Phase II Study of Systemic Screening in Pathologic Node Positive Breast Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorH. Lee Moffitt Cancer Center and Research Institute
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
CT Scan
Other interventionParticipants 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.
Treatment groups
120 Participants
are divided into 3 treatment groupsGroup A: Triple negativeOther 1 intervention
Group B: HER2+Other 1 intervention
Group C: Hormone receptor (HR)+Other 1 intervention
Trial outcomes
Primary outcomes
1
Systemic Metastasis
Proportion of participants with systemic metastasis at baseline and 6 months.
Time frame
Baseline and 6 monthsSecondary outcomes
1
Metastasis Treatment
Number of patients receiving surgery, radiation therapy, and/or systemic therapy to manage metastases.
Time frame
Up to 12 months2
Metastasis Frequency
Proportion of participants with metastasis up to 12 months from baseline CT.
Time frame
Up to 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
H. Lee Moffitt Cancer Center and Research Institute
Lead sponsor
Florida Breast Cancer Foundation
Collaborator
Source ClinicalTrials.gov