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A Phase III Clinical Trial Evaluating De-Escalation of Breast Radiation for Conservative Treatment of Stage I, Hormone Sensitive, HER-2 Negative, Oncotype Recurrence Score Less Than or Equal to 18 Breast Cancer
Status: Recruiting
We are comparing treatment of early stage, hormone positive breast cancer with and without radiation therapy. One group will receive radiation therapy with endocrine therapy and the other group will receive endocrine therapy alone. We want to find out if there is any difference in how often breast cancer recurs in the same breast.
Sex: Male or Female
Age Group: 18 years and over
Inclusion Criteria:
• completed surgery to remove a breast tumor and there isn't any evidence of remaining tumor.
• Early stage (T1) tumor without lymph node involvement and a Oncotype DX Recurrence Score of less than or equal to 18
• ER and/or PgR positive and HER2 negative tumor
Exclusion Criteria:
• tumor size larger that T1
• surgical procedure was a mastectomy
• any treatment with radiation therapy, chemotherapy, biotherapy, and/or endocrine therapy given for the currently diagnosed breast cancer prior to study entry
• Women who are pregnant or breast feeding
Interventions:
Drug: Endocrine Therapy (Tamoxifen, Anastrozol, Letrozole, Exemestane), Other: Radiation and Endocrine Therapy (Tamoxifen, Anastrozol, Letrozole, Exemestane)
Conditions:
Cancer
Keywords:
Breast Cancer, Breast Cancer, Radiation, Stage 1 breast cancer. Hormone positive breast cancer
Study Contact: Kristen Nelson - knelso65@fairview.org
Principal Investigator: Jocelin Huang
Phase: PHASE3
IRB Number: MMCORC044
See this study on ClinicalTrials.gov