TerminatedNot Applicable

Prognostic Indicators for Radiation-induced Breast Fibrosis

Stopped: Loss of Funding

Canada4 participantsStarted 2024-01-24

Plain-language 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.

Who can participate

Age range40 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

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

Exclusion criteria

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

What they're measuring

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.

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.

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.

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.

Trial details

NCT IDNCT05031065

SponsorAHS Cancer Control Alberta

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-05-05

View on ClinicalTrials.gov More Breast Cancer trials

Who can participate

Age range40 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

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

Exclusion criteria

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