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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

34359 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-06-30

Study Completion Date

2017-12-31

Brief Summary

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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

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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.

Conditions

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Breast Neoplasms

Keywords

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

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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Alliance for Clinical Trials Database

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.

No interventions assigned to this group

National Cancer Database

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.

No interventions assigned to this group

Stakeholder Engagement

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.

No interventions assigned to this group

Eligibility Criteria

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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

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Caprice C Greenberg, MD MPH

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

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University of Wisconsin-Madison School of Medicine and Public Health

Madison, Wisconsin, United States

Site Status

Countries

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United States

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

Alliance for Clinical Trials Database

National Cancer Database

Stakeholder Engagement

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Patient-Centered Outcomes Research Institute

American College of Surgeons

Alliance for Clinical Trials in Oncology

Harvard University

Dana-Farber Cancer Institute

M.D. Anderson Cancer Center

University of North Carolina, Chapel Hill

University of Wisconsin, Madison

Responsible Party

Principal Investigators

Caprice C Greenberg, MD MPH

Locations

University of Wisconsin-Madison School of Medicine and Public Health

Countries

References

Adesoye T, Schumacher J, Greenberg CC. ASO Author Reflections: Use of Breast Imaging After Treatment for Locoregional Breast Cancer (AFT-01). Ann Surg Oncol. 2019 Dec;26(Suppl 3):553-554. doi: 10.1245/s10434-018-7070-9. Epub 2018 Dec 18. No abstract available.

Related Links

Other Identifiers

CE-1304-6543

UW14041

A539713

SMPH/SURGERY/SURG ONC

2014-0742