PHASE III Standard Adjuvant Endocrine Therapy with or without Chemotherapy in Patients with One to Three Positive Nodes, Hormone Receptor-Positive and HER2-Negative Breast Cancer with Recurrence Score of 25 or Less
The purpose of this study is to find out if the Oncotype DX Recurrence Score can help decide whether patients should receive chemotherapy or not. This study is being done in patients with lower Recurrence Scores (25 or less).
If the results of this study show there is a benefit for getting chemotherapy is dependent on the Recurrence Score, the study may be able to identify a Recurrence Score level where chemotherapy may or may not be needed.
Eligibility criteria include the following:
- A histologically confirmed diagnosis of node positive (1-3 nodes) invasive breast cancer with positive estrogen and/or progesterone receptor status, and negative HER2.
- Multifocal, multicentric and synchronous bilateral breast cancers are allowed
- No inflammatory breast cancer
- May have had either breast-conserving surgery or total mastectomy
- For those who have not undergone Oncotype DX screening, patients must be willing to submit tissue samples for testing
- For those who have had Oncotype DX testing, the recurrence score must < 25
- Must not have started chemotherapy or endocrine therapy for their breast cancer prior to registration into the study
- Must not have received preventive tamoxifen or raloxifene
- Must be female
- Must be at least 18 years of age
- Must not be receiving chronic treatment with systemic steroids or other immunosuppressive drugs
- Must not be pregnant or nursing
- Women of reproductive potential must agree to use effective contraception
- Must not have prior malignancy
- Registration/Randomization must take place within 84 days of surgery
Final eligibility for a clinical trial is determined by the health professionals conducting the trial.
Patients will be randomly assigned to one of two groups:
- Endocrine therapy
- Endocrine therapy
- Radiation is recommended for patients that have had breast conserving surgery and may be given before or during endocrine therapy
Follow-up visits occur every three months for the first two years, then every six months for the next three years. After five years, one follow-up visit per year is required for at least 15 years after starting the study. During treatment, patients are followed more frequently based on protocol requirements.