Ablative SBRT in Elderly BC Patients

NCT06523894 | Recruiting DMC

• 1 other identifier: BASEC 2024-00824
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Stereotactic body radiotherapy (SBRT) is a modern radiotherapy technique, through which extremely high doses of irradiation are delivered in a very precise manner, within a few fractions. SBRT is increasingly used into clinical practice because it can provide excellent local control, comparable to surgery, in many tumor locations, such as lung, liver or bone. Efforts to develop it for BC treatment are promising, as it is safe, convenient, and effective. To date, SBRT for BC has been developed as an alternative method of partial-breast irradiation (PBI) in the pre- or post-operative setting. Therefore, the doses tested are comparable to the conventional doses used with surgery although its potential as sole local treatment for BC remains unknown. Higher SBRT doses are expected to permit obtaining an ablative effect on tumor and be suitable as an alternative to surgery, but this hypothesis has yet to be tested. The aim of the present study is to prove the feasibility of SBRT as an ablative treatment in early breast cancer (BC). The primary objective is to find the maximum tolerated dose of SBRT that can be safely administered in inoperable patients with BC, the majority of whom are elderly or oldest old. The overall objective is to determine whether high precision, dose- and fractionation- adapted SBRT is feasible and safe in inoperable patients with BC. The dose and fractionation-adapted SBRT regimen permits to test feasibility in different tumor sizes. The primary objective of this study is to establish the maximum tolerated dose (MTD) that can be delivered with a single or few (up to 5) fractions of SBRT in inoperable patients with BC.

Conditions

Breast Cancer

Keywords

radiotherapy; SBRT; inoperable

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose (MTD)

  Dose before the dose-level at which one or more dose-limiting toxicity (DLT) (any treatment-related toxicity equal or superior to Grade 3, according to CTCAE v5) occurs within 4 weeks after end of study treatment (EOT).

  4 weeks

Secondary Outcomes (7)

• Early and late toxicities

  2 years

• Differential safety profile between arms

  2 years

• Explorative: clinically relevant technical parameters of SBRT

  2 years

• Efficacy o SBRT on local control

  2 years

• Explorative: Time to local, regional and distant progression

  2 years

Study Arms (3)

1 fraction SBRT

EXPERIMENTAL

Treated volume up to 40 cc. Dose escalation from 21 Gy to 23 Gy to 25 Gy every 3 patients if no dose-limiting toxicity (DLT).

Radiation: SBRT

3 fractions SBRT

EXPERIMENTAL

Treated volume up to 60 cc. Dose escalation from 11Gy/fraction to 13Gy/fraction to 14Gy/fraction every 3 patients if no dose-limiting toxicity (DLT).

Radiation: SBRT

5 fractions SBRT

EXPERIMENTAL

Treated volume up to 110 cc. Dose escalation from 8Gy/fraction to 9Gy/fraction to 10Gy/fraction every 3 patients if no dose-limiting toxicity (DLT).

Radiation: SBRT

Interventions

SBRT RADIATION

Adapted to tumor volume BC SBRT

1 fraction SBRT; 3 fractions SBRT; 5 fractions SBRT

Eligibility Criteria

• Age: 70 Years+
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age over 70 years
• Histologically confirmed diagnosis of BC, any time before study enrollment.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 3.
• Patient considered inoperable in multidisciplinary board decision or refusing surgery. Main criteria determining inoperability are inability to receive general anesthesia after anesthetics and/or surgical evaluation. Criteria described in the statement of American Society of Anesthesiologists (ASA) {, #4699} and American College of Surgeons Surgical risk calculators {, #4695} are usually addressed in the multidisciplinary discussion (Appendix ).
• Presence of measurable disease in the breast, defined as a lesion that can be accurately measured in at least one dimension with imaging (ultrasound, CT or MRI). Disease in the axilla or internal mammary chain is allowed and will be treated at the discretion of the radiation oncologist. Regional disease is not considered in measurements of local response.
• Primary tumor accessible to SBRT, as defined by treating radiation oncologist.
• Neo-adjuvant systemic therapy is allowed.
• Tumor size in planning computed tomography (CT) permitting SBRT delivery. SBRT appropriateness is defined by the treating radiation oncologist.
• Multifocality (over two tumor foci within the same breast quadrant) is allowed, as long as the total treatment volumes remain suitable for SBRT, as defined by the treating radiation oncologist.
• Total tumor treatment volume/ whole breast volume ratio not exceeding 30%.
• Previous treatment for BC to the contralateral breast is allowed. Previous treatment to the same breast for other reason than BC is allowed.
• Capacity of patient to collaborate for SBRT delivery.
• Capacity of patient to understand and sign a written informed consent according to International Council for Harmonization (ICH)/Good Clinical Practice (GCP) regulations before registration.

You may not qualify if:

• Prior surgery for the current diagnosis.
• Prior whole or partial breast irradiation to the involved breast.
• Absolute contraindication to RT, such as Li-Fraumeni syndrome.
• Current participation and receipt of study therapy or previous participation in a study of an investigational agent and receipt of study therapy or used an investigation device within 4 weeks of the first day of treatment.
• Not able to communicate meaningfully with investigator and site staff and/or incapable of discernment.
• Any other serious underlying medical, psychiatric, psychological, familial or geographical condition, which in the judgment of the investigator may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications.

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (1)

Radiation Oncology Department, Geneva University Hospital

Geneva, 1205, Switzerland

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Pelagia Tsoutsou, Pr

  Radiation Oncology Department, Geneva University Hospital

  STUDY CHAIR

Central Study Contacts

Pelagia Tsoutsou, Pr

CONTACT

0795534630; pelagia.tsoutsou@hug.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Radiation Oncology Department

Model Details: Phase Ia/Ib

Study Record Dates

• First Submitted: July 12, 2024
• First Posted: July 26, 2024
• Study Start: March 25, 2025
• Primary Completion (Estimated): March 25, 2028
• Study Completion (Estimated): March 25, 2029
• Last Updated: May 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)