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

NCT06671691 | Enrolling By Invitation Phase 1 DMC

• 1 other identifier: IB 5560/24 PI
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer Early Stage Breast Cancer (Stage 1-3); SBRT

Keywords

Breast cancer; SBRT; Radiotherapy; early stage; Definitive treatment

Outcome Measures

Primary Outcomes (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%

  3 months

Secondary Outcomes (6)

• 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

Study Arms (5)

SBRT level I: 20Gy

EXPERIMENTAL

20Gy in 1 fraction will be delivered to the tumor

Radiation: SBRT level I

SBRT level II: 23Gy

EXPERIMENTAL

23Gy in 1 fraction will be delivered to the tumor

Radiation: SBRT level II

SBRT level III: 26Gy

EXPERIMENTAL

26Gy in 1 fraction will be delivered to the tumor

Radiation: SBRT level III

SBRT level IV: 28Gy

EXPERIMENTAL

28Gy in 1 fraction will be delivered to the tumor

Radiation: SBRT level IV

SBRT level V: 30Gy

EXPERIMENTAL

30Gy in 1 fraction will be delivered to the tumor

Radiation: SBRT level V

Interventions

SBRT level I RADIATION

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

SBRT level I: 20Gy

SBRT level II RADIATION

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

SBRT level II: 23Gy

SBRT level III RADIATION

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

SBRT level III: 26Gy

SBRT level IV RADIATION

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

SBRT level IV: 28Gy

SBRT level V RADIATION

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

SBRT level V: 30Gy

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitat de les Illes Balears: lead

Study Sites (1)

Hospital Universitario Son Espases

Palma, Balearic Islands, 07120, Spain

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jon Gadea Quinteiro, Principal investigator

  Universitat de les Illes Balears

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Radiation Oncologist

Model Details: 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.

Study Record Dates

• First Submitted: October 28, 2024
• First Posted: November 4, 2024
• Study Start: September 27, 2024
• Primary Completion: September 1, 2025
• Study Completion (Estimated): September 1, 2027
• Last Updated: November 4, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)