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

Description

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

Breast Cancer, Tumor, Breast

Study Overview

Study Details

Study overview

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.

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

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

Condition
Breast Cancer
Intervention / Treatment

-

Contacts and Locations

Cleveland

University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center, Cleveland, Ohio, United States, 44106-5065

Cleveland

Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center, Cleveland, Ohio, United States, 44195

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Participants' recurrences must have histologically confirmed ductal carcinoma in-situ, invasive ductal, medullary, papillary, colloid (mucinous), or tubular histologies.
  • * Lesion size \< 3 cm treated with a partial mastectomy. Participants with 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). Repeat sentinel lymph node biopsy is permitted.
  • * Unifocal breast cancer recurrence.
  • * Negative resection margins with at least a no tumor on ink from invasive and 2 mm margins for ductal carcinoma in-situ or a negative re-excision.
  • * Hormonal therapy is allowed. If chemotherapy is planned, the radiation is delivered first and chemotherapy must begin no earlier than two weeks following completion of 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.
  • * Participants with nodal or distant metastatic disease
  • * Participants with invasive lobular carcinoma, extensive lobular carcinoma in-situ, extensive ductal carcinoma in-situ (spanning more than 3 cm), or uncontrolled nonepithelial breast malignancies such as lymphoma or sarcoma.
  • * Participants with multicentric carcinoma (tumors in different quadrants of the breast or tumors separated by at least 4 cm). Palpable or radiographically suspicious contralateral axillary, ipsilateral or contralateral supraclavicular, infraclavicular, or internal mammary lymph nodes unless these are histologically or cytologically confirmed negative.
  • * Extensive intraductal component (EIC) by the Harvard definition, i.e. 1) more than 25% of the invasive tumor is DCIS and DCIS present in adjacent breast tissue. Presence of an EIC increases the chance of local recurrence, and as such, one might not be a candidate for repeat breast conservation.
  • * Participants with Paget's disease of the nipple.
  • * Participants with skin involvement.
  • * Participants with systemic lupus erythematosus requiring pharmacologic management, scleroderma, or dermatomyositis.
  • * Participants with psychiatric, neurologic, or addictive disorders that would preclude obtaining informed consent.
  • * Participants who are pregnant or lactating due to potential fetal exposure to radiation and unknown effects of radiation on lactating females.
  • * Participants with known BRCA 1/BRCA 2 mutations.

Ages Eligible for Study

19 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Case Comprehensive Cancer Center,

Janice Lyons, MD, PRINCIPAL_INVESTIGATOR, University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Study Record Dates

2029-08-09