A Phase II Trial of Arimidex Plus Zoladex in the Treatment of Hormone Receptor Positive, Metastatic Carcinoma of the Breast in Premenopausal Women

Inclusion Criteria:

- Patients must have a histologically confirmed, bi-dimensionally
measurable, recurrent or metastatic carcinoma of the breast that is progressive.

- All patients must be female and premenopausal. Premenopausal is defined as either:
(1) last menstrual period within 3 months, or (2) post-hysterectomy without bilateral
oophorectomy and with FSH in the premenopausal range, or, (3) if on tamoxifen within
the past 3 months, a plasma estradiol in the premenopausal range.

- Patients must have either positive estrogen and/or progesterone receptor
determination by 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.

- No prior treatment with an aromatase inhibitor or inactivator.

- No prior treatment with an LH/RH agonist/antagonist.

- No adjuvant chemotherapy within 6 months of study entry.

- Patients must have an ECOG performance status of 0, 1, or 2.

- Patients must have adequate bone marrow, hepatic, and renal function defined by the
following:

- Granulocytes > 1500/mm^3

- Platelets > 100,000/mm^3

- SGOT < 2.5x upper limit of normal

- Total bilirubin < 1.5 mg/dL

- Patients with central nervous system metastasis or lymphangitic pulmonary metastasis
are not eligible.

- Patients must not have received chemotherapy or hormonal therapy for at least 3 weeks
prior to enrollment.

- Patients may receive irradiation to bony sites of disease for pain control or for
prevention of fracture, but the irradiated site(s) will NOT be considered evaluable
for disease response.

- Patients who are pregnant or lactating are ineligible. Must be using effective
contraception or not be of childbearing potential.

- Patients must not have had an active malignancy other than breast cancer, in situ
carcinoma of the cervix, or non-melanomatous skin cancers in the past 5 years.

- No active, unresolved infection.

- All patients must give signed written informed consent.