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

B

British Columbia Cancer Agency

Status

Not yet enrolling

Conditions

Breast Cancer
Metastases

Treatments

Radiation: SABR

Study type

Interventional

Funder types

Other

Identifiers

NCT06937281
H25-00274

Details and patient eligibility

About

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.

Full description

Purpose:

The purpose of this study is to determine if stereotactic ablative radiotherapy (SABR) can provide effective locoregional control for patients with metastatic breast cancer. As secondary objectives, the investigators will assess the overall survival, progression-free survival and time to switch of next line of systemic therapy. The investigators will also assess radiation-related adverse events using CTCAE v5.0, with a specific focus on dermatitis, lymphedema and brachial plexopathy. Finally, as an exploratory objective, the investigators aim to correlate toxicities and outcomes with peripheral blood biomarkers and circulating tumor DNA to potentially help predict responses in future patients receiving combined therapy.

Primary Objective:

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

Secondary Objectives:

  • Assess median, 1-year and 2-year overall survival
  • Assess median, 1-year and 2-year progression-free survival
  • Assess median time to systemic therapy switch
  • Assess radiation-related adverse events using CTCAE v5.0

Correlative Objectives:

• Correlate outcomes with peripheral blood-derived parameters

Research Design The trial is designed as a single-arm interventional study investigating stage IV breast cancer with persistent or progressive locoregional disease despite the use of standard systemic therapy A retrospective study will be conducted to create a matched cohort to compare locoregional control rates with patients who received conventional fractionated radiotherapy.

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Pathologically confirmed AJCC 7th/8th edition Stage IV invasive ductal carcinoma or invasive lobular carcinoma of the breast.

  2. Measurable disease in the breast, suitable to receive radiotherapy.

  3. 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

  4. Patients are allowed to have SABR for oligometastatic disease as clinically indicated

  5. Age 18 or older

  6. ECOG Performance Status 0-2

  7. Life expectancy greater than 6 months

  8. Able and willing to provide informed consent

  9. Able to complete patient reported outcome questionnaires

Exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

40 participants in 1 patient group

Treatment
Experimental group
Description:
SABR treatment to Whole breast +/- regional lymph nodes
Treatment:
Radiation: SABR

Trial contacts and locations

1

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Central trial contact

Sandy Chang

Data sourced from clinicaltrials.gov

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