SWOG S0221: a phase III trial comparing chemotherapy schedules in high-risk early-stage breast cancer.

ABSTRACT:

Purpose

To determine the optimal dose and schedule of anthracycline and taxane administration as adjuvant therapy for early-stage breast cancer.

Patients and methods

A 2 × 2 factorial design was used to test two hypotheses: (1) that a novel continuous schedule of doxorubicin-cyclophosphamide was superior to six cycles of doxorubicin-cyclophosphamide once every 2 weeks and (2) that paclitaxel once per week was superior to six cycles of paclitaxel once every 2 weeks in patients with node-positive or high-risk node-negative early-stage breast cancer. With 3,250 patients, a disease-free survival (DFS) hazard ratio of 0.82 for each randomization could be detected with 90% power with two-sided α = .05. Overall survival (OS) was a secondary outcome.

Results

Interim analyses

SUBMITTER: Budd GT 

PROVIDER: S-EPMC4268253 | biostudies-literature | 2015 Jan

REPOSITORIES: biostudies-literature