SABR PRIMER - Evaluating Stereotactic Ablative Radiotherapy for Primary and Regional Breast Tumors

NCT06937281 | Not Yet Recruiting

• 1 other identifier: H25-00274
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The study is being done to determine if stereotactic ablative radiotherapy (SABR) can control tumour growth for patients with metastatic breast cancer. Secondary objectives will be overall survival, progression-free survival and time to switch of next line of systemic therapy. Radiation-related adverse events will be assess, with a specific focus on dermatitis, lymphedema and brachial plexopathy. The exploratory objective is to correlate toxicities and outcomes with peripheral blood biomarkers and circulating tumor DNA to potentially help predict responses in future patients receiving combined therapy.

Conditions

Breast Cancer; Metastases

Keywords

SABR

Outcome Measures

Primary Outcomes (1)

• Locoregional Control

  Assess median, 1-year and 2-year locoregional control

  2 Years

Secondary Outcomes (4)

• Overall survival

  2 Years

• Progression Free Survival

  2 Years

• systemic therapy switch

  2 Years

• Adverse Events

  2 Years

Study Arms (1)

Treatment

EXPERIMENTAL

SABR treatment to Whole breast +/- regional lymph nodes

Radiation: SABR

Interventions

SABR RADIATION

Prescription dose/fractionation: 26Gy/5 with 40Gy/5 +/- 35Gy/5 Boost Radiation Technique: VMAT Treatment Frequency: Every other day (EOD)

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologically confirmed AJCC 7th/8th edition Stage IV invasive ductal carcinoma or invasive lobular carcinoma of the breast.
• Measurable disease in the breast, suitable to receive radiotherapy.
• Receiving or planned to receive systemic therapy.
• a. The following should be held for the duration of treatment: cytotoxic chemotherapy, CDK4/6 inhibitors, T-DXd
• Patients are allowed to have SABR for oligometastatic disease as clinically indicated
• Age 18 or older
• ECOG Performance Status 0-2
• Life expectancy greater than 6 months
• Able and willing to provide informed consent
• Able to complete patient reported outcome questionnaires

You may not qualify if:

• Contraindications to radiotherapy, including a history of SLE, systemic scleroderma, IPF, ataxia telangiectasia, pregnancy
• Previous history of locoregional radiotherapy to the ipsilateral breast

Sponsors & Collaborators

• British Columbia Cancer Agency: lead

Study Sites (1)

BC Cancer - Vancouver

Vancouver, British Columbia, V5Z 4E6, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Sandy Chang

CONTACT

6048776000; sandy.chang@bccancer.bc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A retrospective study will be conducted to create a matched cohort to compare locoregional control rates with patients who received conventional fractionated radiotherapy.

Study Record Dates

• First Submitted: April 15, 2025
• First Posted: April 22, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): July 30, 2030
• Last Updated: April 24, 2025

Record last verified: 2025-04

Locations

CA (1)