Prognostic Indicators for Radiation-induced Breast Fibrosis

Recruiting

• Conditions: Breast Cancer
• Interventions: Radiation: Breast Cancer Radiotherapy

• Registration Number: NCT05031065
• Lead Sponsor: AHS Cancer Control Alberta

Brief Summary

To study the inflammatory response during and after radiotherapy, especially by measuring the concentration of an enzyme called autotaxin and its product LPA in the blood plasma.

Detailed Description

To study the inflammatory response during and after radiotherapy, especially by measuring the concentration of an enzyme called autotaxin and its product LPA in the blood plasma. Autotaxin and LPA cause fibrosis in other situation, but they have not been tested in radiation-induced fibrosis. We will determine if the duration and magnitude of the autotaxin and LPA responses are prognostic for the 15-28% of patients who will develop fibrosis. This fibrosis will be detected by ultrasound and a novel application of elastography, which should provide much earlier and quantifiable fibrotic changes compared to conventional physical examination.

Study Timeline

• Study First Submitted: 2021-08-25
• Study First Submitted QC: 2021-08-30
• Study First Posted: 2021-09-01
• Study Start: 2024-01-24
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-21
• Last Update Posted: 2024-06-24
• Primary Completion: 2025-07
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 27

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Women undergoing radiation treatment after lumpectomy for breast cancer.	Breast Cancer Radiotherapy	There is no specific study intervention being used. Samples will be collected from participants undergoing standard of care radiotherapy at pre-specified timepoints.

Primary Outcome Measures

Name	Time	Method
Measurement of the ATX-LPA-inflammatory (chemokines) response to standard RT for breast cancer as a prognostic marker for RT-induced fibrosis.	Samples will be collected four times during RT treatment (3-4 weeks) and once every 3 months for an year.	Measurement of longitudinal changes in plasma chemokines in the irradiated breast.
Measurement of the ATX-LPA-inflammatory (cytokines) response to standard RT for breast cancer as a prognostic marker for RT-induced fibrosis.	Samples will be collected four times during RT treatment (3-4 weeks) and once every 3 months for an year.	Measurement of longitudinal changes in plasma cytokines in the irradiated breast.
Measurement of the ATX-LPA (ATX) inflammatory response to standard RT for breast cancer as a prognostic marker for RT-induced fibrosis.	Samples will be collected four times during RT treatment (3-4 weeks) and once every 3 months for an year.	Measurement of longitudinal changes in plasma ATX in the irradiated breast.
Measurement of the ATX-LPA-inflammatory (LPA) response to standard RT for breast cancer as a prognostic marker for RT-induced fibrosis.	Samples will be collected four times during RT treatment (3-4 weeks) and once every 3 months for an year.	Measurement of longitudinal changes in plasma LPA in the irradiated breast.

Secondary Outcome Measures

Name	Time	Method
Structural changes in the irradiated breast and the non-irradiated breast	3, 6, 12, 24 and 48 months after RT	The ultrasound procedure will provide a 3D analysis of the breast structure as well as a measurement of breast elasticity. Fibrotic changes in the breast will be measured by combining the 3D analysis and breast elasticity indices (median (kPa), IQR (kPA) and IQR/median (%))
Acute Radiotherapy Toxicity	Throughout the duration of the study, a total of 4 years .	Radiotherapy associated toxicities will be assessed per CTCAE v5.0 by the study investigators.
Relationship with Cytomegalovirus infection	Seropositivity for CMV will be checked only at baseline.	There is evidence that being infected with Cytomegalovirus is likely to increase the response of the autotaxin-lysophosphatidates inflammatory cycle in response to radiotherapy.

Trial Locations

Locations (1)

Cross Cancer Institute; 🇨🇦 Edmonton, Alberta, Canada