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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

Status
Withdrawn
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05436808
Enrollment
0
Registered
2022-06-29
Start date
2022-07-15
Completion date
2029-08-31
Last updated
2023-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Breast Cancer Female, DCIS, Stage I Breast Cancer, Stage II Breast Cancer

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.

Interventions

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

Sponsors

Stony Brook University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Breast cancer recurrence5 yearsNumber of patients with recurrent breast cancer
Acute toxicity3 monthsFrequency of radiation-related adverse events
Delayed toxicity5 yearsFrequency of radiation-related adverse events
Surgical complications5 yearsNumber of patients with surgical complications

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026