Phase II Study of Systemic Screening in Pathologic Node Positive Breast Cancer
Phase II Study of Systemic Screening in Pathologic Node Positive Breast Cancer Following Neoadjuvant Chemotherapy and Surgery
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study looks at how often breast cancer has spread to other parts of the body after chemotherapy and surgery in people whose cancer is still in nearby lymph nodes. Participants have CT scans (detailed X-ray pictures) of the chest, belly, and pelvis before radiation treatment. The study lasts about 6 months, with another CT scan at 6 months if the first scan shows no spread.
The purpose of the study is to determine the frequency of systemic metastasis in node positive breast cancer following chemotherapy and surgery. Participants will be asked to spend about 6 months in this study. Participants will undergo a computed tomography (CT) screening of the thorax, abdomen, and pelvis at baseline prior to adjuvant radiation therapy and another CT screening of the thorax, abdomen, and pelvis at 6 months if the baseline CT is found to be negative.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be age 18 or older.
- Have breast cancer confirmed by a tissue test, with results for ER, PR, and HER2—markers used to group breast cancers.
- Have HER2-positive or triple-negative cancer still in lymph nodes after chemotherapy given before surgery. Hormone-positive, HER2-negative cancer must have more extensive lymph node disease, called ypN2 or ypN3, after chemotherapy and surgery.
- Have finished at least 8 weeks of standard chemotherapy before surgery, using an anthracycline, a taxane, or both. People with HER2-positive cancer must also have had HER2-targeted treatment.
- Be expected to live at least 6 months.
- Be able to care for yourself and be out of bed or a chair for more than half of your waking hours, even if you cannot work.
- Be able to understand the study and be willing to sign a consent form.
- Be willing and available to follow all study steps for the full study.
Who can't join
- Have previously been diagnosed with cancer that spread to distant parts of the body.
- Have had a cancer other than breast cancer and have not been free of that cancer for at least 2 years. This does not include adequately treated non-melanoma skin cancer or cancer limited to the lining of the cervix or bladder.
- Have a medical reason you cannot receive the contrast dye given through a vein for a CT scan.
- Have severe kidney disease: stage 4 or 5, end-stage kidney disease, or a kidney filtering rate below 30 mL/min.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * Histologic diagnosis of breast cancer with documentation of ER/PR/HER2 status. * HR+ will be defined as ER and/or PR ≥ 10%. To be classified as HER2+ disease, overexpression of HER2 by either IHC or in-situ hybridization is necessary as defined by the ASCO / CAP Guidelines27. Triple negative will be classified as ER and PR \<10% and HER2-. * Node positive HER2+ and triple negative breast cancer (ypN+) following receipt of neoadjuvant chemotherapy. HR+/HER2- patients should have ypN2 or ypN3 disease following receipt of neoadjuvant chemotherapy and surgery. * Patient must have completed a minimum of 8 weeks of standard neoadjuvant chemotherapy consisting of an anthracycline and/or taxane-based regimen. To include HER2 directed therapy for HER2+ patients. * Age ≥ 18. * Life expectancy ≥ 6 months. * Eastern Cooperative Oncology Group performance status 0 to 2. * Patients must be able to understand and the willingness to sign an informed consent for study procedures. * Ability to understand and stated willingness to comply with all study procedures and availability for the duration of the study. Exclusion Criteria: * Prior diagnosis of systemic metastases. * Patients with prior history of non-breast cancer malignancies should have NED ≥ 2 years excluding adequately treated non-melanoma skin cancer, in situ cancer of the cervix or bladder. * Contraindication towards CT IV contrast. * Chronic kidney disease stage IV or V or end stage renal disease (CrCl \<30 ml/min).
Study sites (1)
FL
- Moffitt Cancer Center · Tampa, FL 33612Kamran Ahmed, MD · Principal investigatorMatthew Mills, MD · Principal investigatorAvan Armaghani, MD · Sub-investigatorRicardo Costa, MD · Sub-investigatorMore trials in Tampa