Protocol Title

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

Description

The main purpose of the study is to learn whether or not continuing hormonal therapy with an aromatase inhibitor (AI) called letrozole for 5 additional years after already taking 5 years of hormonal therapy can further reduce the chance of breast cancer returning. The initial 5 years of hormonal therapy must have included an AI for at least 2 years. Letrozole is investigational (still being researched) for use in patients who have already received an AI as part of their 5 years of hormonal therapy. Another reason for doing this study is to find out whether or not taking the drug letrozole after taking 5 years of hormonal therapy that included an AI causes more thinning of your bones (osteoporosis) which can cause your bones to break more easily. We also want to find out if letrozole increases the chance of heart attack, stroke, and other problems with blood vessels called arteries.

Participants will be randomized into one of two treatment groups. Participants in Group 1 will take a placebo by mouth every day for 5 years. The placebo is a tablet that looks like the letrozole tablet but does not contain any active drug. Participants in Group 2 will take a letrozole tablet by mouth every day for 5 years.

Objectives

To determine whether or not prolonging adjuvant hormonal therapy with letrozole will improve disease-free survival in post-menopausal women with ER-positive and/or PgR-positive tumors who have completed 5 years of hormonal therapy.

To determine whether or not prolonged hormonal therapy with letrozole will decrease the rate of breast cancer recurrence.

Eligibility

Patient must be a post-menopausal female.

Patient must have been stage I, II or IIIA and must have undergone either a lumpectomy followed by radiotherapy or total mastectomy.

Patient’s primary tumor must have been ER-positive and/or PgR-positive.

Patient must have completed either 5 years of an aromatase inhibitor or up to 3 years of Tamoxifen followed by an aromatase inhibitor (for a total of 5 years).

Contact

For the current eligibility status of and additional information about this clinical study, please contact Breastlink Clinical Research Group at 1-562-981-6101.

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