Phase II Study of Systemic Screening in Pathologic Node Positive Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CT Scan.
- Who it may be relevant to
- Registry conditions: Breast Cancer, Node-positive Breast Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Phase II Study of Systemic Screening in Pathologic Node Positive Breast Cancer Following Neoadjuvant Chemotherapy and Surgery
Overview
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.
Interventions
- Other CT Scan
Participants will undergo a screening CT thorax, abdomen, pelvis at baseline prior to adjuvant radiation therapy and additional screening CT thorax, abdomen, and pelvis at 6 months if the baseline CT is found to be negative.
Primary outcome measures
- Systemic Metastasis [Time frame: Baseline and 6 months]
Secondary outcome measures (2)
- Metastasis Treatment [Time frame: Up to 12 months]
- Metastasis Frequency [Time frame: Up to 12 months]
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Screening
Study locations
United States · 1 center
- Moffitt Cancer Center — Tampa
Identifiers
NCT: NCT06833502 · MCC-23433