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

June 14, 2023 updated by: Eastern Cooperative Oncology Group

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

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.

Study Overview

Status

Completed

Conditions

Breast Cancer

Intervention / Treatment

Procedure: quality-of-life assessment

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.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Alaska
  - Fairbanks, Alaska, United States, 99701
    - Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital
- Arizona
  - Phoenix, Arizona, United States, 85006
    - Banner Good Samaritan Medical Center
  - Phoenix, Arizona, United States, 85006
    - CCOP - Western Regional, Arizona
  - Phoenix, Arizona, United States, 85306
    - Banner Thunderbird Medical Center
- California
  - Fairfield, California, United States, 94533
    - North Bay Cancer Center
  - Glendale, California, United States, 91204
    - Glendale Memorial Hospital Comprehensive Cancer Center
  - Modesto, California, United States, 95355
    - Memorial Medical Center Cancer Services
  - Palm Springs, California, United States, 92262
    - Comprehensive Cancer Center at Desert Regional Medical Center
- Colorado
  - Fort Collins, Colorado, United States, 80524
    - Poudre Valley Hospital
  - Fort Collins, Colorado, United States, 80524
    - Front Range Cancer Specialists
  - Greeley, Colorado, United States, 80631
    - North Colorado Medical Center
  - Loveland, Colorado, United States, 80539
    - McKee Medical Center
- Florida
  - Fort Lauderdale, Florida, United States, 33308
    - Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
  - Hollywood, Florida, United States, 33021
    - Memorial Cancer Institute at Memorial Regional Hospital
  - Jupiter, Florida, United States, 33458
    - Ella Milbank Foshay Cancer Center at Jupiter Medical Center
  - Miami Beach, Florida, United States, 33140
    - CCOP - Mount Sinai Medical Center
- Georgia
  - Columbus, Georgia, United States, 31902
    - John B. Amos Community Cancer Center
  - Gainesville, Georgia, United States, 30501
    - Northeast Georgia Medical Center
- Illinois
  - Aurora, Illinois, United States, 60507
    - Rush-Copley Cancer Care Center
  - Decatur, Illinois, United States, 62526
    - Decatur Memorial Hospital Cancer Care Institute
  - Geneva, Illinois, United States, 60134
    - Delnor Community Hospital - Geneva
  - Joliet, Illinois, United States, 60435
    - Joliet Oncology Hematology Associates, Limited - West
  - Rockford, Illinois, United States, 61104
    - Swedish American Hospital
  - Springfield, Illinois, United States, 62781-0001
    - Regional Cancer Center at Memorial Medical Center
  - Urbana, Illinois, United States, 61801
    - Carle Cancer Center at Carle Foundation Hospital
  - Urbana, Illinois, United States, 61801
    - CCOP - Carle Cancer Center
- Indiana
  - Beech Grove, Indiana, United States, 46107
    - St. Francis Hospital and Health Centers
  - Elkhart, Indiana, United States, 46515
    - Elkhart General Hospital
  - La Porte, Indiana, United States, 46350
    - Center for Cancer Therapy at LaPorte Hospital and Health Services
  - Michigan City, Indiana, United States, 46360
    - Saint Anthony Memorial Health Centers
  - South Bend, Indiana, United States, 46601
    - Memorial Hospital of South Bend
  - South Bend, Indiana, United States, 46601
    - CCOP - Northern Indiana CR Consortium
  - South Bend, Indiana, United States, 46617
    - Saint Joseph Regional Medical Center
- Iowa
  - Bettendorf, Iowa, United States, 52722
    - Hematology Oncology Associates of the Quad Cities
  - Davenport, Iowa, United States, 52804
    - Genesis Medical Center - West Campus
  - Davenport, Iowa, United States, 52803
    - Genesis Regional Cancer Center at Genesis Medical Center
  - Des Moines, Iowa, United States, 50309
    - CCOP - Iowa Oncology Research Association
  - Des Moines, Iowa, United States, 50309
    - John Stoddard Cancer Center at Iowa Methodist Medical Center
  - Des Moines, Iowa, United States, 50309
    - Medical Oncology and Hematology Associates at John Stoddard Cancer Center
