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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Completed	over 18	NCI	BGSM-74289 NCI-T89-0113D, T89-0113

Objectives

I.  Compare, in a Phase III setting, response rates and times to treatment 
failure of patients with progressive metastatic carcinoma of the breast who 
are randomly assigned to treatment with tamoxifen vs. high-dose megestrol.

II.  Evaluate the toxicity of high-dose megestrol in these patients.

Entry Criteria

Disease Characteristics:

Histologically confirmed, progressive metastatic carcinoma of
the breast
  Brain metastases, ascites, pleural effusion, and
  lymphangitic spread of tumor are not acceptable as the sole
  evidence of metastatic disease

Measurable or evaluable disease outside prior radiotherapy
fields required

Hormone receptor status:
  ER positive OR
  PgR positive OR
  ER and PgR unknown

Prior/Concurrent Therapy:

Biologic therapy:
  Not specified

Chemotherapy:
  Up to 2 prior chemotherapy regimens allowed

Endocrine therapy:
  Prior adjuvant antiestrogen therapy allowed provided
  treatment was stopped at least 1 year prior to entry

  No prior progestin therapy for breast cancer allowed

  No concurrent progestin therapy for nonmalignant disease
  allowed

Radiotherapy:
  Prior or concurrent radiotherapy allowed

Surgery:
  Not specified

Patient Characteristics:

Age:
  Over 18

Performance status:
  0-3

Hematopoietic:
  Not specified

Hepatic:
  Alkaline phosphatase required within 1 week prior to entry

Renal:
  Not specified

Pulmonary:
  Chest x-ray required within 4 weeks prior to admission (1
  week in patients with symptomatic pulmonary involvement)

Other:
  No second malignancy in the past 5 years except:
     Nonmelanomatous skin cancer
     In situ carcinoma of the cervix

Physical examination and preadmission blood work required
within 1 week prior to admission; bone scan and/or bone survey
and liver scan (if required) within 4 weeks of entry
  Normal bone scan within 3 months prior to entry is
  acceptable in asymptomatic patients who have a normal
  alkaline phosphatase 1 week prior to entry

Expected Enrollment

70-210 evaluable patients will be required; an accrual rate of at least 40 
patients/year is anticipated.

Outline

Randomized study, with crossover for patients who develop progressive disease 
or intolerable toxicity.

Arm I:  Progestin Therapy.  High-dose Megestrol, MEG, NSC-71423.

Arm II:  Antiestrogen Therapy.  Tamoxifen, TMX, NSC-180973.

Trial Contact Information

Trial Lead Organizations

Wake Forest University Comprehensive Cancer Center

Hyman Muss, MD, Protocol chair		Ph: 802-656-5487; 800-358-1144