Status:
COMPLETED
Studying Blood Samples From Women With Breast Cancer or Ductal Carcinoma In Situ Who Are Receiving Tamoxifen
Lead Sponsor:
UNC Lineberger Comprehensive Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Menopausal Symptoms
Eligibility:
FEMALE
21-120 years
Phase:
PHASE2
Brief Summary
RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about differences in DNA and predict how well patients will respond to treatment and plan b...
Detailed Description
OBJECTIVES: Primary * To evaluate the change in endoxifen levels after an increase in tamoxifen citrate dose from 20 mg to 40 mg in women with breast cancer or ductal breast carcinoma in situ with i...
Eligibility Criteria
Inclusion
- Inclusion:
- Histologically confirmed invasive carcinoma of the breast or ductal breast carcinoma in situ Has been receiving tamoxifen citrate at a dose of 20 mg/day for at least 4 months either for the treatment of invasive or non-invasive carcinoma of the breast or for breast cancer recurrence prevention
- Expected duration of tamoxifen citrate treatment at least 6 months Hormone receptor status not specified Concurrent participation in non-treatment studies allowed provided it will not interfere with participation in this study Menopausal status not specified Eastern Cooperative Oncology Group (ECOG) performance status 0-2 Life expectancy ≥ 6 months Absolute Neutrophil Count (ANC) ≥ 1.0 x 10\^9/L Platelet count ≥ 100 x 10\^9/L Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 2.5 times Upper Limit of Normal (ULN) Total bilirubin ≤ 2.5 times ULN Creatinine clearance ≥ 50 mL/min Fertile patients must use effective contraception
- PRIOR CONCURRENT THERAPY:
- No limitations to number of prior therapies
- No limitations for prior radiotherapy
- More than 14 days since prior and no other concurrent investigational agent
- Exclusion:
- Not pregnant or nursing No active, serious infection or medical or psychiatric illness likely to preclude study participation No psychiatric conditions that would preclude study compliance or informed consent No history of venous thromboembolism, transient ischemic attack, or cerebral vascular accident No history of allergic reaction to tamoxifen citrate or any of its reagents No concurrent coumadin
- No concurrent medications known to inhibit CYP2D6, including any of the following:
- Amiodarone
- Haloperidol
- Indinavir
- Ritonavir
- Quinidine
- No concurrent selective serotonin reuptake inhibitors, except the following:
- Venlafaxine
- Citalopram
Exclusion
Key Trial Info
Start Date :
June 18 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
501 Patients enrolled
Trial Details
Trial ID
NCT00764322
Start Date
June 18 2008
End Date
July 1 2011
Last Update
August 1 2017
Active Locations (7)
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1
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7295
2
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte, North Carolina, United States, 28232-2861
3
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
4
Moses Cone Regional Cancer Center at Wesley Long Community Hospital
Greensboro, North Carolina, United States, 27403-1198