RecruitingNot ApplicableNCT05071105

SBRT in Early Breast Cancer in Elderly Women

Stereotactic Ablative Body Radiotherapy in Elderly Women With Early Breast Cancer Unsuitable for Surgery and Elected to Receive Primary Endocrine Therapy Alone


Sponsor

University of Rome Tor Vergata

Enrollment

30 participants

Start Date

Jan 1, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 75 Years

Inclusion Criteria4

  • Age ≥ 75 years
  • Histologically confirmed diagnosis of local disease only (cT1-T2 N0 M0)
  • Luminal like A or B (estrogen receptor positive and/or progesterone receptor positive and Her2 negative Tumors)
  • SBRT within 2 months after hormonal therapy start

Exclusion Criteria5

  • Metastatic Disease
  • Evidence of loco-regional nodal disease
  • Multifocal or multicentric tumors
  • Prior radiotherapy to the region of the study cancer that would result in overlap of therapy fields
  • Concurrent systemic disorders that contraindicate radiotherapy

Interventions

RADIATIONStereotactic Body Radiation Therapy

In every group, the dose is prescribed at the edge of the PTV. To be approved, 95% of the PTV will be conformally covered by the prescription isodose surface and 99% of PTV will receive a minimum of 90% of the prescription dose.


Locations(1)

Fondazione Policlinico Tor Vergata

Rome, Rome, Italy

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NCT05071105


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