Clinical Trial 23433

• Overview

  Study Title:

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

  Objective:

  To determine the frequency of asymptomatic systemic metastasis in high-risk node positive breast cancer following neoadjuvant chemotherapy and surgery by subtype. Determine the presentation and treatment characteristics of asymptomatic systemic metastases in metastatic breast cancer by subtype following definitive neoadjuvant chemotherapy and surgery by subtype. To determine progression free survival in asymptomatic systemic metastases in metastatic breast cancer by subtype following treatment. Assess outcomes of locoregional radiation therapy and to sites of oligometastases (1-5 sites) as appropriate using criteria from NRG-BR002 (Appendix A). Determine number of patients with metastases detected by standard of care imaging completed 12 months from baseline CT. Assess quality of life from CT screening. Assess adverse events because of CT screening. To quantify ctDNA and blood biomarkers in high-risk node positive breast cancer following neoadjuvant chemotherapy and surgery and its association to metastatic disease.

• Inclusion Criteria

  Key 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 > 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.
  • Other inclusion criteria may apply.

• Exclusion Criteria

  Key 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 > Other exclusion criteria may apply.

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