Clinical Trial TitleEA1181: Preoperative THP and postoperative HP in patients who achieve a pathologic complete response (CompassHER2-pCR).
National Clinical Trial Number:NCT04266249
Clinical Trial Protocol Description:
This trial studies how well paclitaxel, trastuzumab, and pertuzumab work in eliminating further chemotherapy after surgery in patients with HER2-positive stage II-IIIa breast cancer who have no cancer remaining at surgery (either in the breast or underarm lymph nodes) after pre-operative chemotherapy and HER2-targeted therapy. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Trastuzumab and pertuzumab are both a form of "targeted therapy" because they work by attaching themselves to specific molecules (receptors) on the surface of tumor cells, known as HER2 receptors. When these drugs attach to HER2 receptors, the signals that tell the cells to grow are blocked and the tumor cell may be marked for destruction by the body's immune system. Giving paclitaxel, trastuzumab, and pertuzumab may enable fewer chemotherapy drugs to be given without compromising patient outcomes compared to the usual treatment.
Clinical Trial Eligibility Criteria:
In order to participate you must meet the following criteria:
- Have histologically confirmed HER2-positive primary invasive breast carcinoma.
- Have clinical stage II and IIIa (T2-3/N0-2/M0) at diagnosis.
- Have a known hormone receptor (estrogen receptor [ER] and progesterone receptor [PR]) status and will be determined by local testing. Patients with either hormone receptor -positive or hormone receptor- negative HER2-positive breast cancer are eligible.
- Are willing and able (i.e., have no contraindication) to receive standard adjuvant therapy, consisting of HER2-directed therapy, radiation (if indicated) and endocrine therapy (if ER+) if achieving pCR at surgery.
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.
Clinical Trial Investigator
RUSH University Medical Center
1620 W Harrison St
Chicago, IL 60612