Post-Mastectomy Surveillance to Detect Recurrence in Breast Cancer Patients

Study Overview
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Brief Summary
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Currently, there is no standard recommendation for using imaging studies to check patients for breast cancer recurrence who have been treated with mastectomy. The investigator proposes performing in-office ultrasound examinations of these patients to determine if this would be helpful in identifying an expected 5-7% of patients with breast cancer recurrences following mastectomy.

Detailed Description
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The investigator hypothesizes that surgeon-directed ultrasound is a feasible, accurate, and cost-effective strategy for local recurrence surveillance in breast cancer patients after mastectomy. Toward examining these hypotheses, the investigators propose the following Specific Aims: Aim I: To determine the number of breast cancer recurrences following mastectomy detected by surgeon-performed ultrasound. Aim II: To determine the sensitivity and specificity of surgeon-performed ultrasound for the detection of post-mastectomy breast cancer recurrence. Aim III: To estimate the cost of performing surgeon-directed ultrasound for the detection of post-mastectomy breast cancer recurrence from the perspective of a third party payer relative to standard surveillance alone.

Official Title
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Post-Mastectomy Surveillance to Detect Locally Recurrent Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Device: post mastectomy ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: must be ≥ 18 years of age. histologic diagnosis of invasive (ductal or lobular) or in situ (ductal) breast cancer (American Joint Committee on Cancer, 7th edition stage 0, I, II, III, or IV) -previously treated with mastectomy Exclusion Criteria: pregnant or breast feeding. cannot tolerate lying supine for breast ultrasound examination. mastectomy for lobular carcinoma in situ, atypical ductal hyperplasia, or extensive microcalcifications in the absence of concurrent DCIS or invasive breast cancer

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ultrasound<br>post mastectomy ultrasound | Device: post mastectomy ultrasound<br>* post mastectomy ultrasound<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the number of breast cancer recurrences following mastectomy detected by surgeon-performed ultrasound. | To determine the number of breast cancer recurrences following mastectomy detected by surgeon-performed ultrasound during a three year trial period. | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The sensitivity of surgeon performed breast ultrasound to detect breast cancer recurrence after mastectomy will be measured. | Sensitivity measures the proportion of patients that have pathologically confirmed breast cancer recurrences that were correctly identified as such by surgeon performed ultrasound. | 3 years |