  - Des Moines, Iowa, United States, 50314
    - Medical Oncology and Hematology Associates at Mercy Cancer Center
  - Des Moines, Iowa, United States, 50314
    - Mercy Cancer Center at Mercy Medical Center - Des Moines
  - Des Moines, Iowa, United States, 50316
    - John Stoddard Cancer Center at Iowa Lutheran Hospital
  - Des Moines, Iowa, United States, 50307
    - Mercy Capitol Hospital
  - Mason City, Iowa, United States, 50401
    - Mercy Cancer Center at Mercy Medical Center - North Iowa
  - Sioux City, Iowa, United States, 51101-1733
    - Siouxland Regional Cancer Center
  - Sioux City, Iowa, United States, 51104
    - St. Luke's Regional Medical Center
  - Sioux City, Iowa, United States, 51104
    - Mercy Medical Center - Sioux City
  - Sioux City, Iowa, United States, 51101
    - Siouxland Hematology-Oncology Associates at June E. Nylen Cancer Center
  - West Des Moines, Iowa, United States, 50266
    - Medical Oncology and Hematology Associates - West Des Moines
- Kansas
  - Chanute, Kansas, United States, 66720
    - Cancer Center of Kansas, P.A. - Chanute
  - Dodge City, Kansas, United States, 67801
    - Cancer Center of Kansas, P.A. - Dodge City
  - El Dorado, Kansas, United States, 67042
    - Cancer Center of Kansas, P.A. - El Dorado
  - Kingman, Kansas, United States, 67068
    - Cancer Center of Kansas, P.A. - Kingman
  - Liberal, Kansas, United States, 67901
    - Southwest Medical Center
  - Newton, Kansas, United States, 67114
    - Cancer Center of Kansas, P.A. - Newton
  - Parsons, Kansas, United States, 67357
    - Cancer Center of Kansas, P.A. - Parsons
  - Pittsburg, Kansas, United States, 66762
    - Mount Carmel Regional Cancer Center
  - Pratt, Kansas, United States, 67124
    - Cancer Center of Kansas, P.A. - Pratt
  - Salina, Kansas, United States, 67042
    - Cancer Center of Kansas, P.A. - Salina
  - Wellington, Kansas, United States, 67152
    - Cancer Center of Kansas, P.A. - Wellington
  - Wichita, Kansas, United States, 67214
    - CCOP - Wichita
  - Wichita, Kansas, United States, 67214
    - Via Christi Cancer Center at Via Christi Regional Medical Center
  - Wichita, Kansas, United States, 67214
    - Cancer Center of Kansas, P.A. - Wichita
  - Wichita, Kansas, United States, 67203
    - Associates in Womens Health, P.A. - North Review
  - Wichita, Kansas, United States, 67208
    - Cancer Center of Kansas, P.A. - Medical Arts Tower
  - Winfield, Kansas, United States, 67156
    - Cancer Center of Kansas, P.A. - Winfield
- Massachusetts
  - Medford, Massachusetts, United States, 02155
    - Lawrence Memorial Hospital of Medford
- Michigan
  - Adrian, Michigan, United States, 49221
    - Hickman Cancer Center at Bixby Medical Center
  - Escanaba, Michigan, United States, 49431
    - Green Bay Oncology, Limited - Escanaba
  - Iron Mountain, Michigan, United States, 49801
    - Green Bay Oncology, Limited - Iron Mountain
  - Kalamazoo, Michigan, United States, 49007
    - West Michigan Cancer Center
  - Kalamazoo, Michigan, United States, 49007
    - Bronson Methodist Hospital
  - Kalamazoo, Michigan, United States, 49001
    - Borgess Medical Center
  - Kalamazoo, Michigan, United States, 49001
    - CCOP - Kalamazoo
  - Lambertville, Michigan, United States, 48144
    - Haematology-Oncology Associates of Ohio and Michigan, P.C.
  - Monroe, Michigan, United States, 48162
    - Community Cancer Center of Monroe
  - Monroe, Michigan, United States, 48162
    - Mercy Memorial Hospital System
  - Saginaw, Michigan, United States, 48601
    - Seton Cancer Institute - Saginaw
  - Saint Joseph, Michigan, United States, 49085
    - Oncology Care Associates, P.L.L.C.
- Minnesota
  - Burnsville, Minnesota, United States, 55337
    - Fairview Ridges Hospital
  - Coon Rapids, Minnesota, United States, 55433
    - Mercy and Unity Cancer Center at Mercy Hospital
  - Duluth, Minnesota, United States, 55805
    - CCOP - Duluth
  - Duluth, Minnesota, United States, 55805
    - St. Mary's - Duluth Clinic Cancer Center
  - Duluth, Minnesota, United States, 55805
    - Miller-Dwan Medical Center
  - Duluth, Minnesota, United States, 55805
