Education and Training
Estradiol Suppression for the Treatment of Metastatic Breast Cancer in Premenopausal Women
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.
Stanford is currently not accepting patients for this trial.
Intervention(s):
- drug: Anastrozole (Arimidex)
- drug: Goserelin (Zoladex)
Eligibility
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
Ages Eligible for Study
18 Years - 70 Years
Genders Eligible for Study
Female
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Mary Chen
6507238686
Not Recruiting