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

NCT05436808 | Withdrawn Early Phase 1 DMC FDA Device

• 1 other identifier: SBU-PCWRT-BREAST
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Breast Cancer Female; DCIS; Stage II Breast Cancer; Stage I Breast Cancer

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

Radiation Treatment

EXPERIMENTAL

Radiation: Partial Chest Wall Radiation Therapy

Interventions

Partial Chest Wall Radiation Therapy RADIATION

Patients will receive radiation therapy (30 Gray in 5 fractions) to the affected chest wall, delivered on consecutive days or every other day

Radiation Treatment

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• \- Received prior radiation to are to be irradiated

Sponsors & Collaborators

• Stony Brook University: lead

Study Sites (1)

Stony Brook Cancer Center

Stony Brook, New York, 11794, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Carcinoma, Intraductal, Noninfiltrating

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Breast Carcinoma In Situ; Carcinoma in Situ; Neoplasms, Ductal, Lobular, and Medullary

Study Officials

• Alexander Stessin, MD PhD

  Stony Brook University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: June 23, 2022
• First Posted: June 29, 2022
• Study Start: July 15, 2022
• Primary Completion: August 1, 2024
• Study Completion (Estimated): August 1, 2029
• Last Updated: October 18, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)