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Testing the Role of FDG-PET/CT to Predict Response to Therapy Prior to Surgery for HER2-positive Breast Cancer, The DIRECT Trial

EA1211, Interim FDG-PET/CT for PreDIcting REsponse of HER2+ Breast Cancer to Neoadjuvant Therapy: DIRECT trial

Breast cancer
All genders
person-wave 18+
Recruiting now
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Principal Investigator: Rachel Buchsbaum, MD

This phase II trial tests how well an imaging procedure called fludeoxyglucose F-18 (FDG) positron emission tomography/computed tomography (PET/CT) works in predicting response to standard of care chemotherapy prior to surgery in patients with HER2-positive stage IIa-IIIc breast cancer. FDG is a radioactive tracer that is given in a vein before PET/CT imaging and helps to identify areas of active cancer. PET and CT are imaging techniques that make detailed, computerized pictures of areas inside the body. The use of FDG-PET/CT may help doctors better decide if a patient needs more or less treatment before surgery in order to get the best response. This study evaluates whether FDG-PET/CT is useful in predicting a patient's response to standard of care chemotherapy.

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Latoya Lashley

Study details

Inclusion Criteria
  • 1. Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
  • 2. Patient must have histologically confirmed HER2-positive primary invasive breast carcinoma by American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines that has been determined by local testing.
  • 3. Patient must have known (either positive or negative) hormone receptor (estrogen receptor [ER] or progesterone receptor [PR]) status by local testing, per ASCO/CAP guidelines. Patients with either hormone receptor-positive or hormone receptor- negative HER2-positive breast cancer are eligible.
Exclusion Criteria
  • 1. Patient must not have any prior treatment for the current breast cancer, including surgery, chemotherapy, hormonal therapy, radiation or experimental therapy.
  • 2. Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the teratogenic effects of FDG in addition to the radiation exposure during PET/CT.
  • 3. Patient must not have any contraindication to FDG-PET/CT imaging which includes routine glucose values > 200 mg/dL and severe claustrophobia.
Study Requirements

Patients receive FDG intravenously (IV), undergo PET/CT, receive standard of care chemotherapy, and undergo standard of care surgery on study. Patients will undergo FDG-PET/CT imaging at baseline (T0) and on Day 15 (+7 days) of Cycle 1 (T1) of the selected neoadjuvant pertuzumab-based systemic regimen. Your doctor may ask you to fast for 4-6 hours before the FDG-PET/CT scan is done. Approximately 2-3 weeks after starting neoadjuvant treatment, you will complete a second FDG-PET/CT scan. After you finish the two study FDG-PET/CT scans, you will continue your course of treatment and your doctor will continue to follow you for at least 3 years on the study.

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