NSABP B-42

A Clinical Trial to Determine the Efficacy of Five Years of Letrozole Compared to Placebo in Patients Completing Five Years of Hormonal Therapy Consisting of an Aromatase Inhibitor (AI) or Tamoxifen Followed by an AI in Prolonging Disease-Free Survival in Postmenopausal Women with Hormone Receptor Positive Breast Cancer

Principal Investigator

Eleftherios Mamounas, MD MPH

Status

Disease Site

Breast [BR] Breast

Phase

III

Developmental Therapeutics

No

Primary Objective

To determine whether or not prolonged adjuvant hormonal therapy with letrozole will improve disease-free survival in postmenopausal women with ER-positive and/or PgR-positive tumors who have completed 5 years of hormonal therapy with 5 years of an aromatase inhibitor (AI) or 5 years of a combination of up to 3 years of tamoxifen followed by an AI.

Patient Population

Postmenopausal women with ER-positive and/or PgR-positive breast cancer who have completed 5 years of hormonal therapy with either 5 years of an aromatase inhibitor (AI) or up to 3 years of tamoxifen followed by an AI

Target Accrual

3840