Phase III Trial of LHRH Analog Administration During Chemotherapy to Reduce Ovarian Failure Following Chemotherapy in Early Stage, Hormone-Receptor Negative Breast Cancer

Premenopausal women with a histologically confirmed diagnosis of operable Stage I, II, IIIA invasive breast cancer; patients who have completed surgery must have pathologic Stage I, II, or IIIa disease; patients to be treated in the pre-operative setting may be staged clinically but must have operable disease; both estrogen receptor negative and progesterone receptor negative tumors; bilateral synchronous invasive breast cancer diagnosed within 1 month of each other are eligible if both primary tumors hormone receptor negative; must be age 18 or greater and under age 50; planned treatment must include 3 to 6 months or cycles of an alkylating agent containing postoperative chemotherapy regimen anthracycline-based or non-anthracycline based; must not start planned chemotherapy prior to registration for S0230; must have modified radical mastectomy or local excision of all tumors plus axillary lymph node dissection and/or sentinel node resection prior to registration; all resection margins must be histologically negative for invasive cancer/ductal carcinoma in situ; resection margins positive for lobular carcinoma in situ eligible; must be registered within 84 days after final surgical procedure required to adequately treat primary tumor or axilla; not receive prior cytotoxic chemotherapy; must not have received estrogen, antiestrogens, selective estrogen receptor modulators, aromatase inhibitors, or hormonal forms of contraception within the past month with the following exceptions: (1)women under the age of 35 may have had recent use of oral contraceptive pills but these must be discontinued prior to randomization (2) for women of all ages, up to two months of hormonal treatments for oocyte collection for the purposes of in vitro fertilization and cryopreservation of embryos or oocytes is permitted provided these treatments are complete prior to randomization; women using oral contraceptive pills or hormonal treatments for oocyte collection during the month prior to enrollment must have documentation for FSH and estradiol levels in the premenopausal range; no prior malignancy except adequately treated basal cell/squamous cell skin cancer, in situ, cancer or disease-free for five years; PS=0-2 by Zubrod criteria; no pregnant or nursing women

1.0 Cancer Control Credit