Ablative SBRT for elderly patients with inoperable breast cancer

EASE (brEAst Stereo Elderly): A Phase Ia/Ib Study of Stereotactic Ablative Irradiation as an Alternative to Surgery in Elderly and Comorbid Breast Cancer Subjects

This study will try high-dose, very focused radiation (SBRT) as the only local treatment for elderly patients with inoperable or surgery-refusing breast cancer.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 36 (estimated)
• Ages: 70 Years and up
• Sex: Female
• Sponsor: University Hospital, Geneva (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Geneva)
• Trial ID: NCT06523894 on ClinicalTrials.gov

What this trial studies

This feasibility trial delivers high-dose stereotactic body radiotherapy (SBRT) to breast tumors using LINAC platforms (TrueBeam or CyberKnife) with volumetric arc or non-coplanar techniques. Treatment plans target the gross tumor volume (GTV) with small isotropic margins (1–3 mm depending on device) and include an elective 2 cm clinical target volume (CTV) around the GTV, with adaptive fractionation in 1, 3, or 5 fractions based on tumor size. Organs at risk are contoured per international guidelines and planning target volumes are cropped from skin and chest wall to limit toxicity. Patients aged over 70 who are inoperable or refuse surgery will be followed for local control and safety to determine feasibility of SBRT as a sole local therapy.

Who should consider this trial

Good fit: Ideal candidates are patients aged over 70 with histologically confirmed, measurable breast cancer who are deemed inoperable or decline surgery and have ECOG performance status 0–3.

Not a fit: Patients with widespread metastatic disease, multicentric tumors unsuitable for focal treatment, or those who are good surgical candidates with acceptable perioperative risk are less likely to benefit.

Why it matters

Potential benefit: If successful, this could provide a non-surgical, short-course curative option for elderly patients who cannot or will not undergo surgery.

How similar studies have performed: SBRT has shown good local control when used for partial-breast irradiation in pre- or post-operative settings, but high-dose ablative SBRT as the sole treatment for breast cancer remains largely untested.

Eligibility criteria

Inclusion Criteria:

1. Age over 70 years
2. Histologically confirmed diagnosis of BC, any time before study enrollment.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 3.
4. 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 ).
5. 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.
6. Primary tumor accessible to SBRT, as defined by treating radiation oncologist.
7. Neo-adjuvant systemic therapy is allowed.
8. Tumor size in planning computed tomography (CT) permitting SBRT delivery. SBRT appropriateness is defined by the treating radiation oncologist.
9. 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.
10. Total tumor treatment volume/ whole breast volume ratio not exceeding 30%.
11. Previous treatment for BC to the contralateral breast is allowed. Previous treatment to the same breast for other reason than BC is allowed.
12. Capacity of patient to collaborate for SBRT delivery.
13. 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.

Exclusion Criteria:

1. Prior surgery for the current diagnosis.
2. Prior whole or partial breast irradiation to the involved breast.
3. Absolute contraindication to RT, such as Li-Fraumeni syndrome.
4. 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.
5. Not able to communicate meaningfully with investigator and site staff and/or incapable of discernment.
6. 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.

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Where this trial is running

Geneva

• Radiation Oncology Department, Geneva University Hospital — Geneva, Switzerland (Recruiting)

Study contacts

• Study coordinator: Pelagia Tsoutsou, Pr

Conditions Breast Cancer; radiotherapy; SBRT; inoperable