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Breast Cancer Early Stage Breast Cancer (Stage 1-3)Phase 1DESERT-INCT06671691

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

A Phase 1 study testing SBRT level I, SBRT level II and SBRT level III in people with Breast Cancer Early Stage Breast Cancer (Stage 1-3) and SBRT, run by Universitat de les Illes Balears at 1 site in Spain.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Any age, women only
What is being tested?
SBRT level I, SBRT level II and SBRT level III
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteSpain
Study dates
27 Sep 2024to Sep 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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
Show all 15Show fewer
  • 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.

Who cannot join

  • 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
Show all 22Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Spain1 site

  • Hospital Universitario Son Espases

    Palma, Balearic Islands, 07120

Other trials in Spain

About this study

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

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.

Being tested
SBRT level I, SBRT level II, SBRT level III, SBRT level IV, SBRT level V
Keywords
Breast cancer, SBRT, Radiotherapy, early stage, Definitive treatment
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SBRT level IRadiation

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

  • SBRT level IIRadiation

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

  • SBRT level IIIRadiation

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

  • SBRT level IVRadiation

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

  • SBRT level VRadiation

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

Study groups in NCT06671691
Study groupRoleWhat they receive
SBRT level I: 20GyExperimental20Gy in 1 fraction will be delivered to the tumor
Receives: Radiation: SBRT level I
SBRT level II: 23GyExperimental23Gy in 1 fraction will be delivered to the tumor
Receives: Radiation: SBRT level II
SBRT level III: 26GyExperimental26Gy in 1 fraction will be delivered to the tumor
Receives: Radiation: SBRT level III
SBRT level IV: 28GyExperimental28Gy in 1 fraction will be delivered to the tumor
Receives: Radiation: SBRT level IV
SBRT level V: 30GyExperimental30Gy in 1 fraction will be delivered to the tumor
Receives: Radiation: SBRT level V

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Establish the single-fraction radiation dose (MTD)

    To establish the single-fraction SBRT radiation dose (MTD) that causes an incidence of dose-limiting toxicities (DLTs) lower than 33%

    Measured: 3 months

Secondary outcomes (6)

  1. Chronic toxicity

    Assessed at 6 and 12 months post-treatment using CTCAE v5.0 criteria for skin, fatigue, and breast.

    Measured: 1 year

  2. Radiological response to treatment

    Measured with MRI or contrast mammography 12 months post-RT using RECIST criteria.

    Measured: 1 year

  3. Pathological response to treatment

    Between 1 and 3 core needle biopsies (CNB) will be performed, guided by ultrasound on the treated lesion at 6 and 12 months post-RT to establish the rate of residual tumor cells scored by pathology review of H\&E slides.

    Measured: 1 year

  4. Patient-reported quality of life

    Measured using the EORTC QLQ-C30 questionnaires before RT and at 3 and 12 months post-treatment.

    EORTC QLQ-C30- scale goes from 1/not at all to 4/very much. There is additionally a rate of overall health and quality of life that is a scale from 1 to 7.

    Measured: 1 year

  5. Cosmesis after treatment

    Measured using the Modified Harvard-Harris Cosmetic Scale (MHHCS) at 1, 3, 6, and 12 months post-treatment. Photographs of the breasts will be taken before treatment and at each follow-up visit, to be evaluated later using an external validation system.

    The MHCCS scale compares baseline images with those obtained post-treatment, allowing the assessment of cosmesis as follows: Poor, fair, good or excellent.

    Measured: 1 year

  6. Tumor DNA sequencing

    Tumor biopsies will be taken before and at 6 and 12 months post-treatment. Next Generation Sequencing (NGS) will be performed to characterize radiation-induced changes in tumor DNA.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 2024
  2. Study start27 Sep 2024
  3. Primary completionSep 2025 (estimated)
  4. Study completionSep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
Treatment tolerance will be the basis for allowing us to progress to the next dose level. Dose-limiting toxicity (DLT) will be defined as a G3-G4 toxicity or G2 in cases of hypo/hyperpigmentation according to the CTCAE v5.0 scale, assessing the following items: induration, ulceration, pruritus, pigmentation changes, and fatigue. If, at 3 months post-RT at the initial dose level, none of the patients present a DLT, three new patients will receive RT at the next dose level. However, if any patient in a group presents a DLT, three additional patients will be added at the same dose level. Dose escalation will continue up to 30Gy unless \>33% of patients in a single dose group experience a DLT. If \>33% of patients at a dose level experience a DLT, the study will end, and the dose level immediately below this will be selected to design the phase II of the study.
Masking
None (open label)
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06671691
Sponsor's protocol ID
IB 5560/24 PI
Acronym
DESERT-I
Status last verified
Oct 2024
First submitted
28 Oct 2024
Last updated
4 Nov 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 41521299

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SBRT level I, SBRT level II and SBRT level III in people with Breast Cancer Early Stage Breast Cancer (Stage 1-3) and SBRT, run by Universitat de les Illes Balears at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 4 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Establish the single-fraction radiation dose (MTD) (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06671691, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2024.

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