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SWOG S1007

Phase III Randomized Study of Standard Adjuvant Endocrine Therapy With Versus Without Chemotherapy in Patients With 1-3 Positive Nodes, Hormone Receptor-Positive, and HER2-Negative Breast Cancer

Trial Description

Purpose:

Estrogen can cause the growth of breast cancer cells. Hormone therapy, usingtamoxifen citrate, may fight breast cancer by blocking the use of estrogen by the tumor cells. Aromatase inhibitors, such as anastrozole, letrozole, and exemestane, may fight breast cancer by lowering the amount of estrogen the body makes.Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving tamoxifen citrate, anastrozole, letrozole, or exemestane is more effective with combination chemotherapyin treating patients with breast cancer.

This phase III clinical trialis studying how well giving tamoxifen citrate, anastrozole, letrozole, or exemestane with or without chemotherapy works in treating patients with invasive breast cancer.

Eligibility:

Eligibility criteriainclude the following:

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will be randomly assigned (have an equal chance of being placed) to one of two treatment groups.

Patients in group one will receive an approved chemotherapyregimen based on the patient and/or doctor preference. Patients will then receive an approved hormonal therapy (tamoxifen citrate, anastrozole, letrozole, or exemestane or tamoxifen citrate together with anastrozole, letrozole, or exemestane) for 5-10 years.

Patients in group two will receive an approved hormonal therapy (tamoxifen citrate, anastrozole, letrozole, or exemestane or tamoxifen citrate together with anastrozole, letrozole, or exemestane) for 5-10 years.

Patients may complete questionnaires at baseline and periodically during treatment. Information about health insurance coverage may also be collected.

After finishing treatment, patients will be evaluated every 3 months for 2 years, every 6 months for 3 years, and then once a year for up to 15 years.

Trial Contact Information

Blanche Reiner RN OCN 610-738-2515

Nona Blauvelt MSN AOCN 610-738-2522

Last Updated: 6/11/2012