CALGB 8541 — Dose and Dose Intensity of Adjuvant Chemotherapy for Stage II, Node-Positive Breast Carcinoma

Phase III · 1994 · Breast Cancer

Design

Randomized phase III trial comparing three dose/dose-intensity levels (high, moderate, low) of adjuvant cyclophosphamide, doxorubicin, and fluorouracil (CAF) in women with node-positive breast cancer.

Population

Women with stage II, node-positive, operable breast carcinoma (1,572 patients) following primary surgery.

Primary Endpoint

Disease-free survival and overall survival

Key Result

Both DFS and OS were superior in the high- and moderate-dose CAF arms versus the low-dose arm (5-year DFS 66% and 61% vs 56%; OS 79% and 77% vs 72%; P=0.001 for DFS trend), demonstrating a dose-intensity threshold effect.

Guideline Impact

Defined dose-intensity thresholds for adjuvant breast cancer chemotherapy