Phase II Therapy with Trilostane plus HC for Women with Advanced Breast Cancer Who Have Had Prior Hormonal Therapy

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Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IITreatmentClosedno age specifiedNCINCCTG-833202
MAYO-833202, NCCTG-83-32-02


I.  Obtain data concerning the efficacy (regression rate and time to 
progression) and tolerability of trilostane in a Phase II setting in women 
with advanced breast cancer who have had prior hormonal therapy.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Female patients with histologically 
confirmed progressive metastatic carcinoma of the breast.  Patients must be 
postmenopausal (i.e., no menstrual period for at least 12 months in the case 
of natural menopause or, in the case of those with a prior hysterectomy 
without bilateral oophorectomy, at least 55 years of age) or previously 
castrated in the case of prior premenopausal status.  Patients must have 
received one or two prior hormonal manipulations; additive hormonal therapy 
must have stopped prior to entry.  In the case of patients who have responded 
to estrogen therapy, at least 4 weeks must have elapsed from the time of 
estrogen withdrawal, with progression of disease in the interim.  In the case 
of patients who have received a depot form of hormonal therapy, at least 8 
weeks must have elapsed since the last administration.  Patients must have had 
a response to hormonal manipulation immediately prior to entry or be known to 
have a tumor that is estrogen receptor-positive at the time of entry.  Prior 
aminoglutethimide, bilateral adrenalectomy, or hypophysectomy excludes.  There 
may be no prior chemotherapy except for adjuvant chemotherapy.  Measurable 
indicator lesions are required; patients with CNS metastases, malignant 
pleural effusions or ascites, blastic or mixed lytic/blastic osseous 
metastases as the only evidence of disease are ineligible.  Hepatic metastases 
involving more than one-third of the liver exclude.  Patients receiving 
non-sex hormones that may influence the course of breast cancer (i.e., 
corticosteroids, thyroid) are eligible if they are taking the drug at least 
one month prior to entry, if progressive disease is noted prior to entry 
during the administration of this drug, if the drug dose is stable or 
decreasing, and, in the case of corticosteroids, if the dosage is no more than 
the equivalent of 10 mg of prednisone daily.  An ECOG performance status of 2 
or better and adequate liver and kidney function are required (per Addendum 1, 
November 1985, creatinine and total bilirubin must be less than 0.8 mg/dl 
above the upper limit of institutional normal value).  Serum calcium must be 
less than 12 mg/dl (less than 1.9 mg/dl above the upper limit of institutional 
normal value, per Addendum 1); hypercalcemia must be manageable with hydration 
without the addition of corticosteroids or mithramycin.  There may have been 
no second known primary cancer that might make the origin of metastases 

Expected Enrollment

20 patients will be entered initially; if 3 or more have tumor regression, an 
additional 15 patients will be entered.


Nonrandomized study.
Adrenal Blockade with Replacement Therapy.  Trilostane; Hydrocortisone, HC, 

Published Results

Ingle JN, Krook JE, Schaid DJ, et al.: Evaluation of trilostane plus hydrocortisone in women with metastatic breast cancer and prior hormonal therapy exposure. Am J Clin Oncol 13 (2): 93-7, 1990.[PUBMED Abstract]

Ingle JN, Krook JE, Everson LK, et al.: Evaluation of trilostane plus hydrocortisone in women with metastatic breast cancer and prior hormonal therapy exposure. [Abstract] Proceedings of the American Society of Clinical Oncology 6: A-235, 60, 1987.

Trial Contact Information

Trial Lead Organizations

North Central Cancer Treatment Group

James Ingle, MD, Protocol chair
Ph: 507-284-3731

Mayo Clinic Cancer Center

James Ingle, MD, Protocol chair
Ph: 507-284-3731

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.