Estrogen for Triple Negative Breast Cancer
Condition: Female Breast Cancer
MeSH terms: Breast Neoplasms; Triple Negative Breast Neoplasms
Intervention: Estradiol
Intervention description: 10mg oral three times daily
Intervention MeSH terms: Estradiol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 17.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Breast Cancer

Summary:

      The purpose of this study is to determine the effectiveness of Estradiol treatment for
      advanced breast cancer that is hormone receptor negative and Her2/neu negative. The study
      will also use tumor tissue from your original diagnosis or from a biopsy you may have had for
      your cancer to look at hormone receptors in the lab. The tissue left over from your previous
      surgery or a previous biopsy will be used for research tests to check whether a different
      estrogen receptor (estrogen receptor beta) is seen in the tumor and if that makes estrogen
      work better.
    

Eligibility criteria:

        Inclusion Criteria:

          -  histologically or cytologically confirmed breast cancer which is metastatic.

          -  A formalin-fixed paraffin embedded tumor block (preferred) or unstained slides must be
             available from either a prior biopsy of the primary tumor or a metastatic site. .

          -  Primary tumor or metastatic biopsy lacking estrogen and progesterone receptor and Her2
             negative

          -  Patients must have measurable disease.

          -  Eastern Cooperative Oncology Group performance status 0-1.

          -  Patients with bone metastasis at baseline must agree to treatment with intravenous
             bisphosphonates

          -  Subjects may have had 0-4 lines of prior systemic chemotherapy or targeted therapy
             regimens administered for treatment of their metastatic breast cancer.

          -  Age >18 years

          -  Life expectancy of greater than 3 months.

          -  Patients must have adequate organ and marrow function as defined below:

        Exclusion Criteria:

          -  systemic chemotherapies, targeted therapies or radiotherapy for their cancer within 2
             weeks prior to entering the study

          -  Patients receiving any other investigational agents for breast cancer treatment.

          -  Patients with known brain metastases are excluded 3.2.4 History of allergic reactions
             attributed to compounds of similar chemical or biologic composition to estradiol.

          -  Patients with any condition of the gastrointestinal tract that is expected to result
             in an inability to take oral medication

          -  Dysfunctional or post-menopausal vaginal bleeding.

          -  Uncontrolled hypercalcemia/hypocalcemia

          -  Prior history of or active thrombophlebitis, cerebral vascular accident, myocardial
             infarction, deep venous thrombosis or pulmonary embolism.

          -  History of or active hepatic adenoma.

          -  Uncontrolled intercurrent illness

          -  Pregnant women are excluded from this study

          -  Patients with bone metastasis are excluded if they are unable to receive intravenous
             bisphosphonate therapy due to the risk for developing hypercalcemia.