Effect of Preoperative Chemotherapy on Axillary Lymph Node Metastases in Stage II Breast Cancer: A Prospective Randomized Trial

Launched by NATIONAL CANCER INSTITUTE (NCI) · Nov 3, 1999

Keywords

ClinConnect Summary

A prospective randomized trial evaluating the effect of preoperative dose intense chemotherapy (FLAC/G-CSF) on axillary lymph node metastases in women with clinical stage II (T1N1, T2N0, T2N1) breast cancer. Patients will be randomized to receive 5 cycles of combination chemotherapy (5-FU, adriamycin, leucovorin, cytoxan, G-CSF) either as initial therapy (preoperative) or postoperatively after local therapy (modified radical mastectomy or lumpectomy/axillary lymph node dissection/whole breast radiotherapy). Each chemotherapy cycle will be 21 days. At the time of local therapy the incidence ...

Gender

FEMALE

Eligibility criteria

• • INCLUSION CRITERIA
• Women of any age with clinical stage II breast cancer who met the following criteria:
• • Patients with stage II breast cancer will include primary tumor less than or equal to 5 cm in size with axillary lymph nodes which are clinically (\[N0 or N1\] \[T1N1, T2N0, T2N1\]).
• • Patients will be staged according to the 1986 AJCC TMM classification.
• • Patients with bilateral breast cancer will be eligible provided at least one tumor is invasive and classified as stage I or II, and neither breast is stage III.
• • Histologic sections of the breast tumor must be classified as an invasive primary breast neoplasm of epithelial origin.
• • Patients must be geographically accessible for follow-up and willing to return for the follow-up at the NCI.
• • Patients must be mentally competent to understand and give informed consent for the protocol.
• • Estrogen receptor (ER) status can include ER positive, negative, or unknown.
• • Patients with prior cancers may be eligible as long as they have received curative therapy and have had no evidence of recurrence for greater than or equal to 10 years.
• • EXCLUSION CRITERIA
• Patients will be excluded from this protocol for the following reasons:
• • Advanced local disease or distant metastases (stage III or IV).
• • Previous therapy to the breast other than excisional biopsy.
• • Pregnancy.
• • Unwillingness to use birth control during chemotherapy.
• • Chronic disease such as heart, lung, liver, kidney, blood or metabolic disorders which may render the patient a poor risk for surgery or chemotherapy. Specifically, liver function - SGOT, SGPT, alkaline phosphatase and total bilirubin should be less than 1.5 x the upper limits of normal. Renal function - creatinine should be less than 1.7 and/or creatinine clearance should be greater than 45 ml/min. If there is any history of cardiac disease, patients must have a normal ejection fraction on MUGA scan and no angina.