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

Early Phase 1

Withdrawn

• Conditions: Breast Cancer Female; Breast Cancer; DCIS; Stage II Breast Cancer; Stage I Breast Cancer
• Interventions: Radiation: Partial Chest Wall Radiation Therapy

• Registration Number: NCT05436808
• Lead Sponsor: Stony Brook University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-23
• Study First Submitted QC: 2022-06-23
• Study First Posted: 2022-06-29
• Study Start: 2022-07-15
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-16
• Last Update Posted: 2023-10-18
• Primary Completion: 2024-08
• Study Completion: 2029-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Radiation Treatment	Partial Chest Wall Radiation Therapy	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

Stony Brook Cancer Center; 🇺🇸 Stony Brook, New York, United States