    - Cancer Care Center at St. Luke's Hospital
  - Edina, Minnesota, United States, 55435
    - Fairview Southdale Hospital
  - Fridley, Minnesota, United States, 55432
    - Mercy and Unity Cancer Center at Unity Hospital
  - Hutchinson, Minnesota, United States, 55350
    - Hutchinson Area Health Care
  - Litchfield, Minnesota, United States, 55355
    - Meeker County Memorial Hospital
  - Maplewood, Minnesota, United States, 55109
    - St. John's Hospital
  - Minneapolis, Minnesota, United States, 55415
    - Hennepin County Medical Center - Minneapolis
  - Minneapolis, Minnesota, United States, 55407
    - Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
  - Robbinsdale, Minnesota, United States, 55422
    - Hubert H. Humphrey Cancer Center at North Memorial Medical Center
  - Saint Cloud, Minnesota, United States, 56303
    - CentraCare Clinic - River Campus
  - Saint Louis Park, Minnesota, United States, 55416
    - CCOP - Metro-Minnesota
  - Saint Louis Park, Minnesota, United States, 55416
    - Park Nicollet Health Services
  - Saint Paul, Minnesota, United States, 55102
    - St. Joseph's Hospital
  - Saint Paul, Minnesota, United States, 55102
    - United Hospital
  - Saint Paul, Minnesota, United States, 55101
    - Regions Hospital Cancer Care Center
  - Shakopee, Minnesota, United States, 55379
    - Saint Francis Cancer Center
  - Waconia, Minnesota, United States, 55387
    - Ridgeview Medical Center
  - Woodbury, Minnesota, United States, 55125
    - Woodwinds Health Campus
- Missouri
  - Joplin, Missouri, United States, 64804
    - St. John's Regional Medical Center
  - Joplin, Missouri, United States, 64804
    - Freeman Cancer Institute at Freeman Health System
  - Kansas City, Missouri, United States, 64131
    - CCOP - Kansas City
  - Saint Louis, Missouri, United States, 63131
    - Missouri Baptist Cancer Center
  - Springfield, Missouri, United States, 65802
    - CCOP - Cancer Research for the Ozarks
  - Springfield, Missouri, United States, 65804
    - St. John's Regional Health Center
  - Springfield, Missouri, United States, 65807
    - Hulston Cancer Center at Cox Medical Center South
- Montana
  - Billings, Montana, United States, 59101
    - CCOP - Montana Cancer Consortium
  - Billings, Montana, United States, 59101
    - Hematology-Oncology Centers of the Northern Rockies - Billings
  - Billings, Montana, United States, 59101
    - Northern Rockies Radiation Oncology Center
  - Billings, Montana, United States, 59101
    - Deaconess Billings Clinic - Downtown
  - Billings, Montana, United States, 59101
    - St. Vincent HealthCare
  - Billings, Montana, United States, 59107
    - Deaconess Billings Clinic Cancer Center
  - Bozeman, Montana, United States, 59715
    - Bozeman Deaconess Hospital
  - Bozeman, Montana, United States, 59715
    - Internal Medicine Associates of Bozeman
  - Butte, Montana, United States, 59701
    - St. James Community Hospital
  - Great Falls, Montana, United States, 59405
    - Great Falls Clinic
  - Great Falls, Montana, United States, 59405
    - Sletten Regional Cancer Institute
  - Helena, Montana, United States, 59601
    - St. Peter's Hospital
  - Kalispell, Montana, United States, 59901
    - Glacier Oncology, PLLC
  - Kalispell, Montana, United States, 59901
    - Kalispell Medical Oncology
  - Miles City, Montana, United States, 59301
    - Eastern Montana Cancer Center
  - Missoula, Montana, United States, 59801
    - Community Medical Center
  - Missoula, Montana, United States, 59802
    - Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
  - Missoula, Montana, United States, 59802
    - Montana Cancer Specialists at Montana Cancer Center
- Nevada
  - Las Vegas, Nevada, United States, 89102
    - University Medical Center of Southern Nevada
  - Las Vegas, Nevada, United States, 89106
    - CCOP - Nevada Cancer Research Foundation
- New Jersey
  - Flemington, New Jersey, United States, 08822
    - Hunterdon Regional Cancer Center at Hunterdon Medical Center
  - Livingston, New Jersey, United States, 07039
    - St. Barnabas Medical Center
- New York
