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Completed

NCT Number: NCT02171078

Post-Treatment Surveillance in Breast Cancer: Bringing CER to the Alliance

Nearly three million living women have survived breast cancer. Physicians rely on clinical practice guidelines to make decisions on follow-up care. Among other things, the goal is to monitor for recurrence or side effects of treatment among survivors. It is unclear whether these guidelines represent the best approach for any given patient as they do not account for differences in disease or patient preferences and may not consider recent advances in imaging and treatment options. We seek to develop a new approach to surveillance following breast cancer treatment which will be more patient-centered and effective than the existing one-size-fits-all approach and will consider individual risk factors.

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Key information

Conditions

Breast Neoplasms Breast Diseases Disease Attributes Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Skin Diseases Skin and Connective Tissue Diseases

Sex eligibility

Female

Study type

Observational

Primary location

University of Wisconsin-Madison School of Medicine and Public Health

Madison, Wisconsin, 53792, United States

About this study

Our project involves three primary goals:

  • Use existing data from clinical trials sponsored by one of the leading cancer cooperative groups to evaluate how risk of recurrence and side effects of treatment vary based on patient and cancer characteristics.
  • Use existing data to evaluate the effectiveness of the latest imaging technology for improving survival in patients previously treated for breast cancer.
  • Engage cancer survivors, providers, and health outcomes researchers in the development of an improved patient-centered approach to guide post-treatment care, as well as identification of the highest priority strategies for prospective randomized trials.

Methods Our methods have been developed based on input from patients and other stakeholders who identified the need for a large-scale observational study. The goal is to produce timely results, and guide the development of an improved approach to surveillance that recognizes individual patient risk factors and allows for design of future prospective studies. This study analyzes recurrence data and treatment side effects on over 22,000 patients involved in past clinical trials on breast cancer care. The project also involves the analysis of existing data (n=15,000 patients) from a national cancer registry (National Cancer Database) to evaluate whether new imaging technology, beyond mammography, are able to detect recurrence earlier and improve survival. Finally, we will engage cancer survivors, health care providers, and researchers to develop new guidance for the care and monitoring of breast cancer survivors, and to guide and prioritize future prospective trials.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women (all Aims)
  • Diagnosis of breast cancer (Aims 1 & 2)
  • American Joint Committee on Cancer (AJCC) stages I-III (Aim 1) AJCC stages II-III (Aim 2)
  • Patient, health care provider, and researcher stakeholders (Aim 3)

Exclusion criteria

  • None

Treatment and study plan

Primary outcomes

  1. Time to Recurrence

    Time frame: 5 Years from Diagnosis

    Data elements include the date and site of recurrence, type of recurrence (e.g., local/regional or distant recurrence), and progression.

  2. Time to Toxicity/Side Effects of Treatment

    Time frame: Within relevant timeframe of legacy clinical trial. Most trials include 2-year follow-up

    Legacy clinical trials contain detailed data on treatment toxicity and complications. Most trials include 2-year follow-up to determine the prevalence and time to presentation for each of the following toxicities: lymphedema, cardiotoxicity, and pneumonitis

    Safety Issue?:

    No

Secondary outcomes

  1. Time to Death

    Time frame: Within 5 years from time of diagnosis

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • Alliance for Clinical Trials in Oncology
  • American College of Surgeons
  • Dana-Farber Cancer Institute
  • Harvard University
  • M.D. Anderson Cancer Center
  • Patient-Centered Outcomes Research Institute
  • University of North Carolina, Chapel Hill

Registry information

Official study title

Post-Treatment Surveillance in Breast Cancer: Bringing Cost Effectiveness Research (CER) to the Alliance

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jun 23, 2014
Registry last updated
Dec 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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