Estradiol Suppression for the Treatment of Metastatic Breast Cancer in Premenopausal Women

Completed · Phase 2

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT00186121

Run by

Stanford University

People needed

35

Starts

2000-10-01

Expected to finish

2013-06-01

Last updated by the study team

2019-10-07

Who can join

Age: 18 and older, up to 70. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Histologically-confirmed, bi-dimensionally measurable, recurrent or metastatic carcinoma of the breast that is progressive
• Premenopausal, defined as any of:
• Last menstrual period within 3 months, or
• Post-hysterectomy without bilateral oophorectomy and with follicle-stimulating hormone (FSH) in the premenopausal range, or,
• 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

Where it is running

• Stanford University School of Medicine — Stanford, California, United States

Full record on ClinicalTrials.gov

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