Breast CancerNCT05031065
Prognostic Indicators for Radiation-induced Breast Fibrosis
An observational study of Breast Cancer, run by AHS Cancer Control Alberta at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 40 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Breast Cancer Radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 4 participants
- Where
- 1 siteCanada
- Study dates
- 24 Jan 2024to 5 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
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- Uncontrolled intercurrent illness or active infection.
- Patients who have previously received chemotherapy.
- Patients who have previously received chemotherapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Identifying Prognostic Indicators for the Development of Radiation-induced Breast Fibrosis
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Breast Cancer Radiotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast Cancer RadiotherapyRadiation
4000-4250 cGy in 15-16 daily fractions
| Study group | Role | What they receive |
|---|---|---|
| Women undergoing radiation treatment after lumpectomy for breast cancer. | There is no specific study intervention being used. Samples will be collected from participants undergoing standard of care radiotherapy at pre-specified timepoints. Receives: Radiation: Breast Cancer Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measurement of longitudinal changes in plasma LPA in the irradiated breast.
Measured: 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.
Measurement of longitudinal changes in plasma cytokines in the irradiated breast.
Measured: 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.
Measurement of longitudinal changes in plasma chemokines in the irradiated breast.
Measured: Samples will be collected four times during RT treatment (3-4 weeks) and once every 3 months for an year.
Secondary outcomes (3)
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 (%))
Measured: 3, 6, 12, 24 and 48 months after RT
Acute Radiotherapy Toxicity
Radiotherapy associated toxicities will be assessed per CTCAE v5.0 by the study investigators.
Measured: Throughout the duration of the study, a total of 4 years .
Relationship with Cytomegalovirus infection
There is evidence that being infected with Cytomegalovirus is likely to increase the response of the autotaxin-lysophosphatidates inflammatory cycle in response to radiotherapy.
Measured: Seropositivity for CMV will be checked only at baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2021
- Study start24 Jan 2024
- Primary completion5 May 2025
- Study completion5 May 2025
Why it stopped: Loss of Funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- AHS Cancer Control Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zsolt Gabos, MD, Principal investigator, AHS-CCI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05031065
- Sponsor's protocol ID
- IIT-0026
- Status last verified
- Jun 2025
- First submitted
- 25 Aug 2021
- Last updated
- 27 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Prognostic Indicators for the Development of Radiation-induced Breast Fibrosis
- ClinicalTrials.gov ID
- NCT05031065
- Acronym / sponsor ID
- IIT-0026
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Loss of Funding
- Enrolment
- 4 participants (actual)
- Lead sponsor
- AHS Cancer Control AlbertaUniversity, hospital or other
- Study start
- 24 Jan 2024 (actual)
- Primary completion
- 5 May 2025 (actual)
- Study completion
- 5 May 2025 (actual)
- First posted
- 1 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women undergoing radiation treatment after lumpectomy for breast cancer. | – | Radiation: Breast Cancer RadiotherapyThere is no specific study intervention being used. Samples will be collected from participants undergoing standard of care radiotherapy at pre-specified timepoints. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breast Cancer Radiotherapy4000-4250 cGy in 15-16 daily fractions | Radiation | Women undergoing radiation treatment after lumpectomy for breast cancer. |
Primary outcome
Measurement of the ATX-LPA (ATX) inflammatory response to standard RT for breast cancer as a prognostic marker for RT-induced fibrosis.
Time frame: 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.
Time frame: 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.
Measurement of the ATX-LPA-inflammatory (cytokines) response to standard RT for breast cancer as a prognostic marker for RT-induced fibrosis.
Time frame: 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-inflammatory (chemokines) response to standard RT for breast cancer as a prognostic marker for RT-induced fibrosis.
Time frame: 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.
3 secondary outcomes
Structural changes in the irradiated breast and the non-irradiated breast
Time frame: 3, 6, 12, 24 and 48 months after RT
Acute Radiotherapy Toxicity
Time frame: Throughout the duration of the study, a total of 4 years .
Relationship with Cytomegalovirus infection
Time frame: Seropositivity for CMV will be checked only at baseline.
Results and safety
The study was stopped early (reason given: Loss of Funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zsolt Gabos, MD principal investigator
AHS-CCI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by AHS Cancer Control Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Loss of Funding). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of the ATX-LPA (ATX) inflammatory response to standard RT for breast cancer as a prognostic marker for RT-induced fibrosis. (time frame: Samples will be collected four times during RT treatment (3-4 weeks) and once every 3 months for an year.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2025.