Examination of Breast Cancer Cells of Pre-menopausal and Post-menopausal Women Before and After Exposure to Tamoxifen or Fulvestrant.
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Fulvestrant; Tamoxifen
Intervention description: fulvestrant 750 mg (three 5 ml injections slowly over 1-2 mn per injection in the buttocks) on day 1 only; 14 days of treatment with tamoxifen 20mg orally each day
Intervention MeSH terms: Tamoxifen; Fulvestrant
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: proliferation Index; Tamoxifen; Fulvestrant; cyclinD1; Breast cancer

Summary:

      The purpose of this study is to microscopically examine breast cancer cells of pre-menopausal
      and post-menopausal women before and after exposure to one of the two commonly used breast
      cancer drugs, tamoxifen or fulvestrant.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent prior to beginning specific protocol procedures, including
             expected cooperation of the patients for the study treatment regimen and follow-up,
             must be obtained and documented according to the local regulatory requirements

          -  Adult women greater than 18 years old

          -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2

          -  New diagnosis of invasive cyclin D1 +, ER+, PR +/-, Her2- breast cancer

               -  Cyclin D1 positive as defined as a total immunohistochemical score of 5 or
                  greater

               -  Hormone receptor positive as defined as ≥ 10% positive stained cells

               -  HER2-normal (IHC score 0-1 or FISH negative [in-situ hybridization (ISH) ratio <=
                  2.0 status])

          -  Tumor size at least 5 mm with planned primary surgery at Mount Sinai

          -  A negative urine dipstick pregnancy test

        Exclusion Criteria:

          -  Estrogen receptor negative invasive breast carcinoma as defined as less than 10%
             stained cells

          -  Prior antiestrogen therapy

          -  Tumor size less than 5 mm

          -  Prior diagnosis of thrombosis or known hypercoagulable state

          -  Known history of bleeding diathesis

          -  Known liver disease

          -  Prior treatment with neoadjuvant therapy

          -  Inflammatory breast cancer defined as clinically significant erythema of the breast
             and/or documented dermal lymphatic invasion (not direct skin invasion by tumor or peau
             d'orange without erythema).

          -  Current severe or uncontrolled systemic disease

          -  Pregnancy or lactation period. Patients of childbearing potential must implement
             adequate non-hormonal contraceptive measures (barrier methods, intrauterine
             contraceptive devices) during study treatment.

          -  Prior malignancy (including invasive or ductal in-situ breast cancer) within 5 years
             prior to randomization, except curatively treated basal cell carcinoma of the skin and
             carcinoma in situ of the cervix.