Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information

Alternate Title

Ovarian Suppression by Surgery Compared With Goserelin in Treating Premenopausal Women With Metastatic Breast Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Closed	18 to 59	NCI	SWOG-8692 EST-8186, NCCTG-873201, INT-0075

Objectives

I.  Compare the time to treatment failure and survival of premenopausal 
patients with metastatic breast carcinoma that is estrogen-receptor-positive 
or progesterone-receptor-positive following treatment with surgical castration 
versus medical castration with the releasing factor agonist goserelin.

II.  Compare response rates in the two treatment groups.

III.  Assess the response rate to surgical castration in patients who have 
failed to respond to or who have relapsed on goserelin, and assess the 
response rate to goserelin in patients who have failed to respond or have 
relapsed after a response to surgical oophorectomy.

IV.  Compare the toxic effects associated with oophorectomy and goserelin 
treatment.

V.  Assess the usefulness of post-treatment levels of luteinizing hormone 
(LH), follicle-stimulating hormone (FSH), and estradiol in predicting the 
response to medical castration.

VI.  Assess the effect of long-term goserelin treatment on levels of LH, FSH, 
and estradiol in responding patients.

Entry Criteria

Disease Characteristics:

Metastatic carcinoma of the breast

No life-threatening progressive disease for which chemotherapy would result in
a more rapid and beneficial response, i.e.:
  No extensive hepatic metastases (greater than one-third the mass of the
     liver)
  No lymphangitic lung metastases

Measurable, evaluable, or unevaluable disease:
  Malignant effusion and bone lesions acceptable as only evidence of disease
  Prior excision of all evidence of metastatic disease not allowed

Hormone receptor status:
  (primary or metastatic tumor assayed)

  Estrogen-receptor (ER) positive (at least 3 fmole/mg protein or positive by
  institutional standards)

  Progesterone-receptor (PR) positive (at least 5 fmole/mg protein or positive
  by institutional standards)

  ER and PR unknown if tumor tissue inaccessible

Prior/Concurrent Therapy:

Biologic therapy:
  Not specified

Chemotherapy:
  Prior adjuvant chemotherapy allowed
  No prior chemotherapy for advanced breast cancer

Endocrine therapy:
  Prior tamoxifen (maximum 3 weeks) allowed if stopped prior to registration
  Prior adjuvant tamoxifen allowed if relapsed 6 or more months after
     completion of therapy
  No other prior hormonal therapy for advanced breast cancer

Radiotherapy:
  Not specified

Surgery:
  Not specified

Patient Characteristics:

Age:
  18 and over

Sex:
  Women only

Menopausal status:
  Premenopausal defined by any of the following:
     Less than 4 months since the last menstrual period (LMP)
     4-12 months since the LMP and a premenopausal FSH level
     Under 50 years old, became amenorrheic while on adjuvant chemotherapy,
        and with a premenopausal FSH level
     Under 60 years old with a hysterectomy (with 1 or both ovaries intact)
        and a premenopausal FSH level

Performance status:
  SWOG 0-2

Hematopoietic:
  Not specified

Hepatic:
  Not specified

Renal:
  Not specified

Other:
  No second malignancy within 5 years except nonmelanomatous skin cancer
  No nonmalignant disease that constitutes an anesthesia risk
  No contraindications to surgical oophorectomy
  No pregnant women
  Barrier contraception required while receiving goserelin

Pretreatment laboratory tests completed within one week of registration,
assessment of active disease sites and chest x-ray within 2 weeks, and other
scans and x-rays within 6 weeks

Expected Enrollment

180 patients will be accrued over 12 years.

Outline

This is a randomized study.  Patients are stratified by participating 
institution, measurability of disease, site of metastases, and institution 
subgroup.

The first group undergoes oophorectomy.

The second group receives goserelin subcutaneously every 4 weeks.  Selected 
patients will be crossed to the first group.

Patients with clearly progressive disease after 6 weeks are removed from study.

Taylor CW, Green S, Dalton WS, et al.: Multicenter randomized clinical trial of goserelin versus surgical ovariectomy in premenopausal patients with receptor-positive metastatic breast cancer: an intergroup study. J Clin Oncol 16 (3): 994-9, 1998.[PUBMED Abstract]

Taylor CW, Green S, Dalton WS, et al.: Phase 3, randomized, multi-center comparison of zoladex versus surgical ovariectomoy in premenopausal patients with receptor positive metastatic breast cancer. [Abstract] Proceedings of the International Congress on Anti-Cancer Treatment 6: A120, 71, 1996.

Taylor CW, Green S, Dalton WS, et al.: A multi-center randomized trial of zoladex versus surgical ovariectomy in pre-menopausal patients with receptor positive metastatic breast cancer. [Abstract] Breast Cancer Res Treat 37 (suppl): A-19, 37, 1995.

Trial Contact Information

Trial Lead Organizations

Southwest Oncology Group

Charles Taylor, MD, Protocol chair(Contact information may not be current)		Ph: 520-626-6044; 800-622-2673

Eastern Cooperative Oncology Group

Nicholas Robert, MD, Protocol chair		Ph: 703-280-5390 Email: nicholas.robert@usoncology.com

North Central Cancer Treatment Group

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

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