Breast CancerSAFE-FORWARDNCT04842409
Safety of Ultra-hypofractionated Whole Breast Irradiation After Breast-conserving Surgery
An observational study of Breast Cancer and Radiotherapy Side Effect, run by Azienda Ospedaliero-Universitaria Careggi at 1 site in Italy.
Trial summary
SAFE-FORWARD is an observational prospective cohort study. Patient population included both invasive and ductal carcinoma in situ (DCIS) breast cancer receiving ultra-hypofractionated whole breast irradiation (26 Gy in 5 fractions) after breast conserving surgery, as per physician choice. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Breast Cancer, Radiotherapy Side Effect
- What is being tested?
- Whole breast irradiation
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 30 Nov 2021to 8 Dec 2022
- 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 18 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients affected by both invasive and ductal carcinoma in situ (DCIS) breast cancer receiving ultra-hypofractionated whole breast irradiation (26 Gy in 5 fractions) after breast conserving surgery, as per physician choice. Adjuvant endocrine therapy as per local policy was allowed. Main exclusion criteria were mastectomy with or without breast reconstruction, neoadjuvant and/or adjuvant chemotherapy, and needs for a tumor bed radiation boost.
Who may be able to join
- Invasive and ductal carcinoma in situ (DCIS) breast cancer
- Indication to ultra-hypofractionated whole breast irradiation
- Written informed consent
- Aged more than 18 years old
Who cannot join
- Neoadjuvant and adjuvant chemotherapy
- Tumor bed radiation boost prescription
Trial locations and contacts
1 site in 1 country.
Italy1 site
Azienda Ospedaliero-Universitaria Careggi, Florence University
Florence, 50134
About this study
Official title: Cardiological Monitoring and Safety of Ultra-hypofractionated Whole Breast Irradiation After Breast-conserving Surgery for Patients Affected by Breast Cancer: an Observational Prospective Cohort Study
SAFE-FORWARD is an observational prospective cohort study. Patient population included both invasive and ductal carcinoma in situ (DCIS) breast cancer receiving ultra-hypofractionated whole breast irradiation (26 Gy in 5 fractions) after breast conserving surgery, as per physician choice. Adjuvant endocrine therapy as per local policy is allowed. Main exclusion criteria are mastectomy with or without breast reconstruction, neoadjuvant and/or adjuvant chemotherapy, and needs for a tumor bed radiation boost.
All enrolled patients will be prospectively monitored for 12 months, receiving a complex cardiological assessment before radiation therapy (RT) start (baseline), and at 2-, 6-, and 12-month after RT end of treatment. Both acute- , defined as adverse events recorded within the first 90 days since RT start, and early-late toxicity, will be scored according to EORTC (European Organisation for Research and Treatment of Cancer)/Radiation Therapy Oncology Group (RTOG) and CTCAE (v.5) scales.
Patients will undergo six-monthly follow-up clinical visits for the first 5 years and annual follow-up visits thereafter up to 10 year, as per clinical local practice. Breast cosmesis will be evaluated through the use of BCCT.core tool and assessment of the health-related quality of life will be performed through the EORTC quality of life questionnaire (QLQ) C30 and BR45 modules questionnaires at baseline, at the end of RT treatment, at 2- and 6-month.
Read the detailed description
This prospective cohort study aims to assess heart toxicity and safety using a 1-week radiation schedule regimen of 26 Gy in five daily fractions.
The primary endpoint was defined as detection of any subclinical impairment in myocardial function and deformation (decrease ≥10%) measured with standard and 3-dimensional (3D) echocardiography and left ventricular (LV) global longitudinal strain (GLS).
