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	NCI	NCCTG-893253 MAYO-893253, MCGILL-ET-9110, NCCTG-89-32-53

Objectives

I.  Compare response rate, duration of response, time to progression, and 
survival of postmenopausal patients with metastatic or recurrent breast cancer 
randomly assigned to treatment with tamoxifen vs. sandostatin/tamoxifen.

Entry Criteria

Disease Characteristics:

Histologically or cytologically confirmed breast cancer that is
recurrent or metastatic, provided disease is not rapidly
progressive or life-threatening

  Histologic or cytologic proof of recurrent or metastatic
  disease not required for multiple pulmonary nodules known to
  be new or progressive or if there is radiographic evidence of
  multiple bone metastases

  Tumor progression required following prior oophorectomy (if
  performed)

Measurable, evaluable, or unevaluable disease allowed

  Pleural effusions or ascites and blastic or mixed
  lytic/blastic osseous metastasis not considered measurable or
  evaluable

  No CNS metastases as only evidence of disease

Hormone receptor status:
  ER-positive or PgR-positive (or receptor status unknown)

  Every effort should be made to determine receptor status even
  if receptor assays had been performed previously (e.g., at
  time of mastectomy or before prior therapy)

Prior/Concurrent Therapy:

Biologic therapy:
  Not specified

Chemotherapy:
  No prior chemotherapy for advanced breast cancer
  No more than 1 prior adjuvant chemotherapeutic regimen

Endocrine therapy:
  No prior additive hormonal therapy (e.g., estrogens,
  progestins, or androgens)

  Prior adjuvant tamoxifen allowed provided at least 1 year
  elapsed between discontinuation of tamoxifen and diagnosis of
  recurrence

  Less than 30 days since initiation of current tamoxifen

Radiotherapy:
  Not specified

Surgery:
  Not specified

Patient Characteristics:

Age:
  Not specified

Sex:
  Female

Menopausal status:
  Postmenopausal, as defined by one or more of the following:

     No menstrual period for at least 12 months (natural
     menopause)

     Prior oophorectomy

     Prior hysterectomy without oophorectomy and over age 50

Performance status:
  ECOG 0-2

Hematopoietic:
  Not specified

Hepatic:
  Bilirubin less than 0.8 mg/dl above ULN

Renal:
  Calcium less than 10% above ULN

Other:
  No second malignancy that might make origin of metastases
  questionable

Expected Enrollment

A total of 200-300 patients (100-150 per arm) will be accrued over 2.5-3.75 
years.

Outline

Randomized study.

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

Arm II:  Antiestrogen Therapy plus Somatostatin Analogue Therapy.  TMX; plus 
Octreotide, Sandostatin, SSTN, NSC-293562.

Trial Contact Information

Trial Lead Organizations

North Central Cancer Treatment Group

James Ingle, MD, Protocol chair		Ph: 507-284-3731 Email: ingle.james@mayo.edu

Mayo Clinic Cancer Center

James Ingle, MD, Protocol chair		Ph: 507-284-3731 Email: ingle.james@mayo.edu