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
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Breast Cancer Early Stage Breast Cancer (Stage 1-3)
- Sponsor
- Universitat de les Illes Balears
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Establish the single-fraction radiation dose (MTD)
- Status
- Enrolling By Invitation
- Last Updated
- last year
Overview
Brief 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.
Investigators
Jon Gadea Quinteiro
Radiation Oncologist
Universitat de les Illes Balears
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
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
Outcomes
Primary Outcomes
Establish the single-fraction radiation dose (MTD)
Time Frame: 3 months
To establish the single-fraction SBRT radiation dose (MTD) that causes an incidence of dose-limiting toxicities (DLTs) lower than 33%
Secondary Outcomes
- Chronic toxicity(1 year)
- Radiological response to treatment(1 year)
- Pathological response to treatment(1 year)
- Patient-reported quality of life(1 year)
- Cosmesis after treatment(1 year)
- Tumor DNA sequencing(1 year)