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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02171078
Enrollment
34359
Registered
2014-06-23
Start date
2014-06-30
Completion date
2017-12-31
Last updated
2022-12-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Neoplasms

Keywords

Breast Cancer, Breast Neoplasms, Health Services Research, Surveillance, Diagnostic Imaging, Magnetic Resonance Imaging, Mammography, Toxicity, Adverse Effects, Side Effects, Recurrence

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.

Interventions

None listed

Sponsors

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

Study design

Observational model
OTHER
Time perspective
OTHER

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Time to Recurrence5 Years from DiagnosisData 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 TreatmentWithin relevant timeframe of legacy clinical trial. Most trials include 2-year follow-upLegacy 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

MeasureTime frame
Time to DeathWithin 5 years from time of diagnosis

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026