RECRUITING

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

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Conditions

Breast CancerTumor, BreastRadiation TherapyIn-Breast RecurrenceTumorRe-irradiation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-11-30
Study Completion:2029-08-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06129747

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.

Ages Eligible for Study:19 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participants' recurrences must have histologically confirmed ductal carcinoma in-situ, invasive ductal, medullary, papillary, colloid (mucinous), or tubular histologies.
  2. * 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.
  3. * Unifocal breast cancer recurrence.
  4. * 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.
  5. * 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.
  6. * 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.
  7. * Participants must have the ability to understand and the willingness to sign a written informed consent document.
  8. * Performance status: ECOG Performance status ≤ 2.
  9. * Life expectancy of ≥ 12months, in the opinion of and as documented by the investigator.
  10. * Not based on gender; this trial is open to any gender, defined as self-representation of gender identity.
  1. * Participants with nodal or distant metastatic disease
  2. * 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.
  3. * 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.
  4. * 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.
  5. * Participants with Paget's disease of the nipple.
  6. * Participants with skin involvement.
  7. * Participants with systemic lupus erythematosus requiring pharmacologic management, scleroderma, or dermatomyositis.
  8. * Participants with psychiatric, neurologic, or addictive disorders that would preclude obtaining informed consent.
  9. * Participants who are pregnant or lactating due to potential fetal exposure to radiation and unknown effects of radiation on lactating females.
  10. * Participants with known BRCA 1/BRCA 2 mutations.

Contacts and Locations

Study Contact

Janice Lyons, MD
CONTACT
(216) 844-2514
Janice.lyons@uhhospitals.org

Principal Investigator

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

Study Locations (Sites)

University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5065
United States
Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44195
United States

Collaborators and Investigators

Sponsor: Case Comprehensive Cancer Center

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-30
Study Completion Date2029-08-09

Study Record Updates

Study Start Date2023-11-30
Study Completion Date2029-08-09

Terms related to this study

Keywords Provided by Researchers

  • Radiation Therapy
  • In-Breast Recurrence
  • Tumor
  • Re-irradiation

Additional Relevant MeSH Terms

  • Breast Cancer
  • Tumor, Breast