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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:

• Participants' recurrences must have histologically confirmed ductal carcinoma in-situ, invasive ductal, medullary, papillary, colloid (mucinous), tubular or mixed histologies.

• Lesion size \< 3 cm treated with a partial mastectomy. Participants with invasive cancer and clinically and radiographically negative axillas do not require an axillary lymph node sampling unless they did not have prior axillary lymph node sampling (e.g. previous cancer was DCIS). Patients with DCIS as their recurrence do not require surgical assessment of the axilla. Repeat sentinel lymph node biopsy is permitted.

• Negative resection margins with at least a no tumor on ink or a negative re-excision.

• Hormonal therapy is allowed. If chemotherapy is planned, it can be delivered either prior or after the radiation is delivered. There must be at least 2 weeks between radiation and chemotherapy. HER2 directed therapy can be delivered concurrently with radiation.

• Participants must be \> 18 years of age. Because no dosing or adverse event data are currently available on the use of breast re-irradiation in participants ≤18 years of age, children are excluded from this study.

• Participants must have the ability to understand and the willingness to sign a written informed consent document.

• Performance status: ECOG Performance status ≤ 2.

• Life expectancy of ≥ 12months, in the opinion of and as documented by the investigator.

• Not based on gender; this trial is open to any gender, defined as self-representation of gender identity.

Locations
United States
Ohio
Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center
RECRUITING
Cleveland
University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
RECRUITING
Cleveland
Contact Information
Primary
Janice Lyons, MD
Janice.lyons@uhhospitals.org
(216) 844-2514
Time Frame
Start Date: 2023-11-30
Estimated Completion Date: 2029-08-09
Participants
Target number of participants: 55
Treatments
Experimental: Radiation Therapy(RT)
There will be one treatment cohort. Radiation therapy will be delivered daily for 15 daily fractions, 2.67Gy per fraction, delivered using a 3-D or IMRT(Intensity Modulate Radiation Therapy) plan. For participants with high-risk features deemed by the radiation oncologist who would otherwise be a candidate for a boost (age \<50, high grade, poor biology, close margins), 48 Gy delivered in fifteen fractions of 3.2 Gy is allowed.
Related Therapeutic Areas
Sponsors
Leads: Case Comprehensive Cancer Center

This content was sourced from clinicaltrials.gov