Clinical trial NCT05031065: Prognostic Indicators for Radiation-induced Breast Fibrosis
Official title: Identifying Prognostic Indicators for the Development of Radiation-induced Breast Fibrosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Lead sponsor: AHS Cancer Control Alberta
Sponsor class: OTHER
First posted: 2021-09-01
Enrollment: 27
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We will study a low risk group of 27 post-menopausal patients with luminal A breast cancer after they have received breast conserving surgery (lumpectomy). Women who have smoked or received chemotherapy will be excluded to minimize variables.

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.

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.

Primary outcomes:
measure: Measurement of the ATX-LPA (ATX) inflammatory response to standard RT for breast cancer as a prognostic marker for RT-induced fibrosis.
timeFrame: Samples will be collected four times during RT treatment (3-4 weeks) and once every 3 months for an year.
measure: Measurement of the ATX-LPA-inflammatory (LPA) response to standard RT for breast cancer as a prognostic marker for RT-induced fibrosis.
timeFrame: Samples will be collected four times during RT treatment (3-4 weeks) and once every 3 months for an year.
measure: Measurement of the ATX-LPA-inflammatory (cytokines) response to standard RT for breast cancer as a prognostic marker for RT-induced fibrosis.
timeFrame: Samples will be collected four times during RT treatment (3-4 weeks) and once every 3 months for an year.
measure: Measurement of the ATX-LPA-inflammatory (chemokines) response to standard RT for breast cancer as a prognostic marker for RT-induced fibrosis.
timeFrame: Samples will be collected four times during RT treatment (3-4 weeks) and once every 3 months for an year.
Secondary outcomes:
measure: Structural changes in the irradiated breast and the non-irradiated breast
timeFrame: 3, 6, 12, 24 and 48 months after RT
measure: Acute Radiotherapy Toxicity
timeFrame: Throughout the duration of the study, a total of 4 years .
measure: Relationship with Cytomegalovirus infection
timeFrame: Seropositivity for CMV will be checked only at baseline.
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
Study officials:
affiliation: AHS-CCI
name: Zsolt Gabos, MD
role: PRINCIPAL_INVESTIGATOR
References: