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Enrolling by invitation NCT06671691

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

Phase I Interventional Breast Cancer Early Stage Breast Cancer (Stage 1-3) SBRT

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SBRT level I, SBRT level II, SBRT level III, SBRT level IV.
Who it may be relevant to
Registry conditions: Breast Cancer Early Stage Breast Cancer (Stage 1-3), SBRT. Basic parameters: No limits · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Phase I Dose-Escalation Clinical Trial of Definitive Single Dose Stereotactic Body Radiotherapy in Patients with Low-risk Hormone Receptor-positive and Her2-negative Breast Cancer Not Suitable or Who Refuse Surgery: DESERT I Trial

Overview

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.

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

Primary outcome measures

  • Establish the single-fraction radiation dose (MTD) [Time frame: 3 months]
Secondary outcome measures (6)
  • Chronic toxicity [Time frame: 1 year]
  • Radiological response to treatment [Time frame: 1 year]
  • Pathological response to treatment [Time frame: 1 year]
  • Patient-reported quality of life [Time frame: 1 year]
  • Cosmesis after treatment [Time frame: 1 year]
  • Tumor DNA sequencing [Time frame: 1 year]

Eligibility criteria

Inclusion criteria

  • Over 18 years of age
  • Female gender
  • ECOG score 0-2
  • Positive biopsy for invasive non-lobular breast tumor histology
  • Tumor < 3 cm in diameter as measured by MRI or contrast mammography
  • Tumor located ≥ 0.5 cm from the skin or rib cage, clinically or radiologically
  • Positive estrogen and/or progesterone receptors
  • HER2 negative
  • No lymphovascular invasion in the biopsy
  • Tumor must be clinically and radiologically N0 (no lymph node involvement). If a suspicious lymph node is seen, it must be biopsied and show a negative result
  • Patient weight below 220 kg (weight limit for the treatment table)
  • Ability to tolerate the supine position for 20 minutes during treatment
  • Able to undergo MRI and/or contrast mammography
  • Not pregnant; women of childbearing potential will undergo a pregnancy test to rule this out
  • Contraindication to or refusal of surgical treatment, which must be explicitly documented in the medical record.

Exclusion criteria

  • Under 18 years of age
  • Male gender
  • ECOG score 3-4
  • Positive biopsy for invasive lobular carcinoma or ductal carcinoma in situ
  • Tumor ≥ 3 cm in diameter as measured by MRI
  • Tumor located < 0.5 cm from the skin or rib cage, clinically or radiologically
  • Negative estrogen and progesterone receptors
  • HER2 positive
  • Presence of lymphovascular invasion in the biopsy
  • Positive BRCA mutation
  • Multicentric tumor
  • Tumor with positive axillary lymph nodes
  • Patients with metastatic disease
  • History of previous breast cancer in the same breast
  • Previous thoracic radiotherapy
  • Pregnant or actively breastfeeding
  • Unable to undergo MRI or contrast mammography
  • Unable to tolerate the supine position
  • Patient with breast implants
  • Patients with pacemakers
  • Scleroderma, lupus, or other connective tissue diseases with active flares
  • Inability to understand and sign the informed consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

Spain · 1 center
  • Hospital Universitario Son Espases — Palma

Publications

  • Gadea-Quinteiro J, Mestre F, Alomar M, Gonzalez-Alcantud I, Torres-Garcia S, Garcia-Zanoguera C, Perello A, Camarasa P, Matheu G, Sanso M, Cordoba O. Definitive single-fraction ablative radiotherapy for early-stage breast cancer: DESERT-I trial - a dose-escalation study protocol. Radiat Oncol. 2026 Jan 12;21(1):9. doi: 10.1186/s13014-025-02735-3. PMID 41521299

Identifiers

NCT: NCT06671691 · IB 5560/24 PI

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