By InvitationPhase 1

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

Spain15 participantsStarted 2024-09-27

Plain-language 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.

Who can participate

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 o…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Establish the single-fraction radiation dose (MTD)

Timeframe: 3 months

Trial details

NCT IDNCT06671691

SponsorUniversitat de les Illes Balears

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-09

View on ClinicalTrials.gov More Breast Cancer Early Stage Breast Cancer (Stage 1-3) trials

Plain-language summary

Who can participate

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.