Clinical Trial TitleAssessing the accuracy of tumor biopsies after chemotherapy to determine if patients can avoid breast surgery.
Clinical Trial Protocol Description:
The purpose of this study is to look at tumor tissue collected from a biopsy done before breast surgery to check if the chemotherapy that patients received destroyed their breast cancer cells. The researchers want to learn if it is safe to avoid breast cancer surgery if there are no cancer cells in the tumor sample from the biopsy. In this study, the results of the tumor sample from the biopsy before or on the day of surgery will be compared to the results of the tumor that is removed during surgery to see if they are the same. If cancer cells are not seen in both the tumor sample from the biopsy and in the tumor removed during surgery, the researchers will use this information to decide if patients who have breast cancer in the future can avoid surgery by using the results of a biopsy.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Are male or female and 18 years of age or older with ER analysis and HER2 testing prior to neoadjuvant therapy.
- Have operable focal or multifocal (T1-T3, stage II and IIIA invasive ductal carcinoma [all receptor phenotypes]), and have completed neoadjuvant chemotherapy with a clinical complete response.
- Have completed a minimum of 8 weeks of standard neoadjuvant chemotherapy consisting of an anthracycline and/or taxane-based regimen.
- Have achieved a complete or near complete radiologic tumor response on breast imaging with mammogram, ultrasound, and MRI.
You will be excluded from the study if any of the following criteria apply to you:
- Have T4 tumors (including inflammatory breast cancer).
- Have metastatic disease, history of prior radiation therapy, invasive lobular carcinoma, or have been treated with prior neoadjuvant hormonal therapy.
- Have had lumpectomy prior to study entry.
This is a partial list of inclusion and exclusion criteria.