Actively Recruiting

Phase 2
Age: 19Years +
All Genders
NCT06129747

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

Led by Case Comprehensive Cancer Center · Updated on 2026-05-07

55

Participants Needed

2

Research Sites

297 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 19Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Recurrence must be confirmed as ductal carcinoma in-situ, invasive ductal, medullary, papillary, colloid (mucinous), tubular, or mixed histologies
  • At least 3 years must have passed since last whole breast radiation
  • Lesion size less than 3 cm treated with partial mastectomy
  • Negative resection margins with no tumor on ink or negative re-excision
  • Invasive cancer participants must have negative restaging by CT chest/abdomen and bone scan or PET
  • Hormonal therapy allowed; chemotherapy allowed before or after radiation with 2-week gap; HER2 therapy can be given with radiation
  • Participants must be 18 years or older
  • Ability and willingness to sign informed consent
  • ECOG performance status 2 or less
  • Life expectancy of at least 12 months
  • Open to all genders based on self-representation of gender identity
Not Eligible

You will not qualify if you...

  • Nodal or distant metastatic disease less than 3 years since prior radiation
  • Invasive pure lobular carcinoma, extensive lobular carcinoma in-situ, extensive ductal carcinoma in-situ greater than 3 cm, or uncontrolled nonepithelial breast cancers
  • Multicentric carcinoma or suspicious lymph nodes unless confirmed negative
  • Paget's disease of the nipple
  • Skin involvement
  • Scleroderma or dermatomyositis
  • Psychiatric, neurologic, or addictive disorders preventing informed consent
  • Pregnant or lactating females
  • Known BRCA 1 or BRCA 2 mutations

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 2 locations

1

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

Cleveland, Ohio, United States, 44106-5065

Actively Recruiting

2

Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, United States, 44195

Actively Recruiting

Loading map...

Research Team

J

Janice Lyons, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here