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SBRT in Early Breast Cancer in Elderly Women

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Primary completion date changed from estimate of Nov 2023 to Nov 11, 2023
    • Study completion date: Nov 2023 to Dec 31, 2026
    • Site details revised
    • Publications: details revised at 25 of 25 entries
    v3
  2. Notable Phase: Phase 1 to Not applicablev2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Surgical treatment represents the standard of local therapy in patients with early breast cancer, however in women over75, the comorbidities related to aging reduce the possibility of candidates for surgical treatment. In the United Kingdom it is estimated that over 40% of elderly women do not receive surgery for their breast cancer, and that their primary treatment is hormonal only, the so-called primary endocrinotherapy. In Italy the recent AIOM guidelines of 2019 exclude, in patients with hormone-sensitive disease and age older than 70, the omission of surgery in favor of hormone therapy alone, thus underlining the importance of a treatment local. However, there are currently no local treatments that could in any way effectively control the primary tumor. In recent years, SRT has widely found space as a therapeutic alternative in patients not fit for surgery. Stereotactic Radiotherapy is a non-invasive treatment with ablative intent obtained with highly focused high intensity fields for a few fractions (generally 1-5). It is the standard treatment for surgically inoperable lung cancers, and is also used in the treatment of liver metastases, intermediate-risk prostate cancer and locally advanced pancreatic cancers. The applications of stereotactic treatment in breast cancer are limited to the neoadjuvant and adjuvant setting. Against this backgroung, in elderly patients with localized breast cancer candidates for hormonal therapy and non-fit for surgery due to age or comorbidity, a SBRT could more effectively control local disease, not excluding local treatment rather than in itself it is considered very important.
Trial Details
NCT Number NCT05071105
Lead Sponsor University of Rome Tor Vergata
Conditions
(from sponsor)
Breast Neoplasm Female
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov