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

Alternate Title

Ovarian Suppression in Treating Premenopausal Women Receiving Adjuvant Chemotherapy for Poor-Prognosis Nonmetastatic Breast Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Closed premenopausal FRE-FNCLCC-9456 NCI-F94-0023

Objectives

I.  Determine whether ovarian suppression increases the survival of 
premenopausal women receiving adjuvant chemotherapy for poor-prognosis 
nonmetastatic breast carcinoma.

Entry Criteria

Disease Characteristics:

Primary, nonmetastatic adenocarcinoma of the breast being treated with
adjuvant chemotherapy

Poor prognosis required (patients for whom systemic adjuvant chemotherapy is
prescribed), e.g.:
  Node-positive, any hormone receptor status, any SBR grade
                     OR
  Node-negative, estrogen-negative and progesterone-negative, SBR grade II/III

Hormone receptor status must be obtained prior to any chemotherapy

The following exclude:
  Inflammatory breast cancer
  Carcinomatous mastitis
  Bilateral breast cancer

Prior/Concurrent Therapy:

Adjuvant chemotherapy required for current breast cancer
Pre- or perioperative chemotherapy for current diagnosis allowed
No prior therapy for a previous breast cancer

Patient Characteristics:

Age:
  Not specified

Sex:
  Women only

Menopausal status:
  Premenopausal, i.e., one of the following:
     At least 1 menarche episode within the 3 months preceding diagnosis
     Plasma estradiol level at least 60 pmole/mL
     FSH less than 30 mU/mL

Performance status:
  Not specified

Hematopoietic:
  Not specified

Hepatic:
  Not specified

Renal:
  Not specified

Other:
  No second malignancy except:
     Nonmelanomatous skin cancer
     In situ cervical carcinoma
  Available for follow-up

Expected Enrollment

1,000 patients will be studied.

Outline

This is a randomized study.  Patients are stratified by participating 
institution, hormone receptor status, and (at one site) by the adjuvant 
chemotherapy regimen.

The first group receives no additional treatment, while the second group 
undergoes ovarian suppression by one of three methods:  pelvic irradiation; 
ovariectomy; or LHRH agonist therapy with triptorelin given every 4 weeks for 
3 years.

Concurrent locoregional radiotherapy is permitted; tamoxifen or other hormonal 
treatment is not allowed.  Other ancillary therapy may be given according to 
the discretion of the treatment center provided it is the same for both arms.

Patients are followed every 6 months for 2.5 years, then yearly.

Trial Contact Information

Trial Lead Organizations

Federation Nationale des Centres de Lutte Contre le Cancer

Rodrigo Arriagada, MD, Protocol chair		Ph: 33-1-42-115-360 Email: arriagada@igr.fr