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

University of Wisconsin (UW)

Status: Completed

Conditions: Breast Neoplasms

Study type: Observational

Funder types: Other

Identifiers

NCT02171078

2014-0742

CE-1304-6543 (Other Grant/Funding Number)

SMPH/SURGERY/SURG ONC (Other Identifier)

A539713 (Other Identifier)

UW14041 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 34,359 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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

Trial design

34,359 participants in 3 patient groups

Alliance for Clinical Trials Database

Description:

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.

National Cancer Database

Description:

Use existing data to evaluate the effectiveness of the latest imaging technology for detecting recurrence and improving survival in patients previously treated for breast cancer.

Stakeholder Engagement

Description:

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.