Status:
COMPLETED
Thyroid Dysfunction in Women With Newly Diagnosed Breast Cancer Compared to Healthy Volunteers
Lead Sponsor:
University of South Florida
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Fatigue
Eligibility:
FEMALE
20-80 years
Brief Summary
RATIONALE: Learning about thyroid dysfunction in patients with breast cancer may help plan treatment and may help patients live more comfortably. PURPOSE: This clinical trial is studying how often th...
Detailed Description
OBJECTIVES: Primary * Compare the proportion of hypothyroidism in women with newly diagnosed stage I-IIIB breast cancer (prior to chemotherapy) vs in cancer-free, age-matched healthy volunteers. * C...
Eligibility Criteria
Inclusion
- CASE SELECTION:
- CASE INCLUSION CRITERIA:
- Women between the ages of 25 and 75
- Diagnosed with primary and operable Stage I - IIIB breast cancer
- Scheduled to receive neoadjuvant or adjuvant Adriamycin and Cytoxan (AC) plus a taxane (taxane may be given with AC or follow AC)
- No chemotherapy prior to baseline sample collection
- No prior history of other cancers (except non-melanoma skin cancer)
- Preoperative radiation therapy is permitted
- No diagnosis of hypothyroidism or hyperthyroidism.
- CASE EXCLUSION CRITERIA:
- Stage IV breast cancer
- Scheduled to receive neoadjuvant hormonal therapy (patients who will receive adjuvant hormonal therapy may participate)
- Received adjuvant hormonal therapy or chemotherapy prior to sample collection
- On chemotherapeutic regimen other than Adriamycin and Cytoxan plus a taxane.
- Patients receiving monoclonal antibodies or other biologic therapy may not participate
- Patients scheduled to receive Herceptin may not participate
- Diagnosed with hyperthyroidism or hypothyroidism. (Women being treated for hypothyroidism are not eligible)
- Women with a baseline TSH of 10 or higher will not continue on study
- Women who are pregnant or lactating are not eligible. (Women of childbearing potential who are planning to become pregnant within the next 24 months should not enroll in this study)
- CONTROL SELECTION:
- CONTROL INCLUSION CRITERIA:
- Cannot be a blood relative of the case. They can be friends, neighbors, women from social activities, local business, doctors' offices, etc.
- Must live near or in the town of the case
- Women between the ages of 20 and 80 (age-matched to cases +/- 5 years)
- No prior history of cancer (except non-melanoma skin cancer)
- Women ages 40 and older should have had a mammogram within 2 years of study entry, showing no evidence of breast cancer.
- The friend control may bring their mammogram report or send a release and have records faxed to the enrolling center.
- Women under the age of 40 should have had a clinical breast examination within 2 years of study entry, showing no need for diagnostic mammography. If a mammogram was required, it should show no evidence of breast cancer.
- The friend control may bring their mammogram / breast exam report or send a release and have records faxed to the enrolling center.
Exclusion
Key Trial Info
Start Date :
April 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
541 Patients enrolled
Trial Details
Trial ID
NCT00336102
Start Date
April 1 2006
End Date
June 1 2015
Last Update
July 9 2015
Active Locations (41)
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1
CCOP - Western Regional, Arizona
Phoenix, Arizona, United States, 85006-2726
2
North Colorado Medical Center
Greeley, Colorado, United States, 80631-5199
3
McKee Medical Center
Loveland, Colorado, United States, 80538
4
Cancer Centers of Central Florida, PA
Leesburg, Florida, United States, 34788