Studying Blood Samples From Women With Breast Cancer or Ductal Carcinoma In Situ Who Are Receiving Tamoxifen
Condition: Breast Cancer; Menopausal Symptoms
MeSH terms: Breast Neoplasms; Carcinoma in Situ
Intervention: tamoxifen citrate; gene expression analysis; pharmacogenomic studies; questionnaire administration; quality-of-life assessment
Intervention description: Women found to be IM or PM will undergo increased tamoxifen to 40 mg/day (20 mg bid). Drug is given orally on a daily basis.; Genetic analysis of blood sample.; Genetic analysis of blood sample.; Questionnaire called the survey of participants. Questionnaires is self administered on paper documents and given pre-study, and at 4 months; Self administration of a multiquestion questionnaire called the Functional Assessment of Cancer Therapy -Breast (FACT-B). Given pre-study, at 4 months and at 8-10 months.
Intervention MeSH terms: Tamoxifen
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 501.0
Sex: Female
Minimum age: 21 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: menopausal symptoms; recurrent breast cancer; stage I breast cancer; stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer; stage IV breast cancer; ductal breast carcinoma in situ; breast cancer in situ

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 better treatment.

      PURPOSE: This clinical trial is studying blood samples from women with breast cancer or
      ductal carcinoma in situ who are receiving tamoxifen.
    

Eligibility criteria:

        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