Clinical Research Details
Title:
SWOG S0230 Phase III Trial of LHRH Analog Administration During Chemotherapy to Reduce Ovarian Failure Following Standard Adjuvant Chemotherapy in Early Stage, Hormone Receptor Negative Breast Cancer
Purpose:
The purpose is to compare the rate of premature ovarian failure at two years following standard adjuvant chemo with/without ovarian supression with LHRH analog during chemo in premenopausal women with early stage, hormone-receptor negative breast cancer.
Study Number:
107001
Number of Patients:
416
Elgibility:
Candidates must be between the ages of 18 and 50 years; premenopausal women with histological confirmed diagnosis of operable stage I, II, or IIIA invasive breast cancer; must have had mastectomy or local excision of all tumor plus axillary node dissection; must be registered within 84 days after the final surgical procedure; no prior chemo history; and performance status of 0-2. Tumors must be estrogen receptor-negative AND progesterone receptor-negative. The treatment plan must include 3-6 months or cycles of alkylating chemo.
Treatment:
Patients will be placed in one of two groups (randomized study). Group 1 will receive the planned post-operative chemotherapy for breast cancer. Group 2 also will receive chemotherapy but will receive a hormone injection given through a needle just under the skin. This injection will be given one week before chemotherapy starts and will continue once every four weeks for the length of chemotherapy
Principal Investigator:
Enrollment Phone:
(708) 327-3222