Anti-Hormone Therapy (With Anastrazole and Fulvestrant) Before Surgery to Treat Postmenopausal Women With Breast Cancer.
Condition: Invasive Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Fulvestrant; Anastrazole
Intervention description: Fulvestrant IM on day 14 and on day 28 followed by day 28 of all subsequent cycles thereafter. Treatment will be continued for a total of 4 cycles.; Anastrazole, 1mg by mouth every day of all 28 day cycles and continued for a total of 4 cycles
Intervention MeSH terms: Fulvestrant; Anastrozole
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 42.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: hormone receptor positive; invasive breast cancer; endocrine therapy; Anastrazole; Fulvestrant; breast tumors; postmenopausal

Summary:

      This study is being done to test the safety and effectiveness of two drugs, Anastrozole and
      Fulvestrant, used as combined therapy in the neo-adjuvant setting for hormone receptor
      positive invasive breast cancer.
    

Eligibility criteria:

        Inclusion criteria

          -  Female patient > 18 years of age.

          -  Histologically proven invasive adenocarcinoma of the breast.

          -  Patients must be candidates for neoadjuvant treatment (Tumor size > 2cm and/or
             clinical N1 or N2).

          -  ER positive (> 10% of cells) and/or PgR positive (> 10% of the cells) and HER-2
             negative disease (IHC 0 or 1+ and/or FISH negative, IHC 2+ and FISH negative)

          -  Menopausal status

               -  Patients must be post-menopausal as defined by one of the following criteria:

                    -  Prior bilateral oophorectomy

                    -  12 months since LMP with no prior hysterectomy

                    -  Patients > 55 years with prior hysterectomy

                    -  Patients < 55 years of age and with a prior hysterectomy without
                       oophorectomy, estradiol and FSH levels must be consistent with the patient
                       being postmenopausal.

               -  Premenopausal or perimenopausal women who do not meet the postmenopausal criteria
                  above are also eligible, but are required to undergo ovarian suppression with an
                  LHRH agonist. Ovarian suppression can be initiated any time prior to or on day 1
                  of protocol therapy and must continue throughout protocol therapy.

          -  Performance status of 2 or better per SWOG criteria

          -  No prior chemotherapy or endocrine therapy for the current cancer diagnosis.

          -  If female of childbearing potential, pregnancy test is negative prior to initiation of
             ovarian suppression.

          -  Patients must be informed of the investigational nature of the study, and must sign an
             informed consent in accordance with the institutional rules.

          -  Oncotype Dx Recurrence Score </= 25.

        Exclusion criteria

          -  Patients with metastatic disease.

          -  The presence of any other medical or psychiatric disorder that, in the opinion of the
             treating physician, would contraindicate the use of drugs in this protocol or place
             the subject at undue risk for treatment complications.

          -  Premenopausal without ovarian suppression.

          -  Pregnancy or lactation.

          -  Patients with concomitant or previous malignancies within the last 5 years, with the
             exception of adequately treated basal or squamous cell carcinoma of the skin or
             carcinoma in situ of the cervix.

          -  Patients with emotional limitations are excluded from study

          -  Platelets less than 100 x 109 /L

          -  Total bilirubin greater than 1.5 x ULRR

          -  ALT or AST greater than 2.5 x ULRR

          -  History of bleeding diathesis (i.e., disseminated intravascular coagulation [DIC],
             clotting factor deficiency) or long-term anticoagulant therapy (other than
             antiplatelet therapy).

          -  History of hypersensitivity to active or inactive excipients of fulvestrant (i.e.
             castor oil or Mannitol).

          -  Oncotype Dx Recurrence Score of >25.