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Keep this study
Lead
Stanford University
With
AstraZeneca
Pre-menopausal women with estrogen and/or progesterone receptor positive, metastatic or recurrent breast cancer were enrolled and treated with goserelin (Zoladex) monthly and began anastrozole (Arimidex) daily for 21 days following the first injection of goserelin. Participants continued on treatment until disease progression or unacceptable toxicity.
Age
18–70
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
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
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
