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

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

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment

Intervention(s) in this Clinical Trial

• Drug: Anastrozole (Arimidex)
• Drug: Goserelin (Zoladex)

Primary Measures

• To evaluate the antitumor activity, as measured by frequency of objective response and time to progression, of combination Arimidex and Zoladex in the treatment of premenopausal women with hormone receptor positive, metastatic carcinoma of the breast.
• To evaluate the toxicity of combination Arimidex and Zoladex in the treatment of premenopausal women with hormone receptor positive, metastatic carcinoma of the breast.
• To assess the effectiveness of the combination of Arimidex and Zoladex in suppression of plasma estradiol in premenopausal women with hormone receptor positive, premenopausal breast cancer.

Secondary Measures

• Clinical benefit and survival will also be assessed as secondary endpoints.

• 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.

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 70 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Stanford University

Overall Clinical Trial Officials and Contacts

Robert W Carlson Principal Investigator Stanford University  

Information obtained from ClinicalTrials.gov on December 03, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00186121

Study ID Number: BRSMTS0001

ClinicalTrials.gov Identifier: NCT00186121

Health Authority: United States: Institutional Review Board