  - Bronx, New York, United States, 10461
    - Albert Einstein Cancer Center at Albert Einstein College of Medicine
- North Carolina
  - Goldsboro, North Carolina, United States, 27534
    - Wayne Memorial Hospital, Incorporated
  - Hendersonville, North Carolina, United States, 28791
    - Pardee Memorial Hospital
  - High Point, North Carolina, United States, 27261
    - High Point Regional Hospital
  - Kinston, North Carolina, United States, 28501
    - Lenoir Memorial Cancer Center
  - Pinehurst, North Carolina, United States, 28374
    - Moore Regional Community Hospital Comprehensive Cancer Center
  - Rutherfordton, North Carolina, United States, 28139
    - Rutherford Hospital
  - Wilson, North Carolina, United States, 27893
    - Wilson Medical Center
- North Dakota
  - Bismarck, North Dakota, United States, 58501
    - Bismarck Cancer Center
  - Bismarck, North Dakota, United States, 58501
    - Cancer Care Center at Medcenter One Hospital
  - Bismarck, North Dakota, United States, 58501
    - Mid Dakota Clinic, P. C.
  - Bismarck, North Dakota, United States, 58501
    - St. Alexius Medical Center
- Ohio
  - Bowling Green, Ohio, United States, 43402
    - Wood County Oncology Center
  - Chillicothe, Ohio, United States, 54601
    - Adena Regional Medical Center
  - Cleveland, Ohio, United States, 44195
    - Cleveland Clinic Taussig Cancer Center
  - Cleveland, Ohio, United States, 44109
    - MetroHealth's Cancer Care Center at MetroHealth Medical Center
  - Cleveland, Ohio, United States, 44106
    - Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University
  - Columbus, Ohio, United States, 43215
    - CCOP - Columbus
  - Columbus, Ohio, United States, 43228
    - Doctors Hospital at Ohio Health
  - Columbus, Ohio, United States, 43214
    - Riverside Methodist Hospital Cancer Care
  - Columbus, Ohio, United States, 43215
    - Grant Riverside Cancer Services
  - Columbus, Ohio, United States, 43222
    - Mount Carmel West Hospital
  - Dayton, Ohio, United States, 45428
    - Veterans Affairs Medical Center - Dayton
  - Dayton, Ohio, United States, 45405
    - Grandview Hospital
  - Dayton, Ohio, United States, 45406
    - Good Samaritan Hospital
  - Dayton, Ohio, United States, 45409
    - David L. Rike Cancer Center at Miami Valley Hospital
  - Dayton, Ohio, United States, 45415
    - Samaritan North Cancer Care Center
  - Dayton, Ohio, United States, 45429
    - CCOP - Dayton
  - Delaware, Ohio, United States, 43015
    - Grady Memorial Hospital
  - Findlay, Ohio, United States, 45840
    - Blanchard Valley Medical Associates
  - Fremont, Ohio, United States, 43420
    - Fremont Memorial Hospital
  - Independence, Ohio, United States, 44131
    - Community Oncology Group - Independence
  - Kenton, Ohio, United States, 43326
    - Kenton Oncology, Incorporated
  - Kettering, Ohio, United States, 45429
    - Charles F. Kettering Memorial Hospital
  - Lancaster, Ohio, United States, 43130
    - Fairfield Medical Center
  - Lima, Ohio, United States, 45804
    - Lima Memorial Hospital
  - Marietta, Ohio, United States, 45750
    - Strecker Cancer Center at Marietta Memorial Hospital
  - Maumee, Ohio, United States, 43537
    - Northwest Ohio Oncology Center
  - Maumee, Ohio, United States, 43537
    - St. Luke's Hospital
  - Middletown, Ohio, United States, 45044
    - Middletown Regional Hospital
  - Newark, Ohio, United States, 43055
    - Licking Memorial Cancer Care Program at Licking Memorial Hospital
  - Oregon, Ohio, United States, 43616
    - St. Charles Mercy Hospital
  - Oregon, Ohio, United States, 43616
    - Toledo Clinic - Oregon
  - Sandusky, Ohio, United States, 44870
    - Firelands Regional Medical Center
  - Sandusky, Ohio, United States, 44870
    - North Coast Cancer Care, Incorporated
  - Springfield, Ohio, United States, 45505
    - Community Hospital of Springfield and Clark County
  - Springfield, Ohio, United States, 45504
    - Mercy Medical Center Oncology Unit
  - Sylvania, Ohio, United States, 43560
    - Promedica Cancer Center at Flower Hospital
  - Tiffin, Ohio, United States, 44883
    - Mercy Hospital of Tiffin
  - Toledo, Ohio, United States, 43608
