Postoperative Identification of Tumor Cells At the Lumpectomy Site of Patients with Early Breast Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-17

Study Completion Date

2026-08-30

Brief Summary

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For early breast cancer, local surgery followed by breast radiation is a standard local treatment. It has been found that the original primary tumor site, the lumpectomy site, is the commonest location of local relapse. The researchers think that such relapse occurs because of persistent tumor cells (PTCs) at the lumpectomy site even when conventional pathology reports indicate complete resection with clear margins. The researchers propose to analyze the lumpectomy fluid (seroma) of patients who are one to six weeks post-surgery for the presence or absence of tumor cells using new technology. Results of this study may help identify women who may have increased local relapse risk beyond that suggested by conventional pathology and clinical features; it may also help identify women at very low risk of local relapse who could avoid any additional treatment after local surgery.

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Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Interventions

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Aspiration of seroma fluid

Fluid will be collected from the lumpectomy site of patients between one to six weeks post-surgery and tested for the presence of persistent tumor cells (PTCs).

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Women with pathologic stage I to IIB invasive mammary breast cancer.
2. Tumor size over 1 cm.
3. Patient age 50 years or younger.
4. Primary tumor non-lobular.
5. Primary tumor non-low grade or Oncotype DX score \> 18.
6. Patient is six weeks or earlier post-lumpectomy.
7. Seroma is clinically palpable and symptomatic causing discomfort and/or swelling of the lumpectomy site OR re-excision of the lumpectomy site is planned.

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No