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Clinical Trial Name - Quality of Life in Postmenopausal Women Who Are Receiving Either Exemestane or Anastrozole With or

 
Original Study ID : CDR0000380937
Secondary ID : Array
NCT ID : NCT00090974
Brief Title : 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
Official Title : 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
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.

Source : National Cancer Institute (NCI)
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.

Overall Status : Active, not recruiting
Start Date : December 2004
Official Title : N/A
Phase : Observational
Study Design : N/A
Verification Date : January 2006
First Received Date : September 7, 2004
Trial 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
Gender : Female
Minimum Age : N/A
Maximum Age : N/A
Healthy Volunteers : No
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Facility Name : Wood County Oncology Center
City : Bowling Green
State : Ohio
Zip Code : 43402
Country : United States
Facility Name : CCOP - Columbia River Oncology Program
City : Portland
State : Oregon
Zip Code : 97225
Country : United States
Facility Name : Institute of Oncology at Vilnius University
City : Portland
State : Oregon
Zip Code : 97227
Country : United States
Facility Name : Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center
City : Portland
State : Oregon
Zip Code : 97210
Country : United States
Facility Name : Legacy Meridian Park Hospital
City : Tualatin
State : Oregon
Zip Code : 97062
Country : United States
Facility Name : Legacy Mount Hood Medical Center
City : Glesham
State : Oregon
Zip Code : 97030
Country : United States
Facility Name : Providence Cancer Center at Providence Portland Medical Center
City : Portland
State : Oregon
Zip Code : 97213
Country : United States
Facility Name : Providence Milwaukie Hospital
City : Milwaukie
State : Oregon
Zip Code : 97222
Country : United States
Facility Name : Providence St. Vincent Medical Center
City : Portland
State : Oregon
Zip Code : 97225
Country : United States
Facility Name : Bryn Mawr Hospital
City : Bryn Mawr
State : Pennsylvania
Zip Code : 19010
Country : United States
Facility Name : CCOP - MainLine Health
City : Wynnewood
State : Pennsylvania
Zip Code : 19096
Country : United States
Facility Name : Grand View Hospital
City : Sellersville
State : Pennsylvania
Zip Code : 18960
Country : United States
Facility Name : Joan Karnell Cancer Center at Pennsylvania Hospital
City : Philadelphia
State : Pennsylvania
Zip Code : 19107
Country : United States
Facility Name : Lankenau Cancer Center at Lankenau Hospital
City : Wynnewood
State : Pennsylvania
Zip Code : 19096
Country : United States
Facility Name : Paoli Memorial Hospital
City : Paoli
State : Pennsylvania
Zip Code : 19301
Country : United States
Facility Name : Phoenixville Hospital
City : Phoenixville
State : Pennsylvania
Zip Code : 19460
Country : United States
Facility Name : Pottstown Memorial Regional Cancer Center
City : Pottstown
State : Pennsylvania
Zip Code : 19464
Country : United States
Facility Name : CCOP - Upstate Carolina
City : Spartanburg
State : South Carolina
Zip Code : 29304
Country : United States
Facility Name : Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
City : Spartanburg
State : South Carolina
Zip Code : 29303
Country : United States
Facility Name : Rose Ramer Cancer Clinic at Anderson Area Medical Center
City : Anderson
State : South Carolina
Zip Code : 29621
Country : United States
Facility Name : Rapid City Regional Hospital
City : Rapid City
State : South Dakota
Zip Code : 57701
Country : United States
Facility Name : Cascade Cancer Center at Evergreen Hospital Medical Center
City : Kirkland
State : Washington
Zip Code : 98033
Country : United States
Facility Name : CCOP - Virginia Mason Research Center
City : Seattle
State : Washington
Zip Code : 98101
Country : United States
Facility Name : Olympic Medical Center
City : Port Angeles
State : Washington
Zip Code : 98362
Country : United States
Facility Name : Southwest Washington Medical Center Cancer Center
City : Vancouver
State : Washington
Zip Code : 98668
Country : United States
Facility Name : Valley Medical Center
City : Renton
State : Washington
Zip Code : 98055
Country : United States
Facility Name : Green Bay Oncology, Limited - Oconto Falls
City : Oconto Falls
State : Wisconsin
Zip Code : 54154
Country : United States
Facility Name : Green Bay Oncology, Limited - Sturgeon Bay
City : Sturgeon Bay
State : Wisconsin
Zip Code : 54235
Country : United States
Facility Name : Green Bay Oncology, Limited at St. Mary's Hospital
City : Green Bay
State : Wisconsin
Zip Code : 54303
Country : United States
Facility Name : Green Bay Oncology, Limited at St. Vincent Hospital
City : Green Bay
State : Wisconsin
Zip Code : 54301-3526
Country : United States
Facility Name : St. Mary's Hospital Medical Center
City : Green Bay
State : Wisconsin
Zip Code : 54303
Country : United States
Facility Name : St. Vincent Hospital Regional Cancer Center
City : Green Bay
State : Wisconsin
Zip Code : 54301
Country : United States
Facility Name : Welch Cancer Center
City : Sheridan
State : Wyoming
Zip Code : 82801
Country : United States
Interventions
Type : Procedure
Name : quality-of-life assessment
 
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