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	Closed	postmenopausal/over 18		CG-CGS-16949A-06 NCI-V90-0171

Objectives

I.  Compare, in a randomized, double-blind, multi-institutional, Phase III 
setting, the effect of CGS 16949A vs. megestrol on tumor response rate in 
postmenopausal women who have undergone potentially curative primary therapy 
for receptor-positive carcinoma of the breast and who have relapsed while on 
hormone therapy.

II.  Compare the objective survival, time to progression, time to treatment 
failure, performance status, quality of life, pain, and toxicity in these 2 
treatment groups.

Entry Criteria

Disease Characteristics:

Histologically proven carcinoma of the breast that has relapsed
while on a hormone regimen received for at least 3 months
following potentially curative surgical resection

  Adjuvant chemotherapy and/or radiotherapy in addition to
  primary surgery allowed

Bulk of disease measurable or evaluable by direct measurement,
photography, or radiography

  No requirement for radiotherapy to only area of measurable
  disease

No extensive hepatic metastases

No CNS metastases

Hormone receptor status:
  ER and/or PR positive or unknown

Prior/Concurrent Therapy:

Biologic therapy:
  At least 7 days since prior anticancer therapy

Chemotherapy:
  Prior adjuvant chemotherapy allowed
  At least 7 days since prior anticancer therapy

Endocrine therapy:
  Failure after at least 3 months of hormonal therapy required
  At least 7 days since hormone therapy
  No prior therapy with study agents
  Adequate washout period required (7 days for topical and 30
     days for systemic investigational drugs)

Radiotherapy:
  Prior radiotherapy allowed

Surgery:
  Prior potentially curative surgical resection required

Patient Characteristics:

Age:
  At least 18

Sex:
  Females only

Menopausal status:
  Postmenopausal, i.e., one of the following:
     Bilateral oophorectomy or radiation castration

     At least 5 years beyond spontaneous menopause

     Plasma FSH and LH levels greater than 40 mIU/ml
     in patients less than 5 years beyond spontaneous menopause
     or chemotherapy-induced amenorrhea

Performance status:
  Karnofsky 60-100% (ECOG/WHO 0-2)

Life expectancy:
  At least 6 months

Hematopoietic:
  WBC greater than 3,000
  AGC greater than 1,500
  Platelets greater than 100,000

Hepatic:
  Bilirubin less than 1.5 mg/dl
  SGOT less than 2 x ULN
  Alkaline phosphatase less than 2 x ULN (or GGPT less than 2 x
     ULN if alkaline phosphatase is above entry level)
  PT less than 1.5 x control

Renal:
  Creatinine less than 2.0 mg/dl
  Calcium less than 11 mg/dl

Cardiovascular:
  No uncontrolled cardiac disease (e.g., CHF)

Other:
  No uncontrolled diabetes mellitus
  No second malignancy except:
     Cone-biopsied in situ carcinoma of the cervix
     Adequately treated nonmelanomatous skin cancer

Expected Enrollment

240 patients will be required; the estimated accrual period is 18 months.  At 
least 40 centers will participate, with each center supplying a minimum of 6 
patients.

Outline

Randomized study.

Arm I:  Aromatase Inhibition Therapy.  CGS 16949A; plus Placebo.

Arm II:  Progestin Therapy.  Megestrol, MEG, NSC-71423; plus Placebo.

Trial Contact Information

Trial Lead Organizations

Ciba-Geigy Corporation

Edward Miller, MD, Protocol chair		Ph: 201-277-4994