Post-Mastectomy Surveillance to Detect Recurrence in Breast Cancer Patients

Not Applicable

• Conditions: Breast Cancer
• Interventions: Device: post mastectomy ultrasound

• Registration Number: NCT02688725
• Lead Sponsor: Providence Health & Services

Brief Summary

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

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.

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2015-12-29
• Study First Submitted QC: 2016-02-17
• Study First Posted: 2016-02-23
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-27
• Last Update Posted: 2019-08-28
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ultrasound	post mastectomy ultrasound	post mastectomy ultrasound

Primary Outcome Measures

Name	Time	Method
To determine the number of breast cancer recurrences following mastectomy detected by surgeon-performed ultrasound.	3 years	To determine the number of breast cancer recurrences following mastectomy detected by surgeon-performed ultrasound during a three year trial period.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Providence Regional Cancer Partnership; 🇺🇸 Everett, Washington, United States