RECRUITING

Real-Time MRI-Guided 3-Fraction Accelerated Partial Breast Irradiation in Early Breast Cancer

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Conditions

Breast CancerDCISLCIScosmesiscosmeticbreast-conserving therapy

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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

This trial will investigate a novel 3-fraction radiation regimen for participants undergoing breast-conserving therapy (BCT) for early breast cancer that will: 1) significantly reduce the duration of treatment and can be completed in one-week (5 working days) and 2) MRI-guided radiotherapy (MRIdian) would limit the volume of normal tissue radiated and therefore resultant toxicity. The hypothesis is that 3-fraction radiation therapy can be delivered safely without compromising the therapeutic ratio. Participants can expect to be on study for follow up up to 5 years.

Official Title

A Phase II Study of Real-Time MRI-Guided 3-Fraction Accelerated Partial Breast Irradiation in Early Breast Cancer (MAPBI)

Quick Facts

Study Start:2022-05-16
Study Completion:2031-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03936478

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:40 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participants should have no contraindications to undergo MRI scan as part of radiotherapy planning and treatment.
  2. * Lumpectomy cavity must be clearly visible on CT and MRI scan at radiotherapy simulation.
  3. * Pregnancy test negative in women of child bearing potential (WOCBP).
  4. * The participant must consent to be in the study and must have signed an approved consent form conforming with institutional guidelines.
  5. * Participants with a history of non-breast malignancies are eligible if they have been disease-free for 5 or more years prior and are deemed by their physician to be at low risk for recurrence. Participants with the following cancers are eligible if diagnosed and treated within the past 5 years: carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinoma of the skin.
  6. * Suitable:
  7. * Age: \>=50 years
  8. * Margins: Negative by at least 2 mm
  9. * T Stage: Tis or T1
  10. * Cautionary:
  11. * Age: 40-49 years
  12. * Margins: Negative by at least 2 mm
  13. * T Stage: Tis or T1 OR
  14. * Age: \>=50 years IF participant has at least 1 of the pathologic factors below and does not have any "unsuitable" factors (below)
  15. * Pathologic Factors:
  16. * Size 2.1-3.0 cm (size of the invasive component)
  17. * T2
  18. * Close margins (\<2 mm)
  19. * Limited/focal Lymphovascular Space Invasion (LVSI)
  20. * ER (-)
  21. * Clinically unifocal with total size 2.1-3.0 cm (Microscopic multifocality allowed, provided the lesion is clinically unifocal (a single discrete lesion by physical examination and ultrasonography/mammography) and the total lesion size (including foci of multifocality and intervening normal breast parenchyma) falls between 2.1 and 3.0 cm).
  22. * Invasive lobular histology
  23. * Extensive Intraductal Component (EIC) \<=3 cm
  24. * Suitable Criteria, DCIS allowed if all of the following are met:
  25. * Screen-detected
  26. * Low to intermediate nuclear grade
  27. * Size \<=2.5 cm
  28. * Resected with margins negative at \>=3mm OR
  29. * Cautionary Criteria:
  30. * Pure DCIS \<=3 cm if "suitable" criteria not fully met
  31. * Men are not eligible for this study.
  32. * BRCA1/2 mutation positivity.
  33. * Age \< 40 years (American Society for Radiation Oncology (ASTRO) Unsuitable Criteria).
  34. * Positive resection margins on post operative pathology(ASTRO Unsuitable Criteria).
  35. * Palpable or radiographically suspicious ipsilateral or contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes, unless there is histologic confirmation that these nodes are negative for tumor.
  36. * Suspicious micro calcifications, densities, or palpable abnormalities (in the ipsilateral or contralateral breast) unless biopsied and found to be benign.
  37. * Non-epithelial breast malignancies such as sarcoma or lymphoma.
  38. * Proven multicentric carcinoma (invasive cancer or DCIS) (ASTRO Unsuitable Criteria).
  39. * Pure DCIS \>3 cm in size (ASTRO Unsuitable Criteria).
  40. * Presence of extensive intraductal component \>30mm (ASTRO Unsuitable Criteria).
  41. * Paget's disease of the nipple.
  42. * History of previous invasive breast cancer, DCIS, synchronous bilateral invasive or non-invasive breast cancer. (Participants with a history of LCIS treated by surgery alone are eligible.)
  43. * Surgical margins that cannot be microscopically assessed or are positive at pathologic evaluation.
  44. * Concurrent therapy with any hormonal agents such as raloxifene (Evista®), tamoxifen, Aromatase Inhibitors or other selective estrogen receptor modulators (SERMs), either for osteoporosis or breast cancer prevention or neoadjuvant therapy.
  45. * Breast implants.
  46. * Prior breast or thoracic radiotherapy for any condition or treatment plan that includes regional nodal irradiation.
  47. * Collagen vascular disease, specifically dermatomyositis with a creatinine phosphokinase level above normal or with an active skin rash, systemic lupus erythematosus, or scleroderma.
  48. * Pregnancy or lactation at the time of treatment. Women of reproductive potential must agree to use an effective non-hormonal method of contraception during therapy.
  49. * Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the participant from meeting the study requirements.
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Cancer Connect
CONTACT
800-622-8922
clinicaltrials@cancer.wisc.edu

Principal Investigator

Bethany Anderson, MD
PRINCIPAL_INVESTIGATOR
University of Wisconsin, Madison

Study Locations (Sites)

University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53705
United States

Collaborators and Investigators

Sponsor: University of Wisconsin, Madison

  • Bethany Anderson, MD, PRINCIPAL_INVESTIGATOR, University of Wisconsin, Madison

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 Date2022-05-16
Study Completion Date2031-01

Study Record Updates

Study Start Date2022-05-16
Study Completion Date2031-01

Terms related to this study

Keywords Provided by Researchers

  • cosmesis
  • cosmetic
  • breast-conserving therapy

Additional Relevant MeSH Terms

  • Breast Cancer
  • DCIS
  • LCIS