Tamoxifen Citrate or Aromatase Inhibitor in Treating Elderly Patients with Estrogen Receptor Positive Breast Cancer That Can Be Removed by Surgery

PRIMARY OBJECTIVES:

I. To correlate response to neoadjuvant endocrine treatment at 6 months with Oncotype DX Recurrence Score in women with early-stage estrogen receptor (ER)+ breast cancer who are 70 or older.

SECONDARY OBJECTIVES:

I. To determine the breast cancer-specific survival of women with early-stage ER+ breast cancer who are 70 or older who are treated with endocrine therapy alone.

II. To determine the rate of overall survival of women with early-stage ER+ breast cancer who are 70 or older who are treated with endocrine therapy alone.

EXPLORATORY OBJECTIVES:

I. To evaluate the molecular characteristics of breast cancers of women with early-stage ER+ breast cancer who are 70 or older who do respond to primary endocrine therapy versus those who do not.

II. To evaluate cost-effectiveness of treating women with early-stage ER+ breast cancer who are 70 or older with endocrine therapy alone.

III. To track the ER score (by reverse transcription [RT]-polymerase chain reaction [PCR], within the Recurrence Score) and response of women with early-stage ER+ breast cancer who are 70 or older who are treated with endocrine therapy alone.

IV. To track the quality of life (by Functional Assessment of Cancer Therapy-Breast [FACT-B]) of women with early-stage ER+ breast cancer who are 70 or older who are treated with endocrine therapy alone.

OUTLINE:

Patients receive tamoxifen citrate or aromatase inhibitors as directed by the package insert at the discretion of the treating physician for up to 5 years in the absence of disease progression or unacceptable toxicity. Patients who progress receive recommended standard care.

After completion of study treatment, patients are followed up every year for 5 years and at 10 years.