Breast Cancer FemaleNCT05358093
Cardiac Toxicity of Hypo Fractionated Radiotherapy in Left Breast Cancer
An observational study of Breast Cancer Female, run by Assiut University.
Trial summary
Worldwide, Breast cancer is the most common cancer in women,where 1.7 million new cases diagnosed in 2012 . In 2020 number doubled as 2.3 million women diagnosed with breast cancer. According to ACS 1 in 8 women in United states will develop breast cancer in her life . Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer Female
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 27 Apr 2022to 30 Nov 2023
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: female with left breast cancer
Who may be able to join
- 1. Age 18-75 years old 2. histopathology diagnosed 3. Left sided breast cancer 4. Receiving 3D hypofractionated radiotherapy 5. Patients should be non metastatic 6. performance status 0-2
Who cannot join
- • Patient > 75 years old
- Non histological diagnosed
- Metastatic patient
- Patient with cardiac or other co morbidity.
- ECoG performance status >2
- pregnant or lactating patients
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Retrospective Study of Cardiac Toxicity of Hypo Fractionated Radiotherapy in Left Breast Cancer
Worldwide, Breast cancer is the most common cancer in women,where 1.7 million new cases diagnosed in 2012 . In 2020 number doubled as 2.3 million women diagnosed with breast cancer. According to ACS 1 in 8 women in United states will develop breast cancer in her life .
Similarly again, In Egypt breast cancer is the most common malignancy in women about 22,700 new cases recorded in 2020. Accounting for 38.8% of cancers in this population and forecasted to be approximately 46,000 in 2050 .
Read more
Post-operative radiotherapy is fundamental part of treatment after either conservative surgery or mastectomy . Conventionally fractionated radiation therapy (CFRT) ,Delivering 45-50 GY in 1.8-2 GY daily fractions for 5 days per week over 5-7 weeks was the standard schedule to eradicate sub clinical disease ,sparing normal tissues .After the publication of long term results of randomized controlled trials (RCTs) comparing safety and effectiveness of hypo fractionated RT (HFRT)delivered in3 weeks ,vs. CFRT in node negative BC has been implemented . in 2008 numerous international guidelines recommended HFRT as the new standard being Cost effectiveness ,limited resources ,excessively long RT waiting lists ,Another important argument for HFRT utilization ,even assuming alpha/beta of 1.5GY ,is biologically milder or isoeffective for healthy tissues compered to CFRT .
Cardiac toxicity is potentially long or short term complication of various anticancer therapies systemic therapy as anthracyclines or biological agent implicated in causing irreversible cardiac dysfunction.
Radiotherapy also have cardio toxic effect through different mechanisms
- Conditions
- Breast Cancer Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 45 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
retrospective study of cardiac toxicity in left breast cancer received hypofractionated radiotherapy
detection of toxicity on cardiac ejection fraction in 45 patients received hypofractionated radiotherapy over left breast
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2022
- Study start27 Apr 2022 (estimated)
- Primary completion30 Oct 2023 (estimated)
- Study completion30 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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-control
- Time perspective
- Retrospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Hussien Ahmed Hussien, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05358093
- Sponsor's protocol ID
- left breast cancer
- Status last verified
- Apr 2022
- First submitted
- 30 Mar 2022
- Last updated
- 3 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study of Cardiac Toxicity of Hypo Fractionated Radiotherapy in Left Breast Cancer
- ClinicalTrials.gov ID
- NCT05358093
- Acronym / sponsor ID
- left breast cancer
- Conditions
- Breast Cancer Female
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 27 Apr 2022 (estimated)
- Primary completion
- 30 Oct 2023 (estimated)
- Study completion
- 30 Nov 2023 (estimated)
- First posted
- 3 May 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.
Worldwide, Breast cancer is the most common cancer in women,where 1.7 million new cases diagnosed in 2012 . In 2020 number doubled as 2.3 million women diagnosed with breast cancer. According to ACS 1 in 8 women in United states will develop breast cancer in her life .
Similarly again, In Egypt breast cancer is the most common malignancy in women about 22,700 new cases recorded in 2020. Accounting for 38.8% of cancers in this population and forecasted to be approximately 46,000 in 2050 .
Post-operative radiotherapy is fundamental part of treatment after either conservative surgery or mastectomy . Conventionally fractionated radiation therapy (CFRT) ,Delivering 45-50 GY in 1.8-2 GY daily fractions for 5 days per week over 5-7 weeks was the standard schedule to eradicate sub clinical disease ,sparing normal tissues .After the publication of long term results of randomized controlled trials (RCTs) comparing safety and effectiveness of hypo fractionated RT (HFRT)delivered in3 weeks ,vs. CFRT in node negative BC has been implemented . in 2008 numerous international guidelines recommended HFRT as the new standard being Cost effectiveness ,limited resources ,excessively long RT waiting lists ,Another important argument for HFRT utilization ,even assuming alpha/beta of 1.5GY ,is biologically milder or isoeffective for healthy tissues compered to CFRT .
Cardiac toxicity is potentially long or short term complication of various anticancer therapies systemic therapy as anthracyclines or biological agent implicated in causing irreversible cardiac dysfunction.
Radiotherapy also have cardio toxic effect through different mechanisms
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 45 | – | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- female with left breast cancer
Key inclusion criteria (1 listed)
- 1. Age 18-75 years old 2. histopathology diagnosed 3. Left sided breast cancer 4. Receiving 3D hypofractionated radiotherapy 5. Patients should be non metastatic 6. performance status 0-2
Key exclusion criteria (6 listed)
- • Patient > 75 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
retrospective study of cardiac toxicity in left breast cancer received hypofractionated radiotherapy
Time frame: baseline
detection of toxicity on cardiac ejection fraction in 45 patients received hypofractionated radiotherapy over left breast
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2022.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer Female
Recruiting
Decision Support for Chemoprevention
Breast Cancer
Not yet recruiting
Geriatric Oncology Assessment and Coping Skills Training for Older Women on Aromatase Inhibitor Therapy
Breast Cancer, Hormone Receptor Positive, Aromatase Inhibitor-Associated Arthralgia
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Active, not recruitingPhase 1
A Phase 1 Study of XL309 (ISM3091) Alone and in Combination in Participants With Advanced Solid Tumors
Advanced Solid Tumor
RecruitingPhase 1
A Phase I Study of CG-7321 Monotherapy or Combination Therapy in Advanced Solid Tumors
Advanced Solid Tumors, Breast Cancer
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer Female, run by Assiut University.
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 1 inclusion and 6 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 3 May 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amira Hussien Ahmed, master (01018719085, hussienamira57@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
retrospective study of cardiac toxicity in left breast cancer received hypofractionated radiotherapy (time frame: baseline). 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 3 May 2022.