Prognostic Indicators for Radiation-induced Breast Fibrosis

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05031065
• Other study ID #: IIT-0026
• Status: Recruiting
• Start date: January 24, 2024
• Est. completion date: December 2026

Study information

• Verified date: January 2024
• Source: AHS Cancer Control Alberta
• Contact: Zsolt Gabos, MD
• Phone: 780-432-8783
• Email: Zsolt.Gabos[@]ahs.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 27
• Est. completion date: December 2026
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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. Post-menopausal.

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.

Related Conditions & MeSH terms

• Breast Cancer
• Fibrosis

Intervention

Radiation:
• Breast Cancer Radiotherapy
4000-4250 cGy in 15-16 daily fractions

Locations

Country	Name	City	State
Canada	Cross Cancer Institute	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
AHS Cancer Control Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of the ATX-LPA (ATX) inflammatory response to standard RT for breast cancer as a prognostic marker for RT-induced fibrosis.	Measurement of longitudinal changes in plasma ATX in the irradiated breast.	Samples will be collected four times during RT treatment (3-4 weeks) and once every 3 months for an year.
Primary	Measurement of the ATX-LPA-inflammatory (LPA) response to standard RT for breast cancer as a prognostic marker for RT-induced fibrosis.	Measurement of longitudinal changes in plasma LPA in the irradiated breast.	Samples will be collected four times during RT treatment (3-4 weeks) and once every 3 months for an year.
Primary	Measurement of the ATX-LPA-inflammatory (cytokines) response to standard RT for breast cancer as a prognostic marker for RT-induced fibrosis.	Measurement of longitudinal changes in plasma cytokines in the irradiated breast.	Samples will be collected four times during RT treatment (3-4 weeks) and once every 3 months for an year.
Primary	Measurement of the ATX-LPA-inflammatory (chemokines) response to standard RT for breast cancer as a prognostic marker for RT-induced fibrosis.	Measurement of longitudinal changes in plasma chemokines in the irradiated breast.	Samples will be collected four times during RT treatment (3-4 weeks) and once every 3 months for an year.
Secondary	Structural changes in the irradiated breast and the non-irradiated breast	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 (%))	3, 6, 12, 24 and 48 months after RT
Secondary	Acute Radiotherapy Toxicity	Radiotherapy associated toxicities will be assessed per CTCAE v5.0 by the study investigators.	Throughout the duration of the study, a total of 4 years .