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EA1181


Title Preoperative THP and postoperative HP in patients who achieve a pathologic complete response
Therapeutic Area Breast Cancer
Principal Investigator Rachel Buchsbaum, MD
Min Age 18 Years
Gender Both
Contact NCCCR Staff
617-636-3264
NCCCR@tuftsmedicalcenter.org
More Information https://clinicaltrials.gov/ct2/show/NCT04266249?term=NCT04266249&draw=2&rank=1

Overview

The trials within CompassHER2 Program address clinical therapeutic objectives, as well as those that address translational questions, patient-reported outcomes, and outcomes measuring loco-regional recurrence. EA1181 is a single-arm trial.

Study Details

Inclusion Criteria

  1. Must have histologically confirmed HER2-postive primary invasive breast carcinoma.
  2. Must have clinical stage II and IIIa (T2-3/N0-2/M0) at diagnosis.
  3. Must not have history of any prior (ipsilateral or contralateral) invasive breast cancer

Exclusion Criteria

  1. Have stage IV (metastatic) breast cancer
  2. Have T4 and/or N3 disease, including inflammatory breast cancer
  3. Have any prior treatment for the current breast cancer, including surgery, chemotherapy, hormonal therapy, radiation or experimental therapy

Study Requirements

Listed below are exams, tests, and procedures that need to be done as part of this study to monitor your safety and health, but may not be included in the usual care. We will use them to carefully follow the effects of the study treatment, including preventing and managing side effects.

These exams, tests, and procedures to monitor your safety and health include:

  • Physical exam
  • Medical history
  • Vital signs
  • Pregnancy test, if you are a woman of child-bearing potential.

Some exams, tests, and procedures are a necessary part of the research study, but would not be included in usual care. Listed below are procedures that will be done for research purposes only.

Blood samples will be collected for research studies as described below. These research studies are required if you participate in this trial. The tests are for research purposes only and the results will not be given to you or your doctor and will not affect your care. The blood samples will be collected by using a needle to draw some blood from a vein in your arm. The most common risks related to drawing blood from your arm are brief pain and maybe a bruise, bleeding, or feeling faint.

Approximately four (4) teaspoons of blood will be collected at the following timepoints: before you start therapy; after 3 weeks of therapy; after 12 weeks of therapy are completed before surgery; after surgery before any further therapy is given; and after you complete all of your HER2-targeted therapy [e.g., Herceptin (trastuzumab) and Perjeta (pertuzumab)].

The blood samples will be sent to a research laboratory to learn about how the study treatment affects your cancer. Researchers will perform these tests in order to understand how well your tumor responds to the therapy you receive and whether it can indicate if your tumor will recur. These studies may help explain why some people respond to treatment and why others do not benefit.