    - St. Vincent Mercy Medical Center
  - Toledo, Ohio, United States, 43606
    - Toledo Hospital
  - Toledo, Ohio, United States, 43623
    - Toledo Clinic, Incorporated - Main Clinic
  - Toledo, Ohio, United States, 43623
    - CCOP - Toledo Community Hospital
  - Toledo, Ohio, United States, 43614
    - Medical College of Ohio Cancer Institute
  - Toledo, Ohio, United States, 43623
    - Toledo Surgical Specialists
  - Troy, Ohio, United States, 45373
    - UVMC Cancer Care Center at Upper Valley Medical Center
  - Wauseon, Ohio, United States, 43567
    - Fulton County Health Center
  - Westerville, Ohio, United States, 43081
    - Mount Carmel Cancer Services at Mount Carmel St. Ann's Hospital
  - Wooster, Ohio, United States, 44691
    - Cleveland Clinic - Wooster
  - Xenia, Ohio, United States, 45385
    - Ruth G. McMillan Cancer Center at Greene Memorial Hospital
  - Zanesville, Ohio, United States, 43701
    - Genesis - Good Samaritan Hospital
- Oregon
  - Gresham, Oregon, United States, 97030
    - Legacy Mount Hood Medical Center
  - Milwaukie, Oregon, United States, 97222
    - Providence Milwaukie Hospital
  - Portland, Oregon, United States, 97225
    - CCOP - Columbia River Oncology Program
  - Portland, Oregon, United States, 97225
    - Providence St. Vincent Medical Center
  - Portland, Oregon, United States, 97213
    - Providence Cancer Center at Providence Portland Medical Center
  - Portland, Oregon, United States, 97227
    - Institute of Oncology at Vilnius University
  - Portland, Oregon, United States, 97210
    - Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center
  - Tualatin, Oregon, United States, 97062
    - Legacy Meridian Park Hospital
- Pennsylvania
  - Bryn Mawr, Pennsylvania, United States, 19010
    - Bryn Mawr Hospital
  - Paoli, Pennsylvania, United States, 19301
    - Paoli Memorial Hospital
  - Philadelphia, Pennsylvania, United States, 19107
    - Joan Karnell Cancer Center at Pennsylvania Hospital
  - Phoenixville, Pennsylvania, United States, 19460
    - Phoenixville Hospital
  - Pottstown, Pennsylvania, United States, 19464
    - Pottstown Memorial Regional Cancer Center
  - Sellersville, Pennsylvania, United States, 18960
    - Grand View Hospital
  - Wynnewood, Pennsylvania, United States, 19096
    - CCOP - MainLine Health
  - Wynnewood, Pennsylvania, United States, 19096
    - Lankenau Cancer Center at Lankenau Hospital
- South Carolina
  - Anderson, South Carolina, United States, 29621
    - Rose Ramer Cancer Clinic at Anderson Area Medical Center
  - Spartanburg, South Carolina, United States, 29303
    - Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
  - Spartanburg, South Carolina, United States, 29304
    - CCOP - Upstate Carolina
- South Dakota
  - Rapid City, South Dakota, United States, 57701
    - Rapid City Regional Hospital
- Washington
  - Kirkland, Washington, United States, 98033
    - Cascade Cancer Center at Evergreen Hospital Medical Center
  - Port Angeles, Washington, United States, 98362
    - Olympic Medical Center
  - Renton, Washington, United States, 98055
    - Valley Medical Center
  - Seattle, Washington, United States, 98101
    - CCOP - Virginia Mason Research Center
  - Vancouver, Washington, United States, 98668
    - Southwest Washington Medical Center Cancer Center
- Wisconsin
  - Green Bay, Wisconsin, United States, 54303
    - Green Bay Oncology, Limited at St. Mary's Hospital
  - Green Bay, Wisconsin, United States, 54301-3526
    - Green Bay Oncology, Limited at St. Vincent Hospital
  - Green Bay, Wisconsin, United States, 54303
    - St. Mary's Hospital Medical Center
  - Green Bay, Wisconsin, United States, 54301
    - St. Vincent Hospital Regional Cancer Center
  - Oconto Falls, Wisconsin, United States, 54154
    - Green Bay Oncology, Limited - Oconto Falls
  - Sturgeon Bay, Wisconsin, United States, 54235
    - Green Bay Oncology, Limited - Sturgeon Bay
- Wyoming
  - Sheridan, Wyoming, United States, 82801
    - Welch Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 120 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eastern Cooperative Oncology Group

