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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III, Phase II Treatment Closed postmenopausal MAYO-803201

Objectives

I.  Examine the tolerability of the aminoglutethimide/hydrocortisone/tamoxifen 
regimen.
II.  Compare the tolerability and efficacy (regression rates and duration) of 
the aminoglutethimide/hydrocortisone/tamoxifen regimen with that of tamoxifen 
alone and aminoglutethimide/hydrocortisone alone.
III.  Determine the efficacy of the aminoglutethimide/hydrocortisone regimen 
in a Phase II fashion in women with prior tamoxifen exposure.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients with histologically 
confirmed, inoperable, recurrent or metastatic, estrogen receptor status 
positive or unknown, breast carcinoma, with measurable or evaluable disease.  
Patients must be postmenopausal, clinically suitable for palliative hormonal 
therapy and have no known second primary.  Patients must have a ECOG 
performance status of 3 or better, a serum calcium value less than 12 mg/dl, a 
serum creatinine value of 1.5 mg/d1 or lower and a total bilirubin value less 
than 2 mg/d1.  Patients may receive hormones for medical reasons other than 
the treatment of breast cancer if the dose is stable, equal to or less than 
that which is physiologic, and continuous during the protocol therapy.  
Patients must not have received prior treatment with aminoglutethimide.

Expected Enrollment

Study is expected to accrue 100 patients per year.  Protocol closed May 1984.

Outline

Patients are randomized to Arms I and II.  Those with prior Tamoxifen therapy 
enter Regimen A.
Arm I:  Single-agent Hormone Therapy.  Tamoxifen, TMX, NSC-180973.
Arm II:  3-Drug Hormone Therapy.  Aminoglutethimide, AG; plus Hydrocortisone, 
HC, NSC-10483; plus TMX.
Regimen A:  2-Drug Hormone Therapy.  AG plus HC.

Trial Contact Information

Trial Lead Organizations

Mayo Clinic Cancer Center

James Ingle, MD, Protocol chair		Ph: 507-284-8432 Email: ingle.james@mayo.edu