Study on Repeat Breast Conserving Surgery and Daily Partial Breast Radiation for Cancer Recurrence in the Same Breast

Sponsor: Case Comprehensive Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06129747

Provider View

This clinical trial is exploring whether giving radiation once a day for 15 treatments after repeat breast conserving surgery is as effective as the standard method of twice-daily radiation for 30 treatments in patients whose breast cancer has returned.

Patient Parameters

Program Overview

The study aims to find out if a new approach to radiation therapy, given once a day for 15 sessions, is as effective as the traditional method of twice-daily radiation for 30 sessions in patients who have had breast cancer return after initial breast conserving surgery. This new method could be more convenient for patients, especially those who find it difficult to attend frequent appointments.

Description

Breast cancer treatments have improved significantly, leading to better survival rates. For early-stage and some advanced breast cancers, breast conserving therapy (BCT) is common, involving a partial mastectomy followed by radiation. If cancer returns in the same breast, the usual treatment is a mastectomy. However, many patients prefer to avoid mastectomy and opt for repeat breast conserving surgery (BCS) with focused radiation. The current standard for re-irradiation is partial breast radiation given twice daily for 30 sessions, which can be challenging for patients due to the frequency of treatments. This study is testing a new method of daily radiation for 15 sessions, which may be more convenient and just as effective. Some patients with higher risk factors, like younger age or certain tumor characteristics, may receive a higher radiation dose to improve outcomes. The study will explore different ways to increase the dose safely.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of specific types of breast cancer, such as ductal carcinoma in-situ or invasive ductal carcinoma.
  • Tumor size must be less than 3 cm and treated with partial mastectomy.
  • No cancer spread to lymph nodes unless previously untreated.
  • Single tumor recurrence in the breast.
  • Clear surgical margins with no cancer cells at the edge of the removed tissue.
  • Hormonal therapy is allowed; chemotherapy can start two weeks after radiation.
  • Must be over 18 years old.
  • Must understand and agree to the study requirements.
  • Must have a performance status of 2 or less, meaning able to carry out light work.
  • Expected to live at least 12 months.
  • Open to all genders.

Exclusion Criteria

  • Cancer has spread to lymph nodes or other parts of the body.
  • Certain types of breast cancer, like invasive lobular carcinoma or extensive ductal carcinoma in-situ.
  • Multiple tumors in different areas of the breast.
  • Paget's disease of the nipple or skin involvement.
  • Certain autoimmune diseases like lupus or scleroderma.
  • Mental health or substance use issues that prevent understanding the study.
  • Pregnant or breastfeeding women due to radiation risks.
  • Known genetic mutations like BRCA 1/BRCA 2.

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