Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II, Phase I	Treatment	Closed	postmenopausal		MSKCC-88069 NCI-V88-0538

Objectives

I.  Evaluate the biologic effects of daily oral administration of 
4-nitroestrone, 3-methyl ether (NEME).
II.  Seek evidence of therapeutic activity of NEME in patients with advanced 
breast cancer.
III.  Study the pharmacokinetic behavior of NEME.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Postmenopausal women at least 18 
years of age with microscopically confirmed breast cancer and clinical 
evidence of metastatic or locally advanced disease; pathology slides must be 
reviewed by the Department of Pathology at MSKCC.  The primary tumor or 
recurrent lesion must be positive for estrogen and/or progesterone receptors, 
and there must be measurable or evaluable disease (bone scan abnormalities 
alone are not acceptable as evaluable disease; lytic lesions seen on plain 
radiographs are acceptable in conjunction with a bone scan).  Previous 
endocrine therapy for advanced breast cancer is not allowed, but prior 
adjuvant endocrine therapy is permitted if the adjuvant medication was 
discontinued 2 months prior to entry.  There may have been no chemotherapy 
during the 3 weeks prior to entry (6 weeks for mitomycin-C or nitrosoureas); 
patients on glucocorticoid therapy are excluded.  A Karnofsky performance 
status of 60% or greater is required, as are WBC and platelets at least 3,500 
and 100,000, respectively, serum creatinine less than 1.5 or creatinine 
clearance at least 60 ml/minute/1.73 sqm BSA, and serum bilirubin less than 
1.5 mg/dl.  Patients with hypercalcemia or CNS metastases are excluded.

Expected Enrollment

Fourteen patients will be entered initially, with further accrual dependent on 
toxicity and response.

Outline

Nonrandomized study.
Single-agent Antiestrogen Therapy.  4-Nitroestrone, 3-methyl ether, NEME, 
NSC-321803.

Trial Contact Information

Trial Lead Organizations

Memorial Sloan-Kettering Cancer Center

Richard J. Kaufman, MD, Protocol chair(Contact information may not be current)		Ph: 212-639-8895; 800-525-2225