Cardiac assessment. Medical history, electrocardiogram (EKG), clinical examination with specific attention to signs of heart failure, New York Heart Association (NYHA) class and Canadian angina grading scale score were recorded during each visit. Transthoracic echocardiography was performed with a commercially available system (EPIQ, X5-1 transducer, Philips Healthcare, Andover, Massachusetts). All measurements were performed and reported accordingly to the American Society of Echocardiography (ASE) and the European Association of Cardiovascular Imaging (EACVI) recommendations. Each measure was averaged over three cardiac cycles. Two-dimensional LVEF (2D-LVEF) was measured by Simpson rule, throughout apical 4- and 2-chamber views. LV mass was calculated from LV oriented M-mode tracings using the Devereux formula, ASE convention, and was indexed to body surface area (BSA). Diastolic function was evaluated by left atrial volume index, systolic pulmonary pressure, mitral inflow E/A pattern, E/A ratio, E velocity deceleration time, annular tissue Doppler e', and E/e' ratio. After optimizing image quality, maximizing frame rate, and minimizing foreshortening, which are all critical to reduce measurement variability, GLS measurements were made in the three standard apical views and averaged. LV 4-, 3-, and 2-chamber views were acquired during breath hold. From apical long-axis view to visualize aortic valve closure, using opening and closing clicks of the aortic valve the timing of aortic valve opening and closing on continuous wave (CW) Doppler imaging respect to EKG R wave was measured. Full-volume six-cycles gated acquisition breath hold images of left ventricle were acquired for Q-lab analysis to obtain end-diastolic volume, end systolic volume, indexed to BSA (EDVI and ESVI) and 3D-LVEF. Q-lab version in this study was 10.5. All echocardiography data was stored including the original Digital Imaging and Communications in Medicine (DICOM) images. All scans were read jointly by two experienced board certified echocardiographers who were blinded to all clinical characteristics. Systemic arterial pressure was measured simultaneously with echo measurements, by means of an arm-cuff sphygmomanometer.
- Conditions
- Breast Cancer, Radiotherapy Side Effect
- Being tested
- Whole breast irradiation
- Keywords
- Breast Cancer, Radiotherapy, Safety
- Medical subject headings
- Breast Neoplasms, Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole breast irradiationRadiation
Whole breast irradiation using an ultra-hypofractionated schedule (26 Gy in 5 fractions)
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline 3-dimensional left ventricular ejection fraction (3D-LVEF) at 12 months
Assessment of 3D-LVEF
Measured: Baseline to 12-month
Change from baseline Global Longitudinal Strain (GLS) at 12 months
Assessment of GLS
Measured: Baseline to 12-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2021
- Study start30 Nov 2021
- Primary completion8 Dec 2022
- Study completion8 Dec 2022
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria Careggi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Icro Meattini, Azienda Ospedaliero-Universitaria Careggi
- Investigators
- Icro Meattini, MD, Prof, Principal investigator, AOU CareggiLorenzo Livi, MD, Prof, Principal investigator, AOU Careggi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04842409
- Sponsor's protocol ID
- SAFE-FORWARD
- Acronym
- SAFE-FORWARD
- Status last verified
- Jul 2023
- First submitted
- 8 Apr 2021
- Last updated
- 20 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiological Monitoring and Safety of Ultra-hypofractionated Whole Breast Irradiation After Breast-conserving Surgery for Patients Affected by Breast Cancer: an Observational Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT04842409
- Acronym / sponsor ID
- SAFE-FORWARD / SAFE-FORWARD
- Conditions
- Breast Cancer, Radiotherapy Side Effect
- Keywords
- Breast Cancer, Radiotherapy, Safety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Azienda Ospedaliero-Universitaria CareggiUniversity, hospital or other
- Study start
- 30 Nov 2021 (actual)
- Primary completion
- 8 Dec 2022 (actual)
- Study completion
- 8 Dec 2022 (actual)
- First posted
- 13 Apr 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.
SAFE-FORWARD is an observational prospective cohort study. Patient population included both invasive and ductal carcinoma in situ (DCIS) breast cancer receiving ultra-hypofractionated whole breast irradiation (26 Gy in 5 fractions) after breast conserving surgery, as per physician choice. Adjuvant endocrine therapy as per local policy is allowed. Main exclusion criteria are mastectomy with or without breast reconstruction, neoadjuvant and/or adjuvant chemotherapy, and needs for a tumor bed radiation boost.
All enrolled patients will be prospectively monitored for 12 months, receiving a complex cardiological assessment before radiation therapy (RT) start (baseline), and at 2-, 6-, and 12-month after RT end of treatment. Both acute- , defined as adverse events recorded within the first 90 days since RT start, and early-late toxicity, will be scored according to EORTC (European Organisation for Research and Treatment of Cancer)/Radiation Therapy Oncology Group (RTOG) and CTCAE (v.5) scales.
Patients will undergo six-monthly follow-up clinical visits for the first 5 years and annual follow-up visits thereafter up to 10 year, as per clinical local practice. Breast cosmesis will be evaluated through the use of BCCT.core tool and assessment of the health-related quality of life will be performed through the EORTC quality of life questionnaire (QLQ) C30 and BR45 modules questionnaires at baseline, at the end of RT treatment, at 2- and 6-month.
