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Clinical Trials/NCT06833502
NCT06833502RecruitingPhase 2

Phase II Study of Systemic Screening in Pathologic Node Positive Breast Cancer Following Neoadjuvant Chemotherapy and Surgery

H. Lee Moffitt Cancer Center and Research Institute1 site in 1 country120 target enrollmentStarted: February 24, 2025Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Phase 2
Status
Recruiting
Enrollment
120
Locations
1
Primary Endpoint
Systemic Metastasis
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Screening
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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 Guidelines
  • •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.
  • •Life expectancy ≥ 6 months.
  • •Eastern Cooperative Oncology Group performance status 0 to
  • •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).

Arms & Interventions

Triple negative

Other

Participants diagnosed with triple negative breast cancer.

Intervention: CT Scan (Other)

HER2+

Other

Participants diagnosed with HER2+ breast cancer.

Intervention: CT Scan (Other)

Hormone receptor (HR)+

Other

Participants diagnosed with hormone receptor (HR)+ breast cancer.

Intervention: CT Scan (Other)

Outcomes

Primary Outcomes

Systemic Metastasis

Time Frame: Baseline and 6 months

Proportion of participants with systemic metastasis at baseline and 6 months.

Secondary Outcomes

  • Metastasis Treatment(Up to 12 months)
  • Metastasis Frequency(Up to 12 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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