Post-Treatment Surveillance in Breast Cancer: Bringing CER to the Alliance
- Conditions
- Breast Neoplasms
- Registration Number
- NCT02171078
- Lead Sponsor
- University of Wisconsin, Madison
- Brief Summary
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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 34359
- 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)
- None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to Recurrence 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.
Time to Toxicity/Side Effects of Treatment 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 Outcome Measures
Name Time Method Time to Death Within 5 years from time of diagnosis
Trial Locations
- Locations (1)
University of Wisconsin-Madison School of Medicine and Public Health
🇺🇸Madison, Wisconsin, United States