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Enrolling by invitationPhase 1

Tests single-dose radiotherapy as treatment for early low-risk breast cancer

Tests different radiation doses on the tumor in women with early breast cancer.

Plain-language title generated from the registry record
Registry title: A Phase I Dose-escalation Trial of Definitive Single Dose Stereotactic Body Radiotherapy in Low-risk Breast Cancer Patients: DESERT I Trial

Key facts

Where
Palma, SpainSee the site
Phase
Phase 1

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adult women with a small, low-risk breast cancer who cannot have surgery or refuse it. It tests single-dose stereotactic radiotherapy at five dose levels.

Age
Over 18 years
Sex
Women only
Disease stage
Invasive non-lobular breast cancer, tumor under 3 cm (1.2 in) on MRI or contrast mammography, at least 0.5 cm (0.2 in) from the skin or rib cage, no lymph node involvement (N0), no lymphovascular invasion, no spread to other organs.
Earlier treatment
Must have a documented reason why surgery is not possible, or must refuse surgery. No earlier chest radiotherapy and no earlier breast cancer in the same breast.
Biomarker or test result
Estrogen and/or progesterone receptor positive and HER2 negative. A positive BRCA mutation excludes people.

Main reasons for not taking part

  • Invasive lobular carcinoma or ductal carcinoma in situ
  • Positive BRCA mutation or multicentric tumor
  • Pregnant or breastfeeding
  • Breast implants or pacemaker
  • Active scleroderma, lupus or other connective tissue disease

Read by machine on 12 November 2026.

Where in Spain

  • Hospital Universitario Son EspasesPalma, SpainNo longer taking part

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Trial details

Who runs it
Universitat de les Illes Balears
Trial code
NCT06671691
Record updated
4 November 2024
Original description
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.Read full original descriptionShow less

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

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.

Inclusion: 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: History of previous breast cancer in the same breast; Previous thoracic radiotherapy; Patient with breast implants; Patients with metastatic disease; Scleroderma, lupus, or other connective tissue diseases with active flares; 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; Pregnant or actively breastfeeding; Unable to undergo MRI or contrast mammography; Unable to tolerate the supine position; Patients with pacemakers; Inability to understand and sign the informed consent.

ClinicalTrials.gov NCT06671691