Collaborators

National Cancer Institute (NCI)

NCIC Clinical Trials Group

Investigators

Study Chair: Lynne Wagner, MD, Robert H. Lurie Cancer Center
Study Chair: Paul E. Goss, MD, PhD, Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 26, 2005

Primary Completion (Actual)

January 30, 2013

Study Completion (Actual)

January 30, 2013

Study Registration Dates

First Submitted

September 7, 2004

First Submitted That Met QC Criteria

September 7, 2004

First Posted (Estimated)

September 8, 2004

Study Record Updates

Last Update Posted (Actual)

June 15, 2023

Last Update Submitted That Met QC Criteria

June 14, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

CDR0000380937
U10CA021115 (U.S. NIH Grant/Contract)
ECOG-E1Z03
CAN-NCIC-E1Z03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Breast Cancer | Metastatic Breast Cancer | Stage IV Breast Cancer | Triple-negative Breast Cancer | Recurrent Breast Cancer | Breast Tumor | Cancer of the Breast | Triple-negative Metastatic Breast Cancer | Estrogen Receptor- Negative Breast Cancer | HER2- Negative Breast Cancer | Progesterone Receptor- Negative...

United States, United Kingdom, Italy, Germany, Spain, Canada, Portugal, Australia, Austria, Greece, Brazil, France
University of Southern California
National Cancer Institute (NCI)

Terminated

PET/CT in Evaluating Response to Chemotherapy in Patients With Breast Cancer

HER2-positive Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast Cancer

United States
University of Washington
National Cancer Institute (NCI)

Completed

Combination Chemotherapy and Filgrastim Before Surgery in Treating Patients With HER2-Positive Breast Cancer That Can Be Removed By Surgery

HER2-positive Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Estrogen Receptor-negative Breast Cancer | Estrogen Receptor-positive Breast Cancer | Progesterone Receptor-negative Breast Cancer | Progesterone Receptor-positive Breast...

United States
Baylor Breast Care Center

Recruiting

Correlation of Clinical Response to Pathologic Response in Patients With Early Breast Cancer (RESPONSE)

Breast Cancer | Breast Neoplasm | Triple Negative Breast Cancer | Triple Negative Breast Neoplasms | HER2-positive Breast Cancer | Breast Cancer Stage II | Breast Cancer Female | Breast Cancer Stage III | Estrogen Receptor-positive Breast Cancer | Hormone Receptor-positive Breast Cancer | Breast Cancer Invasive

United States
Innocrin Pharmaceutical

Completed

CYP17 Lyase and Androgen Receptor Inhibitor Treatment With Seviteronel Trial (INO-VT-464-006; NCT02580448) (CLARITY-01)

