Post-Treatment Surveillance in Breast Cancer: Bringing CER to the Alliance
| Status: | Completed |
|---|---|
| Conditions: | Breast Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/21/2018 |
| Start Date: | June 2014 |
| End Date: | December 2017 |
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.
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.
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.
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.
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:
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