Invasive Breast Carcinoma Clinical Trial
Official title:
An Investigator Initiated Registry of Simple Oral Therapy for Low Risk Breast Cancer (SOLR)
This pilot clinical trial studies how well endocrine therapy works in treating patients with HER2 negative, low risk breast cancer. Estrogen can cause the growth of breast cancer cells. Endocrine therapies such as aromatase inhibitors and selective estrogen receptor modulators may lessen the amount of estrogen made by the body.
PRIMARY OBJECTIVES:
I. To estimate the conversion rate from a standard low-toxicity approach to
guideline-directed therapy which includes surgery +/- radiation therapy as a result of
progression of disease or patient/provider choice.
II. To examine factors that might differ between those who convert from the low-toxicity
approach to the guideline-directed therapy and those do not convert.
SECONDARY OBJECTIVES:
I. To measure the safety and clinical effectiveness of systemic endocrine therapy used in a
prolonged neoadjuvant fashion.
II. To evaluate the impact of risk-stratified care in Quality-Adjusted Life Years (QALY) and
QALY gains.
III. To estimate the cost savings of indefinitely delaying surgery and radiation in favor of
systemic endocrine therapy alone.
OUTLINE:
Patients receive exemestane orally (PO) once daily (QD), anastrozole PO QD, letrozole PO QD,
tamoxifen citrate PO QD, or toremifene citrate PO QD at the discretion of the treating
physician. Treatment continues in the absence of disease progression or unacceptable
toxicity.
After completion of study treatment, patients are followed up periodically.
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