RecruitingPhase 2NCT06129747

Repeat Breast Conserving Surgery Followed by Daily Partial Breast Irradiation in Ipsilateral Breast

Repeat Breast Conserving Surgery Followed by Daily Partial Breast Irradiation for Participants With Ipsilateral Breast Tumor Recurrence Treated Initially With Breast Conserving Surgery and Whole Breast Radiation Therapy


Sponsor

Case Comprehensive Cancer Center

Enrollment

55 participants

Start Date

Nov 30, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The standard treatment for participants whose cancer has returned after breast conserving surgery is radiation given twice daily (separated by at least 6 hours) for a total of 30 treatments. The purpose of this study is to find out if giving radiation once a day for 15 treatments after repeat breast conserving surgery works as well as giving it the standard way.


Eligibility

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying whether patients whose breast cancer has come back in the same breast after prior treatment can be successfully treated again with breast-conserving surgery (lumpectomy) followed by targeted partial breast radiation, rather than requiring full mastectomy. **You may be eligible if:** - You are over 18 with a confirmed recurrence of breast cancer in the same breast (DCIS or invasive cancer) - The recurrent tumor is smaller than 3 cm - It has been at least 3 years since you completed your prior course of whole breast radiation - Your surgical margins are negative (no cancer cells at the edges) - You have no evidence of distant spread (metastatic disease) - Your performance status is adequate (ECOG score 2 or less) and life expectancy is at least 12 months **You may NOT be eligible if:** - Your cancer has spread to lymph nodes or distant organs within 3 years of prior radiation - You have pure lobular carcinoma or multicentric cancer (tumors in different parts of the breast) - You have active skin involvement, Paget's disease, or scleroderma/dermatomyositis - You are pregnant or breastfeeding - You have a known BRCA1 or BRCA2 mutation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONRadiation Therapy

Weeks 1, 2 and 3 * Weeks 1, 2 and 3 will include 5 days of treatment. * One radiation treatment to breast on each of the 5 days. Each radiation treatment session will last a 30 minutes.


Locations(2)

University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

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NCT06129747


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