Clinical Trial TitleDe-Escalation of Breast Radiation Trial for Hormone Sensitive, HER-2 Negative, Oncotype Recurrence Score Less Than or Equal to 18 Breast Cancer (DEBRA)
National Clinical Trial Number:NCT04852887
Clinical Trial Protocol Description:
This Phase III Trial evaluates whether breast conservation surgery and endocrine therapy results in a non-inferior rate of invasive or non-invasive ipsilateral breast tumor recurrence (IBTR) compared to breast conservation with breast radiation and endocrine therapy.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Provide study-specific informed consent prior to study entry and, for patients treated in the U.S., authorization permitting release of personal health information.
- By pathologic evaluation, ipsilateral nodes must be pN0.
- Have undergone a lumpectomy.
- Have a tumor that is unilateral invasive adenocarcinoma.
You will be excluded from the study if any of the following criteria apply to you:
- Have definitive clinical or radiologic evidence of metastatic disease.
- Have had a mastectomy..
- Have had short course endocrine therapy of less than 6 weeks duration is acceptable post core biopsy pre surgery if the Oncotype DX Recurrence Score is assessed on the biopsy core and is less than or equal to 18.
This is a partial list of eligibility requirements. To inquire about your eligibility, please call the contact number provided. If you wish to inquire via email, please include the title of the study in your message.