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

NCT02171078 | Completed

• 5 other identifiers: 2014-0742CE-1304-6543UW14041A539713SMPH/SURGERY/SURG ONC
• Study Type: observational
• Target: 34,359
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Neoplasms

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Time to Death

  Within 5 years from time of diagnosis

Study Arms (3)

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.

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.

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.

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Research Aim 1: Patients who have participated in 1 of 15 closed clinical trials; Research Aim 2: National Cancer Database (NCDB); Research Aim 3: Purposive sample of breast cancer survivor, breast cancer treatment provider, and cancer health services researcher stakeholders

You may qualify if:

• 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)

You may not qualify if:

• None

Sponsors & Collaborators

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

Study Sites (1)

University of Wisconsin-Madison School of Medicine and Public Health

Madison, Wisconsin, 53792, United States

Location

Related Publications (11)

• 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 Breast Cancer Surveillance Working Group. Surveillance Imaging vs Symptomatic Recurrence Detection and Survival in Stage II-III Breast Cancer (AFT-01). J Natl Cancer Inst. 2022 Oct 6;114(10):1371-1379. doi: 10.1093/jnci/djac131.

  PMID: 35913454 RESULT

• 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 Trials of the Alliance for Clinical Trials in Oncology (AFT-01). Ann Surg. 2023 May 1;277(5):841-845. doi: 10.1097/SLA.0000000000005776. Epub 2022 Dec 14.

  PMID: 36521077 RESULT

• 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 Cancer. 2021 Oct;21(5):433-439. doi: 10.1016/j.clbc.2021.03.009. Epub 2021 Mar 27.

  PMID: 34103255 RESULT

• 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.

  PMID: 30565039 RESULT

• 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 Cancer (AFT-01, -02, -03). J Oncol Pract. 2018 Oct;14(10):e631-e643. doi: 10.1200/JOP.18.00175. Epub 2018 Sep 12.

  PMID: 30207852 RESULT

• Krecko LK, Neuman HB, Greenberg CC, Wilke LG, Hanlon BM, Edge SB, Ruddy KJ, Partridge AH, Le-Rademacher J, Yang DY, Havlena J, R Schumacher J. Validation of the AJCC 8th Edition Breast Cancer Prognostic Staging System in Legacy Alliance Trials (AFT-01). Ann Surg Oncol. 2024 Sep;31(9):5880-5887. doi: 10.1245/s10434-024-15477-5. Epub 2024 Jun 2.

  PMID: 38825628 DERIVED

• Neuman HB, Schumacher JR, Edge SB, Ruddy KJ, Partridge AH, Yu M, Vanness DJ, Hanlon BM, Le-Rademacher JG, Yang DY, Havlena J, Strand CA, Greenberg CC. The influence of anatomic stage and receptor status on first recurrence for breast cancer within 5 years (AFT-01). Cancer. 2023 May 1;129(9):1351-1360. doi: 10.1002/cncr.34656. Epub 2023 Mar 6.

  PMID: 36872873 DERIVED

• Stankowski-Drengler TJ, Schumacher JR, Hanlon B, Livingston-Rosanoff D, Van de Walle K, Greenberg CC, Wilke LG, Neuman HB. Outcomes for Patients with Residual Stage II/III Breast Cancer Following Neoadjuvant Chemotherapy (AFT-01). Ann Surg Oncol. 2020 Mar;27(3):637-644. doi: 10.1245/s10434-019-07846-2. Epub 2020 Jan 3.

  PMID: 31900808 DERIVED

• Schumacher JR, Neuman HB, Chang GJ, Kozower BD, Edge SB, Yu M, Vanness DJ, Si Y, Jacobs EA, Francescatti AB, Spears PA, Havlena J, Adesoye T, McKellar D, Winchester D, Burnside ES, Greenberg CC; Alliance ACS-CRP CCDR Breast Cancer Surveillance Working Group. A National Study of the Use of Asymptomatic Systemic Imaging for Surveillance Following Breast Cancer Treatment (AFT-01). Ann Surg Oncol. 2018 Sep;25(9):2587-2595. doi: 10.1245/s10434-018-6496-4. Epub 2018 May 17.

  PMID: 29777402 DERIVED

• Adesoye T, Schumacher JR, Neuman HB, Edge S, McKellar D, Winchester DP, Francescatti AB, Greenberg CC; Alliance ACS-CRP CCDR Breast Cancer Surveillance Working Group. Use of Breast Imaging After Treatment for Locoregional Breast Cancer (AFT-01). Ann Surg Oncol. 2018 Jun;25(6):1502-1511. doi: 10.1245/s10434-018-6359-z. Epub 2018 Feb 15.

  PMID: 29450753 DERIVED

• Neuman HB, Schumacher JR, Francescatti AB, Adesoye T, Edge SB, Vanness DJ, Yu M, McKellar D, Winchester DP, Greenberg CC; Alliance/American College of Surgeons Clinical Research Program Cancer Care Delivery Research Breast Cancer Surveillance Working Group. Risk of Synchronous Distant Recurrence at Time of Locoregional Recurrence in Patients With Stage II and III Breast Cancer (AFT-01). J Clin Oncol. 2018 Apr 1;36(10):975-980. doi: 10.1200/JCO.2017.75.5389. Epub 2018 Jan 31.

  PMID: 29384721 DERIVED

Related Links

• University of Wisconsin Carbone Cancer Center

MeSH Terms

Conditions

Breast Neoplasms; Recurrence

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Caprice C Greenberg, MD MPH

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2014
• First Posted: June 23, 2014
• Study Start: June 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: December 27, 2022

Record last verified: 2022-12

Locations

US (1)