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A Phase I Dose-escalation Trial of Definitive Single Dose Stereotactic Body Radiotherapy in Low-risk Breast Cancer Patients: DESERT I Trial

NCT06671691 · Status: ENROLLING_BY_INVITATION · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2024-11-04

No results posted yet for this study

Summary

Radiotherapy (RT) is a fundamental pillar in the fight against cancer. In the case of breast cancer, RT has traditionally been applied as an adjuvant treatment following surgery. However, in recent years, there has been research into the potential benefit of administering RT prior to surgery in a neoadjuvant manner. Given that these studies have shown promising results, it is logical to think that certain patients could benefit from exclusive RT treatment, thereby avoiding surgery and its possible sequelae. This study is a phase I dose-escalation clinical trial with sequential assignment, open-label, in which five different doses (20Gy, 23Gy, 26Gy, 28Gy, and 30Gy) will be tested on the tumor using stereotactic body radiotherapy (SBRT) technique.

The aim of the study is to determine the maximum tolerated dose (MTD) based on acute toxicity, which will allow us to proceed with a phase II clinical trial to confirm efficacy and assess the late toxicity of the treatment. Secondary objectives include assessing the pathological response via core needle biopsy (CNB), radiological response, quality of life, and cosmesis. Additionally, molecular studies will be conducted on tissue and through liquid biopsy; pre- and post-treatment, we aim to identify mutations and predictors of response.

Conditions

  • Breast Cancer Early Stage Breast Cancer (Stage 1-3)
  • SBRT

Interventions

RADIATION

SBRT level I

20Gy in 1 fraction will be tested on the tumor using stereotactic body radiotherapy (SBRT) technique

RADIATION

SBRT level II

23Gy in 1 fraction will be tested on the tumor using stereotactic body radiotherapy (SBRT) technique

RADIATION

SBRT level III

26Gy in 1 fraction will be tested on the tumor using stereotactic body radiotherapy (SBRT) technique

RADIATION

SBRT level IV

28Gy in 1 fraction will be tested on the tumor using stereotactic body radiotherapy (SBRT) technique

RADIATION

SBRT level V

30Gy in 1 fraction will be tested on the tumor using stereotactic body radiotherapy (SBRT) technique

Sponsors & Collaborators

  • Universitat de les Illes Balears

    lead OTHER

Principal Investigators

  • Jon Gadea Quinteiro, Principal investigator · Universitat de les Illes Balears

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-27
Primary Completion
2025-09-30
Completion
2027-09-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06671691 on ClinicalTrials.gov