Status:
COMPLETED
Breast Density, Hormone Levels, and Anticancer Drug Levels in Women With Invasive Breast Cancer Who Are Receiving Exemestane or Anastrozole
Lead Sponsor:
Alliance for Clinical Trials in Oncology
Collaborating Sponsors:
National Cancer Institute (NCI)
NCIC Clinical Trials Group
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Brief Summary
RATIONALE: Understanding the relationship between breast density, levels of hormones in the blood, and levels of anticancer drugs in the blood may help improve the ability to plan effective treatment ...
Detailed Description
OBJECTIVES: Primary * Assess the change in percent breast density and dense area in response to aromatase inhibitor therapy from pretreatment to 1 year, 1 year to 2 years, and pretreatment to 2 year...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed invasive breast cancer
- Completely resected disease
- One intact, noncancerous breast with no prior breast surgery in that breast except breast biopsy
- Mammogram available taken within 12 months prior to enrollment that includes side- and top-down views of the intact, noncancerous breast
- Estrogen receptor- and/or progesterone receptor-positive tumor
- PATIENT CHARACTERISTICS:
- Female
- Postmenopausal
- Agrees to retrieve and digitize mammograms taken prior to registration (within 12 months prior to atudy entry) and at approximately 1 and 2 years post-registration to this study
- Agrees to have an additional blood banking specimen drawn at the same time as pre-treatment specimens are drawn for parent protocol CAN-NCIC-MA27
- Agrees to have blood sample taken at 12 months post-registration on this study
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- More than 6 months since prior hormone replacement therapy, oral contraceptives, tamoxifen, raloxifene, other selective estrogen-receptor modulators, or gonadotropin releasing-hormone analogues before pre-registration mammogram
Exclusion
Key Trial Info
Start Date :
April 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
554 Patients enrolled
Trial Details
Trial ID
NCT00316836
Start Date
April 1 2006
End Date
February 1 2012
Last Update
January 24 2019
Active Locations (324)
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1
Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital
Fairbanks, Alaska, United States, 99701
2
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259-5499
3
Hembree Mercy Cancer Center at St. Edward Mercy Medical Center
Fort Smith, Arkansas, United States, 72903
4
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205