Partial Chest Wall Radiation Therapy After Surgery for Lymph Node Negative Breast Cancer

Prospective Pilot Study of Partial Chest Wall Radiation Therapy (PCWRT) for Positive or Close Margins After Modified Radical Mastectomy for Lymph Node-Negative Breast Cancer

The standard treatment for breast cancer when cancer cells were found near or within the margins of the tissue that is removed during breast surgery, is radiation of the entire chest wall. This may be considered overtreatment since the only reason for doing so is that cancer cells were near or in the margins of the breast tissue that was removed. In this study, the amount of radiation treatment will be limited to the area where the remaining cancer cells were found after surgery.

The purpose of this study is to find out if partial chest wall radiation therapy is as good as whole chest wall radiation therapy in reducing the risk of breast cancer cancer coming back.

Study Overview

• Status: Withdrawn
• Conditions: Breast Cancer; Stage I Breast Cancer; Stage II Breast Cancer; Breast Cancer Female; DCIS
• Intervention / Treatment: Radiation: Partial Chest Wall Radiation Therapy

• Study Type: Interventional
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • New York
    • Stony Brook, New York, United States, 11794
      • Stony Brook Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• DCIS or stage T1 or T2 invasive breast cancer, lymph node negative
• Must have undergone mastectomy
• Presence of cancer cells on or close to surgical margins
• Negative pregnancy test for women
• Must receive radiation at Stony Brook University Hospital

Exclusion Criteria

- Received prior radiation to are to be irradiated

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Radiation Treatment	Radiation: Partial Chest Wall Radiation Therapy; Patients will receive radiation therapy (30 Gray in 5 fractions) to the affected chest wall, delivered on consecutive days or every other day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Breast cancer recurrence	Number of patients with recurrent breast cancer	5 years
Acute toxicity	Frequency of radiation-related adverse events	3 months
Delayed toxicity	Frequency of radiation-related adverse events	5 years
Surgical complications	Number of patients with surgical complications	5 years

Collaborators and Investigators

• Sponsor: Stony Brook University
• Investigators: Principal Investigator: Alexander Stessin, MD PhD, Stony Brook University

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2022
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2029

Study Registration Dates

• First Submitted: June 23, 2022
• First Submitted That Met QC Criteria: June 23, 2022
• First Posted (Actual): June 29, 2022

Study Record Updates

• Last Update Posted (Actual): October 18, 2023
• Last Update Submitted That Met QC Criteria: October 16, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: SBU-PCWRT-BREAST

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No