ECOG-ACRIN EA1181

Clinical Trial Title Preoperative THP and postoperative HP in patients who achieve a pathologic complete response (CompassHER2 pCR)
Trial Status Open to Enrollment
Start Date 09/22/2022
Location hospitals
Trial Type Cancer - Adult Oncology
Specific Condition Breast Cancer
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.
Eligibility Criteria

Eligibility Criteria

  • Patient must be ≥ 18 years of age.
  • Patients must have an ECOG performance status of 0 or 1.
  • Patient must have histologically confirmed HER2-positive primary invasive breast carcinoma, determined by local testing.
  • Patients hormone receptor (ER and PR) status must be known and will be determined by local testing. Patients with either hormone receptor–positive or hormone receptor- negative HER2-positive breast cancer are eligible.
  • Patient must not have a history of any prior (ipsilateral or contralateral) invasive breast cancer.
  • Patients currently receiving endocrine therapy for prior contralateral DCIS are eligible.
  • Patient must not have any prior treatment for the current breast cancer, including surgery, chemotherapy, hormonal therapy, radiation or experimental therapy.

Please contact Legacy Oncology Research for additional study inclusion/exclusion information.
IRB Number Central IRB
Notes CompassHER2-pCR: Decreasing Chemotherapy for Breast Cancer Patients After Pre-surgery Chemo and Targeted Therapy - Full Text View - ClinicalTrials.gov
Principal Investigator Onyekachi Ogbonna, MD
Contact Name Oncology Clinical Research
Contact Phone 503-413-8199
Contact Fax 503-413-6920
Contact E-Mail oncologyresearch@lhs.org