Breast Cancer | Advanced Breast Cancer | Metastatic Breast Cancer | Triple Negative Breast Cancer | Male Breast Cancer | ER+ Breast Cancer | Cancer of the Breast

United States

Clinical Trials on quality-of-life assessment

Children's Oncology Group
National Cancer Institute (NCI)

Recruiting

Neuropsychological and Behavioral Testing in Younger Patients With Cancer

Childhood Malignant Neoplasm

United States, Canada, Puerto Rico, Australia, New Zealand
Gynecologic Oncology Group
National Cancer Institute (NCI)

Completed

Changes in Brain Function in Patients With Stage I, Stage II, Stage III, or Stage IV Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Who Are Receiving Chemotherapy

Ovarian Clear Cell Cystadenocarcinoma | Ovarian Endometrioid Adenocarcinoma | Ovarian Seromucinous Carcinoma | Ovarian Serous Cystadenocarcinoma | Stage IV Ovarian Germ Cell Tumor | Ovarian Sarcoma | Malignant Ovarian Epithelial Tumor | Ovarian Carcinosarcoma | Ovarian Brenner Tumor | Ovarian Mucinous... and other conditions

United States
Wake Forest University Health Sciences
National Cancer Institute (NCI)

Completed

Cognitive Assessments in Patients With Cancer Undergoing Chemotherapy

Unspecified Adult Solid Tumor, Protocol Specific | Malignant Neoplasm

United States
Wake Forest University Health Sciences

Withdrawn

Cryotherapy in Treating Patients With Lung Cancer That Has Spread to the Other Lung or Parts of the Body

Lung Metastases | Extensive Stage Small Cell Lung Cancer | Recurrent Small Cell Lung Cancer | Recurrent Non-small Cell Lung Cancer | Stage IV Non-small Cell Lung Cancer | Recurrent Malignant Mesothelioma | Advanced Malignant Mesothelioma
City of Hope Medical Center
National Cancer Institute (NCI)

Recruiting

Quality of Life in Cutaneous Lymphoma Patients Using the Skindex29

Cutaneous Lymphoma

United States
M.D. Anderson Cancer Center
National Cancer Institute (NCI)

Recruiting

The Effect of COVID-19 Pandemic on Adolescent and Young Adult Cancer Patients and Survivors

Hematopoietic and Lymphoid Cell Neoplasm | Malignant Solid Neoplasm | COVID-19 Infection

United States
M.D. Anderson Cancer Center
National Cancer Institute (NCI)

Recruiting

Well-Being and Health-Related Quality of Life in Cancer Patients and Survivors During the COVID-19 Pandemic

Hematopoietic and Lymphoid Cell Neoplasm | Malignant Solid Neoplasm | COVID-19 Infection

United States
M.D. Anderson Cancer Center

Active, not recruiting

Longitudinal Evaluation of Women Undergoing Pelvic Surgery for the Treatment of Gynecologic Cancer

Cervical Carcinoma | Endometrial Carcinoma | Vaginal Carcinoma | Malignant Female Reproductive System Neoplasm | Vulvar Carcinoma

United States
Academic and Community Cancer Research United
National Cancer Institute (NCI)

Active, not recruiting

Pemigatinib for the Treatment of Metastatic or Unresectable Colorectal Cancer Harboring FGFR Alterations

Metastatic Colorectal Carcinoma | Stage IV Colorectal Cancer AJCC v8 | Stage IVA Colorectal Cancer AJCC v8 | Stage IVB Colorectal Cancer AJCC v8 | Stage IVC Colorectal Cancer AJCC v8 | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC v8 and other conditions

United States
M.D. Anderson Cancer Center
National Cancer Institute (NCI)

Active, not recruiting

Well-being in Cancer Patients With Neuropathy During COVID-19 Who Participated in Prior Clinical Trials

Hematopoietic and Lymphoid Cell Neoplasm | Malignant Solid Neoplasm | Neuropathy | COVID-19 Infection

United States

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

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

Study Overview

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Clinical Trials on Breast Cancer

Clinical Trials on quality-of-life assessment

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