This trial is active, not recruiting.

Condition breast neoplasms
Sponsor University of Wisconsin, Madison
Collaborator Patient-Centered Outcomes Research Institute
Start date June 2014
End date February 2017
Trial size 50881 participants
Trial identifier NCT02171078, 2014-0742, CE-1304-6543, UW14041


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.

United States No locations recruiting
Other countries No locations recruiting

Primary Outcomes

Time to Recurrence
time frame: 5 Years from Diagnosis
Time to Toxicity/Side Effects of Treatment
time frame: Within relevant timeframe of legacy clinical trial. Most trials include 2-year follow-up

Secondary Outcomes

Time to Death
time frame: Within 5 years from time of diagnosis

Eligibility Criteria

Female participants of any age.

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

    Additional Information

    Official title Post-Treatment Surveillance in Breast Cancer: Bringing CER to the Alliance
    Principal investigator Caprice C Greenberg, MD MPH
    Description Our project involves three primary goals: 1. 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. 2. Use existing data to evaluate the effectiveness of the latest imaging technology for improving survival in patients previously treated for breast cancer. 3. 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.
    Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
    Information provided to ClinicalTrials.gov by University of Wisconsin, Madison.