Detailed description
This prospective cohort study aims to assess heart toxicity and safety using a 1-week radiation schedule regimen of 26 Gy in five daily fractions.
The primary endpoint was defined as detection of any subclinical impairment in myocardial function and deformation (decrease ≥10%) measured with standard and 3-dimensional (3D) echocardiography and left ventricular (LV) global longitudinal strain (GLS).
Cardiac assessment. Medical history, electrocardiogram (EKG), clinical examination with specific attention to signs of heart failure, New York Heart Association (NYHA) class and Canadian angina grading scale score were recorded during each visit. Transthoracic echocardiography was performed with a commercially available system (EPIQ, X5-1 transducer, Philips Healthcare, Andover, Massachusetts). All measurements were performed and reported accordingly to the American Society of Echocardiography (ASE) and the European Association of Cardiovascular Imaging (EACVI) recommendations. Each measure was averaged over three cardiac cycles. Two-dimensional LVEF (2D-LVEF) was measured by Simpson rule, throughout apical 4- and 2-chamber views. LV mass was calculated from LV oriented M-mode tracings using the Devereux formula, ASE convention, and was indexed to body surface area (BSA). Diastolic function was evaluated by left atrial volume index, systolic pulmonary pressure, mitral inflow E/A pattern, E/A ratio, E velocity deceleration time, annular tissue Doppler e', and E/e' ratio. After optimizing image quality, maximizing frame rate, and minimizing foreshortening, which are all critical to reduce measurement variability, GLS measurements were made in the three standard apical views and averaged. LV 4-, 3-, and 2-chamber views were acquired during breath hold. From apical long-axis view to visualize aortic valve closure, using opening and closing clicks of the aortic valve the timing of aortic valve opening and closing on continuous wave (CW) Doppler imaging respect to EKG R wave was measured. Full-volume six-cycles gated acquisition breath hold images of left ventricle were acquired for Q-lab analysis to obtain end-diastolic volume, end systolic volume, indexed to BSA (EDVI and ESVI) and 3D-LVEF. Q-lab version in this study was 10.5. All echocardiography data was stored including the original Digital Imaging and Communications in Medicine (DICOM) images. All scans were read jointly by two experienced board certified echocardiographers who were blinded to all clinical characteristics. Systemic arterial pressure was measured simultaneously with echo measurements, by means of an arm-cuff sphygmomanometer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients affected by both invasive and ductal carcinoma in situ (DCIS) breast cancer receiving ultra-hypofractionated whole breast irradiation (26 Gy in 5 fractions) after breast conserving surgery, as per physician choice. Adjuvant endocrine therapy as per local policy was allowed. Main exclusion criteria were mastectomy with or without breast reconstruction, neoadjuvant and/or adjuvant chemotherapy, and needs for a tumor bed radiation boost.
Key inclusion criteria (4 listed)
- Invasive and ductal carcinoma in situ (DCIS) breast cancer
- Indication to ultra-hypofractionated whole breast irradiation
- Written informed consent
- Aged more than 18 years old
Key exclusion criteria (2 listed)
- Neoadjuvant and adjuvant chemotherapy
- Tumor bed radiation boost prescription
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 |
|---|---|---|
| Whole breast irradiationWhole breast irradiation using an ultra-hypofractionated schedule (26 Gy in 5 fractions) | Radiation | – |
Primary outcome
Change from baseline 3-dimensional left ventricular ejection fraction (3D-LVEF) at 12 months
Time frame: Baseline to 12-month
Assessment of 3D-LVEF
Change from baseline Global Longitudinal Strain (GLS) at 12 months
Time frame: Baseline to 12-month
Assessment of GLS
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
- 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.
Icro Meattini, MD, Prof principal investigator
AOU Careggi
Lorenzo Livi, MD, Prof principal investigator
AOU Careggi
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 and Radiotherapy Side Effect, run by Azienda Ospedaliero-Universitaria Careggi at 1 site in Italy.
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 4 inclusion and 2 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: finished, as of the sponsor's last update on 20 Jul 2023. 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 Italy. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from baseline 3-dimensional left ventricular ejection fraction (3D-LVEF) at 12 months (time frame: Baseline to 12-month). 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 20 Jul 2023.