Investigating factors that predict breast fibrosis after radiation therapy

Identifying Prognostic Indicators for the Development of Radiation-induced Breast Fibrosis

This study is testing whether measuring certain substances in the blood can help predict if breast cancer patients will develop fibrosis after radiation therapy.

Quick facts

• Study type: Observational
• Enrollment: 27 (estimated)
• Ages: 40 Years and up
• Sex: Female
• Sponsor: AHS Cancer Control Alberta (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Edmonton, Alberta)
• Trial ID: NCT05031065 on ClinicalTrials.gov

What this trial studies

This observational study aims to analyze the inflammatory response in breast cancer patients undergoing radiotherapy by measuring the levels of an enzyme called autotaxin and its product, LPA, in blood plasma. The study will assess whether the duration and magnitude of these responses can predict the development of radiation-induced fibrosis, which affects 15-28% of patients. Fibrosis will be detected using ultrasound and a novel elastography technique, allowing for earlier and more quantifiable identification of fibrotic changes compared to traditional examinations.

Who should consider this trial

Good fit: Ideal candidates are women aged 40 and above with luminal A subtype breast cancer who are undergoing breast conserving surgery and planned for adjuvant whole breast radiotherapy.

Not a fit: Patients who have smoked in the last 5 years, require adjuvant chemotherapy, or have other specific exclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved prognostic tools for identifying patients at risk of developing radiation-induced breast fibrosis.

How similar studies have performed: While studies have explored inflammatory responses in other contexts, this specific approach to radiation-induced fibrosis is relatively novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

1. Female participants capable of giving informed consent, or if appropriate, participants having an acceptable individual capable of giving consent on the participant's behalf
2. Age 40 and above.
3. Treatment with breast conserving surgery.
4. Intended adjuvant whole breast radiotherapy dose to a dose of 40-42.5 Gy in 15-16 fractions.
5. Luminal A subtype as determined by clinipathologic factors (ER/PR positive, Her-2 negative, low Ki-67 or low OncotypeDx recurrence score

Exclusion Criteria:

1. Women who have smoked within the last 5 years
2. Patients requiring adjuvant chemotherapy.
3. Requirement for regional nodal radiotherapy.
4. Requirement for tumour bed boost.
5. Breast implants
6. Patients to be treated with partial breast irradiation.
7. Uncontrolled intercurrent illness or active infection.
8. Patients who have previously received chemotherapy.
9. Patients who have previously received chemotherapy.

Where this trial is running

Edmonton, Alberta

• Cross Cancer Institute — Edmonton, Alberta, Canada (Recruiting)

Study contacts

• Principal investigator: Zsolt Gabos, MD — Ahs-Cci
• Study coordinator: Zsolt Gabos, MD

Conditions Breast Cancer