Clinical Trial 23366

• Overview

  Study Title:

  Patient-Reported Outcomes in Recipients of Intralesional Vaccines for Breast Cancer at Moffitt Cancer Center

  Objective:

  SPECIFIC AIMS Aims: The goal of this study is to collect prospective patient reported outcomes (PROs) among patients receiving dendritic cell vaccines in the neoadjuvant, palliative, or future treatment settings using EORTC survey models including QLQ-BR 23, QLQ-C30 scoring systems within related breast oncology clinical trials at Moffitt Cancer Center (MCC). 1.1. Primary Objectives and Endpoints: 1.1.1. Primary Objective 1: To measure breast cancer symptoms and three domains of functioning using the quality-of-life questionnaire for breast cancer, QLQ-BR-23, at the beginning of treatment, midpoint, and end of all planned dendritic cell (DC) vaccine treatments among patients receiving dendritic cell (DC) vaccines in the neoadjuvant setting. 1.1.2. Primary Endpoint 1: Evaluate changes in breast cancer symptom and functional scores from start of treatment to midpoint and start of treatment to the end of all planned DC vaccine treatments. 1.1.3. Primary Objective 2: To measure overall quality of life during vaccine treatment using the QLQ-C30, at the beginning of treatment, midpoint, and end of all planned vaccine treatment among patients receiving DC vaccines in the neoadjuvant setting. 1.1.4. Primary Endpoint 2: Evaluate changes in symptoms, functional scores, and global health scores from start of treatment to midpoint and start of treatment to the end of all planned DC vaccine treatments.

• Inclusion Criteria

  Key Inclusion Criteria
  • Patients able to participate will have been successfully enrolled into on-going breast oncology clinical trials for intralesional vaccine administration at Moffitt Cancer Center.
  • Patients able to participate must complete at least 1 intralesional vaccine treatment dose.
  • Other criteria may apply.

• Exclusion Criteria

  Key Exclusion Criteria
  • Patients who do not meet inclusion criteria for on-going intralesional vaccine related clinical trials.
  • Patients who are not willing to complete the survey assessments required to participate in a PROs study.
  • Previous history of dendritic cell vaccine or other intralesional vaccine treatment for breast cancer.
  • Other criteria may apply.

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