Breast CancerPhase 2IORT_BREASTNCT05498311
Breast Cancer With Intraoperative Radiotherapy Followed by Hypofractionated External Beam Radiotherapy
A Phase 2 study testing Intraoperative Radiotherapy (IORT), Breast conservative surgery and External Beam Hypofractionated Radiotherapy (EBRT) in people with Breast Cancer, run by Institut Català d'Oncologia at 1 site in Spain.
Trial summary
To evaluate cosmetic outcomes after conservative surgery for breast cancer with INTRABEAM followed by hypofractionated external beam radiotherapy Read more about this study
- Who is it for?
- Ages 45 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Intraoperative Radiotherapy (IORT), Breast conservative surgery and External Beam Hypofractionated Radiotherapy (EBRT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteSpain
- Study dates
- 20 Oct 2016to Dec 2024
- Phase
- Phase 2
- 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 45 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Histologically-confirmed diagnosis of invasive breast carcinoma and eligibility for conservative surgery (with or without oncoplastic surgery) and radiotherapy.
- Not pregnant at diagnosis.
- Signed informed consent form.
- Age ≥45 years old.
- Patients candidates to Intrabeam.
- Patients with ≥60 years with the presence of one or more of the following adverse criteria after surgery:
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- Tumor size > 2.5 cm.
- Extensive intraductal carcinoma (≥25%)
- Lymphovascular invasion.
- Involved focal margins (<2mm) without ampliation surgery.
Who cannot join
- Presence of distant metastasis.
- Primary chemotherapy.
- Lymph node involvement.
- Negative hormonal receptors.
- Diagnosis of any other infiltrating tumour except for adequately resected squamous or basal cell epitheliomas
- Patients with collagen vascular disease (systemic lupus erythematosus, scleroderma, dermatomyositis).
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- Uncontrolled infection.
- Concurrent treatment with other experimental treatments
- Lack of signed informed consent form.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Evelyn Martínez
L'Hospitalet de Llobregat, Barcelona, 08908
Evelyn Martínez, MD, +34 93 260 77 20, emperez@iconcologia.net
About this study
Official title: Cosmetic Outcomes Following Conservative Surgery (With or Without Oncoplastic Surgery) for Breast Cancer With Intraoperative Radiotherapy (INTRABEAM) Followed by Hypofractionated External Beam Radiotherapy: a Phase II Trial
To evaluate cosmetic outcomes after conservative surgery for breast cancer with INTRABEAM followed by hypofractionated external beam radiotherapy
Read the detailed description
To evaluate cosmetic outcomes following conservative surgery (with or without oncoplastic surgery) for breast cancer with intraoperative radiotherapy (INTRABEAM) followed by hypofractionated external beam radiotherapy
- Conditions
- Breast Cancer
- Being tested
- Intraoperative Radiotherapy (IORT), Breast conservative surgery, External Beam Hypofractionated Radiotherapy (EBRT)
- Keywords
- Intraoperative radiotherapy, hypofractionated 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.
Intraoperative Radiotherapy (IORT)Radiation
The Intrabeam Photon Radiosurgery System will deliver 20 Gy in the act of breast surgery
Breast conservative surgeryProcedure or surgery
Breast conservative surgery with the aim of resecting breast tumour and with or without oncoplastic surgery
External Beam Hypofractionated Radiotherapy (EBRT)Radiation
A External Beam Hypofractionated Radiotherapy will be administered after surgery. y. The dose per fraction will be 2.67 Gy per session. EBRT will be performed daily from Monday to Friday for fifteen fractions.
| Study group | Role | What they receive |
|---|---|---|
| Intraoperative Radiotherapy (IORT) | Experimental | Patients with diagnosis of invasive breast cancer (IBC) will be treated with conservative surgery (with or without oncoplastic surgery) and 20 Gy IORT followed by hypofractionated radiotherapy. Receives: Radiation: Intraoperative Radiotherapy (IORT); Procedure: Breast conservative surgery; Radiation: External Beam Hypofractionated Radiotherapy (EBRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Cosmetic results - BCCT
It will be measured by the BCCT.core software programme. This software uses 4 photographies of the breast for each timepoint and evaluates cosmetic outcome based upon symmetry, skin colour changes and surgical scar appearance. The lower the calculated score, the better the cosmetic outcome (1=excellent, 2=good, 3=fair, 4=poor)
Measured: Baseline and every 12 months until 60 months
Changes in Cosmetic results - Self Evaluation using YBT
Questionnaire for cosmetic self-evaluation from the Young Boost Trial (YBT) that consists s of 8 questions about various aspects (size, shape, skin colour, massiveness of the breast, nipple position, general appearance, visibility of the surgical scar, and overall satisfaction) to evaluate the degree of satisfaction of the patients themselves about the cosmetic results.
