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

Breast Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02171078
• Other study ID #: 2014-0742
• Secondary ID: CE-1304-6543UW14
• Status: Completed
• Start date: June 2014
• Est. completion date: December 2017

Study information

• Verified date: December 2022
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 34359
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms

Locations

Country	Name	City	State
United States	University of Wisconsin-Madison School of Medicine and Public Health	Madison	Wisconsin

Sponsors (8)

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

Country where clinical trial is conducted

United States, 

References & Publications (5)

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 avail — View Citation

Dudley CM, Wiener AA, Stankowski-Drengler TJ, Schumacher JR, Francescatti AB, Poore SO, Greenberg CC, Neuman HB. Rates of Ipsilateral Local-regional Recurrence in High-risk Patients Undergoing Immediate Post-mastectomy Reconstruction (AFT-01). Clin Breast — View Citation

Schumacher JR, Neuman HB, Yu M, Vanness DJ, Si Y, Burnside ES, Ruddy KJ, Partridge AH, Schrag D, Edge SB, Zhang Y, Jacobs EA, Havlena J, Francescatti AB, Winchester DP, McKellar DP, Spears PA, Kozower BD, Chang GJ, Greenberg CC; Alliance ACS-CRP CCDR Brea — View Citation

Schumacher JR, Wiener AA, Greenberg CC, Hanlon B, Edge SB, Ruddy KJ, Partridge AH, Le-Rademacher JG, Yu M, Vanness DJ, Yang DY, Havlena J, Strand C, Neuman HB. Local/regional Recurrence Rates after Breast Conserving Therapy in Patients Enrolled in Legacy — View Citation

Wong ML, McMurry TL, Schumacher JR, Hu CY, Stukenborg GJ, Francescatti AB, Greenberg CC, Chang GJ, McKellar DP, Walter LC, Kozower BD. Comorbidity Assessment in the National Cancer Database for Patients With Surgically Resected Breast, Colorectal, or Lung — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Recurrence	Data elements include the date and site of recurrence, type of recurrence (e.g., local/regional or distant recurrence), and progression.	5 Years from Diagnosis
Primary	Time to Toxicity/Side Effects of Treatment	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	Within relevant timeframe of legacy clinical trial. Most trials include 2-year follow-up
Secondary	Time to Death		Within 5 years from time of diagnosis

External Links

•   University of Wisconsin Carbone Cancer Center