55350, United States
  • Meeker County Memorial Hospital
    Litchfield, Minnesota 55355, United States
  • St. John's Hospital
    Maplewood, Minnesota 55109, United States
  • Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
    Minneapolis, Minnesota 55407, United States
  • Hennepin County Medical Center - Minneapolis
    Minneapolis, Minnesota 55415, United States
  • Hubert H. Humphrey Cancer Center at North Memorial Medical Center
    Robbinsdale, Minnesota 55422, United States
  • CentraCare Clinic - River Campus
    Saint Cloud, Minnesota 56303, United States
  • CCOP - Metro-Minnesota
    Saint Louis Park, Minnesota 55416, United States
  • Park Nicollet Health Services
    Saint Louis Park, Minnesota 55416, United States
  • Regions Hospital Cancer Care Center
    Saint Paul, Minnesota 55101, United States
  • St. Joseph's Hospital
    Saint Paul, Minnesota 55102, United States
  • United Hospital
    Saint Paul, Minnesota 55102, United States
  • Saint Francis Cancer Center
    Shakopee, Minnesota 55379, United States

Showing the first 100 of 224 sites.

07

References and documents

Publications

  • Solomon SD, Wittes J, Finn PV, Fowler R, Viner J, Bertagnolli MM, Arber N, Levin B, Meinert CL, Martin B, Pater JL, Goss PE, Lance P, Obara S, Chew EY, Kim J, Arndt G, Hawk E; Cross Trial Safety Assessment Group. Cardiovascular risk of celecoxib in 6 randomized placebo-controlled trials: the cross trial safety analysis. Circulation. 2008 Apr 22;117(16):2104-13. doi: 10.1161/CIRCULATIONAHA.108.764530. Epub 2008 Mar 31. PubMed 18378608 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 15, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00090974
Lead sponsor
Eastern Cooperative Oncology Group
Collaborators
National Cancer Institute (NCI), NCIC Clinical Trials Group
Responsible party
Sponsor
First posted
Sep 8, 2004
Start date
Jan 26, 2005
Primary completion
Jan 30, 2013
Completion
Jan 30, 2013
Last update
Jun 15, 2023

Study contacts

Lynne Wagner, MD
study chair · Robert H. Lurie Cancer Center
Paul E. Goss, MD, PhD
study chair · Massachusetts General Hospital
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

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