Estradiol Suppression for the Treatment of Metastatic Breast Cancer in Premenopausal Women
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Anastrozole (Arimidex); Goserelin (Zoladex)
Intervention description: Anastrozole is a prescription hormonal treatment that helps fight breast cancer by lowering the amount of estrogen in the body. It is a non-steroidal aromatase inhibitor, which significantly lowers serum estradiol (estrogen) concentrations, without interfering with the formation of adrenal corticosteroids or aldosterone; Goserelin is a palliative treatment of advanced breast cancer in pre- and perimenopausal women
Intervention MeSH terms: Anastrozole; Goserelin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: Female
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      To evaluate the antitumor activity, toxicity, and effectiveness of the combination of
      goserelin (Zoladex) and anastrozole (Arimidex) in the treatment of premenopausal women with
      hormone receptor positive metastatic carcinoma of the breast.
    

Eligibility criteria:

        INCLUSION CRITERIA

          -  Histologically-confirmed, bi-dimensionally measurable, recurrent or metastatic
             carcinoma of the breast that is progressive

          -  Premenopausal, defined as any of:

               1. Last menstrual period within 3 months, or

               2. Post-hysterectomy without bilateral oophorectomy and with follicle-stimulating
                  hormone (FSH) in the premenopausal range, or,

               3. If tamoxifen administered within the past 3 months, plasma estradiol must be in
                  the premenopausal range

          -  Either positive estrogen and/or progesterone receptor determination by
             Immunohistochemistry (IHC) or competitive binding assay on metastatic disease, or if
             not performed on their metastatic disease a positive result on their primary breast
             cancer specimen.

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2

          -  Granulocytes > 1500/mm^3

          -  Platelets > 100,000/mm^3

          -  Serum glutamic oxaloacetic transaminase (SGOT) < 2.5 x upper limit of normal

          -  Total bilirubin < 1.5 mg/dL

          -  May have received irradiation to bony sites of disease for pain control or for
             prevention of fracture. The irradiated site(s) will NOT be evaluable for disease
             response.

          -  Must be using effective contraception or not be of childbearing potential

          -  Signed written informed consent

        INCLUSION CRITERIA

          -  Active, unresolved infection

          -  Active malignancy other than breast cancer, in situ carcinoma of the cervix, or
             non-melanomatous skin cancers in the past 5 years

          -  Prior treatment with an aromatase inhibitor or inactivator

          -  Prior treatment with an luteinizing hormone-releasing hormone (LH/RH)
             agonist/antagonist

          -  Adjuvant chemotherapy within 6 months of study entry.

          -  Received chemotherapy or hormonal therapy in the 3 weeks prior to enrollment

          -  Central nervous system metastasis

          -  Lymphangitic pulmonary metastasis

          -  Pregnant or lactating