Trial Information

Correlative Studies of ERBB-2/HER-2/NEU and p53 in CALGB Protocol 9344/INT Protocol 0148: "Doxorubicin Dose Escalation, With or Without Taxol®, as Part of the CA Adjuvant Chemotherapy Regimen For Node Positive Breast Cancer: A Phase III Intergroup Study

OBJECTIVES:

- Correlate erbB-2 (HER-2/neu) amplification and/or overexpression with additional or
less benefit derived from increasing doses of doxorubicin or addition of paclitaxel in
women with node-positive breast cancer, in terms of disease-free and overall survival.

- Correlate abnormalities in p53 (mutations, deletions, protein stabilization) with
additional or less benefit (in terms of disease-free and overall survival) in patients
treated with these regimens.

- Compare methods of assaying for erbB-2 (HER-2/neu) and p53 to determine whether one
method is more predictive of clinical outcome in these patients than the other.

OUTLINE: Formalin-fixed, paraffin-embedded tissue blocks are analyzed for amplification
and/or overexpression of erbB-2 (HER-2/neu) and for mutations or deletions of p53 by
fluorescent in situ hybridization (FISH) and immunohistochemistry.

PROJECTED ACCRUAL: Samples will be collected from a total of 600 patients.