Measured: Baseline and every 12 months until 60 months
Secondary outcomes (4)
Changes in Quality of life (QOL) - General
It will be measured by the European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaires QLQ-C30
Measured: Baseline and every 12 months until 60 months
Toxicity (acute and late)
Defined according to the NCI criteria published in the Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Measured: Baseline and every 12 months until 60 months
Local control
Defined as histologically-confirmed evidence of tumour recurrence in the ipsilateral breast
Measured: Baseline and every 3 months after completion of EBRT and thereafter every 6 months for 5 years
Changes in Quality of life (QOL) - Breast
It will be measured by the European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaires QLQ-BR23
Measured: Baseline and every 12 months until 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2022
- Study start20 Oct 2016
- Primary completionDec 2023 (estimated)
- Study completionDec 2024 (estimated)
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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Intraoperative Radiotherapy (IORT)
- Masking
- None (open label)
- Enrolment
- 89 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Català d'Oncologia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Evelyn Martínez, MD, Principal investigator, Institut Català d'Oncologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05498311
- Sponsor's protocol ID
- IORT BREAST CANCER
- Acronym
- IORT_BREAST
- Status last verified
- Aug 2022
- First submitted
- 8 Apr 2021
- Last updated
- 15 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cosmetic Outcomes Following Conservative Surgery (With or Without Oncoplastic Surgery) for Breast Cancer With Intraoperative Radiotherapy (INTRABEAM) Followed by Hypofractionated External Beam Radiotherapy: a Phase II Trial
- ClinicalTrials.gov ID
- NCT05498311
- Acronym / sponsor ID
- IORT_BREAST / IORT BREAST CANCER
- Conditions
- Breast Cancer
- Keywords
- Intraoperative radiotherapy, hypofractionated radiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 89 participants (estimated)
- Lead sponsor
- Institut Català d'OncologiaUniversity, hospital or other
- Study start
- 20 Oct 2016 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 12 Aug 2022 (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 evaluate cosmetic outcomes after conservative surgery for breast cancer with INTRABEAM followed by hypofractionated external beam radiotherapy
Detailed description
To evaluate cosmetic outcomes following conservative surgery (with or without oncoplastic surgery) for breast cancer with intraoperative radiotherapy (INTRABEAM) followed by hypofractionated external beam radiotherapy
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Intraoperative Radiotherapy (IORT)
| Arm | Type | Receives |
|---|---|---|
| Intraoperative Radiotherapy (IORT) | Experimental | Radiation: Intraoperative Radiotherapy (IORT), Procedure: Breast conservative surgery, Radiation: External Beam Hypofractionated Radiotherapy (EBRT)Patients with diagnosis of invasive breast cancer (IBC) will be treated with conservative surgery (with or without oncoplastic surgery) and 20 Gy IORT followed by hypofractionated radiotherapy. |
Who may qualify
- Ages
- 45 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically-confirmed diagnosis of invasive breast carcinoma and eligibility for conservative surgery (with or without oncoplastic surgery) and radiotherapy.
- Not pregnant at diagnosis.
- Signed informed consent form.
- Age ≥45 years old.
- Patients candidates to Intrabeam.
Key exclusion criteria (9 listed)
- Presence of distant metastasis.
- Primary chemotherapy.
- Lymph node involvement.
- Negative hormonal receptors.
- Diagnosis of any other infiltrating tumour except for adequately resected squamous or basal cell epitheliomas
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 |
|---|---|---|
| Intraoperative Radiotherapy (IORT)The Intrabeam Photon Radiosurgery System will deliver 20 Gy in the act of breast surgery | Radiation | Intraoperative Radiotherapy (IORT) |
| Breast conservative surgeryBreast conservative surgery with the aim of resecting breast tumour and with or without oncoplastic surgery | Procedure or surgery | Intraoperative Radiotherapy (IORT) |
| External Beam Hypofractionated Radiotherapy (EBRT)A External Beam Hypofractionated Radiotherapy will be administered after surgery. y. The dose per fraction will be 2.67 Gy per session. EBRT will be performed daily from Monday to Friday for fifteen fractions. | Radiation | Intraoperative Radiotherapy (IORT) |
Primary outcome
Changes in Cosmetic results - BCCT
Time frame: Baseline and every 12 months until 60 months
It will be measured by the BCCT.core software programme. This software uses 4 photographies of the breast for each timepoint and evaluates cosmetic outcome based upon symmetry, skin colour changes and surgical scar appearance. The lower the calculated score, the better the cosmetic outcome (1=excellent, 2=good, 3=fair, 4=poor)
Changes in Cosmetic results - Self Evaluation using YBT
Time frame: Baseline and every 12 months until 60 months
Questionnaire for cosmetic self-evaluation from the Young Boost Trial (YBT) that consists s of 8 questions about various aspects (size, shape, skin colour, massiveness of the breast, nipple position, general appearance, visibility of the surgical scar, and overall satisfaction) to evaluate the degree of satisfaction of the patients themselves about the cosmetic results.
4 secondary outcomes
Changes in Quality of life (QOL) - General
Time frame: Baseline and every 12 months until 60 months
Toxicity (acute and late)
Time frame: Baseline and every 12 months until 60 months
Local control
Time frame: Baseline and every 3 months after completion of EBRT and thereafter every 6 months for 5 years
Changes in Quality of life (QOL) - Breast
Time frame: Baseline and every 12 months until 60 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2022.
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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.
Evelyn Martínez, MD principal investigator
Institut Català d'Oncologia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intraoperative Radiotherapy (IORT), Breast conservative surgery and External Beam Hypofractionated Radiotherapy (EBRT) in people with Breast Cancer, run by Institut Català d'Oncologia at 1 site in Spain.
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 10 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: status not confirmed, as of the sponsor's last update on 15 Aug 2022. 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 Spain. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Evelyn Martínez, MD (+34 93 260 77 20, emperez@iconcologia.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Cosmetic results - BCCT (time frame: Baseline and every 12 months until 60 months). The study lists 2 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 15 Aug 2022.