A Phase II Study of Goserelin Plus Anastrozole for the Treatment of Male Patients With Hormone-Receptor Positive Metastatic or Recurrent Breast Cancer"

Must be male with histologically or cytologically confirmed Stage IV breast carcinoma (local regional recurrence, including axillary and/or chest wall, are eligible; must have tumor(s) that is/are positive for either ER or PR status by IHC; must have measurable or non-measurable disease; assessments for measurable disease w/in 28 days prior to registration, non-measurable disease must be assessed w/in 42 days prior to registration; no more than one prior chemotherapy regimen will be allowed in the metastatic setting; prior tamoxifen is allowed; prior GHRG antagonist, aromatase inhibitors, and fulvestrant are not allowed; must be able to receive oral medications (patients w/ GI-tube are eligible); patients previously treated w/ chemotherapy, hormonal therapy, or RT for recurrent or metastatic disease must be off treatment at least 14 days prior to registration; patients with brain metastases, which are stable for at least 3 months prior to registration and have been treated w/ surgery or RT are eligible; there must be no plans for concurrent treatment w/ chemotherapy, other hormonal therapy (inc/ estrogen-based therapies), or RT may be planned during protocol treatment; patients of reproductive potential may not participate unless they have agreed to use an effective barrier contraceptive method (such as condoms) or abstinence for the duration of the trial and for at least 12 weeks after the end of treatment; must not have known hypersensitivity to LHRH, LHRH agonist analogues, or any of the components of gosereline or anastrozole; must not have active infection requiring systemic therapy; no prior malignancy is allowed except for adequately treated basal cell (or squamous) skin cancer, or other cancer for which the patient has been disease-free for 5 years; must not have evidence of severe or uncontrolled systemic disease (i.e. uncompensated respiratory, cardiac, hepatic, or renal disease); must be HIV negative; >=age 18; PS=0-2