| Inclusion Criteria: | 1) Patients must be premenopausal women with a histologically confirmed diagnosis of operable Stage I, II, or 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. For the purposes of this study, premenopausal is defined as the presence of cyclic menstrual bleeding within 6 weeks prior to randomization or documentation of FSH and estradiol levels in the premenopausal range.
2) Patients must have tumors that are both estrogen receptor negative and progesterone receptor negative. Tumors with > 10% cells staining positive for either ER and/or PR on immunohistochemistry assay will be considered receptor POSITIVE. Tumors with > 3 fm/mg cytosol protein on ligand-binding or EIA assay will be considered receptor POSITIVE. Patients with bilateral synchronous invasive breast cancer diagnosed within 1 month of each other are eligible only if both primary tumors are hormone receptor negative.
3) Patients must be of age 18 or greater and under age 50.
4) The patient's planned treatment must include 3 to 8 months or cycles of an alkylating agent containing postoperative chemotherapy regimen that can be anthracycline-based or non-anthracycline-based. Patients can concurrently participate in other therapeutic trials. Patients must not start the planned chemotherapy prior to registration to S0230.
5) All patients must have had either a modified radical mastectomy or local excision of all tumors plus an axillary lymph node dissection and/or sentinel node resection prior to registration. All resection margins must be histologically negative for invasive cancer and ductal carcinoma in situ. Patients with resection margins positive for lobular carcinoma in situ will be eligible. For patients receiving chemotherapy in the pre-operative setting, there must be no intention to give additional chemotherapy in the postoperative setting (i.e., all chemotherapy should be completed prior to surgery).
6) Patients receiving post-operative chemotherapy must be registered within 84 days after the final surgical procedure required to adequately treat the primary tumor or axilla.
7) Patients must not have received prior cytotoxic chemotherapy for this breast cancer or for any condition.
8) Patients must not have received estrogens, antiestrogens, selective estrogen receptor modulators, aromatase inhibitors, or hormonal forms of contraception within the past month with the following exceptions: Women under the age of 35 may have had recent use of oral contraceptive pills but these must be discontinued prior to randomization. In addition, 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 (continued under inclusion criteria # 9)
9) (continuation from # 8) 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 of FSH and estradiol levels in the premenopausal range.
10) No prior malignancy is allowed except for adequately treated basal cell (or squamous cell) skin cancer, in situ cancer or other cancer for which the patient has been disease-free for five years after treatment with curative intent.
11) Patients must have a performance status of 0 - 2 by Zubrod criteria.
12) Pregnant or nursing women may not participate due to the possibility of fetal harm or of harm to nursing infants from this treatment regimen. Women of reproductive potential must agree to use an effective barrier contraceptive method.
13) If Day 84 falls on a weekend or holiday, the limit may be extended to the next working day.
14) All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.
15) At the time of patient registration, the treating insitution's name and ID number must be provided to the Statistical Center in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered into the data base. |