Status:
COMPLETED
Estradiol Suppression for the Treatment of Metastatic Breast Cancer in Premenopausal Women
Lead Sponsor:
Stanford University
Collaborating Sponsors:
AstraZeneca
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-70 years
Phase:
PHASE2
Brief Summary
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 posit...
Detailed Description
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 (Arimid...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00186121
Start Date
October 1 2000
End Date
June 1 2013
Last Update
October 7 2019
Active Locations (1)
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1
Stanford University School of Medicine
Stanford, California, United States, 94305