Shave Margins vs. Standard Partial Mastectomy in Breast Cancer Patients

NCT02772731 | Completed DMC

• 1 other identifier: 1602017205
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 9

Brief Summary

Breast cancer is the most common malignancy affecting women in the US. Surgical management is the mainstay of therapy, and in general consists of resection of the primary tumor with either a partial mastectomy (aka "lumpectomy") or a total mastectomy. The investigators hypothesize that routine shave margins during partial mastectomy will significantly reduce positive margin rate. A positive margin means that cancerous cells were detected at the edge of the excised area. This generally mandates a return to the operating room for re-excision.

Conditions

Breast Cancer

Keywords

mastectomy

Outcome Measures

Primary Outcomes (1)

• Positive margin rate

  The effect is positive margin rate post-surgery as measured by local pathological reports. Positive margins were defined as tumor touching the edge of the specimen that was removed in patients with invasive cancer and tumor that was within 2 mm of the edge of the specimen removed in those with ductal carcinoma in situ.

  immediately after surgery

Secondary Outcomes (6)

• local recurrence rates

  up to 5 years

• patient perceived cosmesis

  1 year post-op

• patient perceived cosmesis

  5 years post-op

• volume of tissue resected

  immediately after tissue resection

• Quality of Life assessment

  1 year post-op about the last seven days

Study Arms (2)

Shave Margin

EXPERIMENTAL

After partial mastectomy, patients will be subject to intraoperative randomization to the shave margin group where additional tissue will be resected.

Procedure: Partial mastectomy plus additional Shave Margin

No Shave Margin

ACTIVE COMPARATOR

After partial mastectomy, patients will be subject to intraoperative randomization to the no shave margin group, where after initial surgery, no further tissue will be removed.

Procedure: Partial mastectomy

Interventions

Partial mastectomy plus additional Shave Margin PROCEDURE

For the shave group, additional superior, inferior, medial and lateral margins will be removed, oriented, and sent for pathologic evaluation at the local site. Resection of additional anterior and posterior margins will be left to surgeon discretion, as this will depend on if skin or fascia was taken. All surgeons participating in the study will be educated on the expectation of what is considered a "shave margin". A shave margin is defined as an additional segment of breast tissue taken from each of the superior, inferior, medial, and lateral aspects of the cavity, such that the entire circumference of the cavity is re-excised following this procedure. Orientation of each shaved margin will be done to mark the true margin.

Shave Margin

Partial mastectomy PROCEDURE

Surgeons will be instructed to close after partial mastectomy with no further excision.

No Shave Margin

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Breast cancer, stage 0-3, deemed a surgically appropriate candidate for partial mastectomy with planned procedure for the same
• Women ≥ 18 years of age
• Ability to understand and the willingness to sign a written informed consent document.
• Exlusion Criteria
• Total mastectomy
• Known metastatic disease
• Bilateral synchronous breast cancer
• Multicentric cancers requiring double lumpectomy
• Previous history of breast cancer (even in the other breast)
• Patients receiving Intraoperative radiation therapy (IORT)
• Patients who had excisional biopsy for diagnosis of their cancer (I.e., instead of a core biopsy)

Sponsors & Collaborators

• Yale University: lead

Study Sites (9)

Loma Linda University Cancer Center

Loma Linda, California, 92354, United States

Location

Watson Clinic Cancer and Research Center

Lakeland, Florida, 33805, United States

Location

William Beaumont Hospital

Troy, Michigan, 48085, United States

Location

UNC Chapel Hill

Chapel Hill, North Carolina, 27599-7213, United States

Location

Wake Forest School of Medicine

Winston-Salem, North Carolina, 27157, United States

Location

Cleveland Clinic Akron General

Akron, Ohio, 44307, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Women & Infants Hospital

Providence, Rhode Island, 02905, United States

Location

Doctors Hospital at Renaissance

Edinburg, Texas, 78539, United States

Location

Related Publications (1)

• Chagpar AB, Killelea BK, Tsangaris TN, Butler M, Stavris K, Li F, Yao X, Bossuyt V, Harigopal M, Lannin DR, Pusztai L, Horowitz NR. A Randomized, Controlled Trial of Cavity Shave Margins in Breast Cancer. N Engl J Med. 2015 Aug 6;373(6):503-10. doi: 10.1056/NEJMoa1504473. Epub 2015 May 30.

  PMID: 26028131 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Mastectomy, Segmental

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Mastectomy; Surgical Procedures, Operative

Study Officials

• Anees Chagpar, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2016
• First Posted: May 13, 2016
• Study Start: July 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: November 1, 2024
• Last Updated: January 31, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)