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

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Status: Suspended

Conditions: Breast Cancer

Treatments: Procedure: Aspiration of seroma fluid

Study type: Interventional

Funder types: Other

Identifiers

NCT04339517

Breast PTC

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: Female

Ages: Under 50 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)