Locoregional RecurrenceNCT05988112
Locoregional Recurrence of Breast Cancer
An observational study of Locoregional Recurrence, run by Assiut University.
Trial summary
our study will be retrospective on breast cancer patients to detect relation between the locoregional recurrence of breast cancer after radiotherapy and the molecular subtypes Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locoregional Recurrence
- How many people
- 265 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2024to 1 Sep 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 18 years and older
- All sexes
- Adult, Older adult
Study population: patients diagnosed with breast cancer in clinical oncology department , Assuit university hospital
Who may be able to join
- Age ≥ 18
- Male or female
- Histological proven breast cancer (IDC / ILC)
- with known receptor status
- Patient did mastectomy or breast conservative surgery +/- lymph node dissection .
- received radiotherapy
- on regular follow up
Who cannot join
- Metastatic from the start (stage 4)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Locoregional Recurrence After Radiotherapy in Breast Cancer Patients Based on Molecular Subtypes
our study will be retrospective on breast cancer patients to detect relation between the locoregional recurrence of breast cancer after radiotherapy and the molecular subtypes
Read the detailed description
Having replaced lung cancer as the most common cancer globally, breast cancer today represent 1 in 8 cancer cases and a total of 2.3 million new cases in both sexes .
It Represents a quarter of all cancer cases in females, and it was the most commonly diagnosed cancer in women in 2020 , its burden has been growing in many parts of the world, particularly in transitioning countries . An estimated 685,000 women died from breast cancer in 2020, corresponding to 16% or 1 in every 6 cancer deaths in women.
In Egypt, it constitutes 33% of female cancer cases and more than 22,000 new cases diagnosed each year .
Treatment Strategies include Surgery, Chemotherapy ,Radiotherapy, Endocrinal (Hormonal) Therapy \& Biological Therapy , according to stages and molecular subtypes
A majority of breast cancer patients undergoing surgical excision will receive radiotherapy as a local treatment, which will reduce local and regional recurrence (LRR), further elevating survival.
Slightly over 50% of women with early-stage breast cancer remain disease free for at least 10 years, but recurrences continue to occur long after primary diagnosis.
Several multigene molecular assays are currently under investigation to accurately identify patients with unfavorable prognosis .However, considering the lack of cost-effectiveness of these detection approaches, they are not easily applied on a large scale, especially in less developed countries. In contrast, immunohistochemical (IHC) staining profile is a cost-effective and popular surrogate.Based on IHC staining profiles, St Gallen International Breast Cancer Conference in 2013 classified breast cancer into four subtypes: Luminal A, Luminal B, HER2-positive, and triple-negative breast cancer (TNBC). This classification system has been widely used in clinical decision-making for the systemic management of breast cancer.
This classification depend on presence or absence of estrogen receptor (ER), progesterone receptor (PR), human epidermal growth factor (Her2) and Ki 67 as luminal A is positive for ER \&PR, negative for Her2 with low Ki67, luminal B is ER positive, PR \& Her2 may be positive or negative but with high Ki67, Her2 is ER \&PR negative with Her2 positive, Triple negative (TN) is ER \& PR \& Her2 negative with high Ki67, with no benefit of hormonal or anti Her2 therapy.
Few studies done showed that Luminal A and B subtypes are generally associated with lower risks of regional nodal involvement at diagnosis and tend to have a more indolent evolution as compared with the other subtypes. Several retrospective studies have shown lower rates of LRR in luminal A as compared with the other subtypes, among whom luminal B is considered as intermediate risk with rates ranging between 1.5 and 8.7% and peak incidence during the first 5 years .
For HER2-positive patients, there are two distinct periods. In studies in which patients were not treated with HER2-targeted therapy, LRR rates ranged between 4 and 15% .
More recently, trastuzumab have positively modified the natural course of this BC subtype. patients with HER2-positive tumors who underwent surgery and received trastuzumab had LRR rate of 1.7%. This finding was supported by many studies, who also showed that trastuzumab treatment resulted in a decrease in LRR by 50%. This has also been observed in small tumors HER2-positive BC study after trastuzumab .
The TNG subtype was associated with increased LRR rates, after breast conservation and mastectomy (3-17%). Moreover, after the diagnosis of an LRR, the TNG subtype is associated with a high incidence of distant metastases .
- Conditions
- Locoregional Recurrence
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine Local & regional recurrence according to different molecular subtypes.
radiologically or with re biopsy
Measured: within 5 years from diagnosis
- 5-year free survival
radiologically
Measured: within 5 years from diagnosis
Secondary outcomes (1)
Metastasis-Free Survival
radiologically
Measured: within 5 years from diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start1 Aug 2024 (estimated)
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locoregional RecurrenceStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 265 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Ali Fekry Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05988112
- Sponsor's protocol ID
- Amira Ali
- Status last verified
- Jul 2024
- First submitted
- 4 Aug 2023
- Last updated
- 16 Jul 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Locoregional Recurrence After Radiotherapy in Breast Cancer Patients Based on Molecular Subtypes
- ClinicalTrials.gov ID
- NCT05988112
- Acronym / sponsor ID
- Amira Ali
- Conditions
- Locoregional Recurrence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 265 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 14 Aug 2023 (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.
our study will be retrospective on breast cancer patients to detect relation between the locoregional recurrence of breast cancer after radiotherapy and the molecular subtypes
Detailed description
Having replaced lung cancer as the most common cancer globally, breast cancer today represent 1 in 8 cancer cases and a total of 2.3 million new cases in both sexes .
It Represents a quarter of all cancer cases in females, and it was the most commonly diagnosed cancer in women in 2020 , its burden has been growing in many parts of the world, particularly in transitioning countries . An estimated 685,000 women died from breast cancer in 2020, corresponding to 16% or 1 in every 6 cancer deaths in women.
In Egypt, it constitutes 33% of female cancer cases and more than 22,000 new cases diagnosed each year .
Treatment Strategies include Surgery, Chemotherapy ,Radiotherapy, Endocrinal (Hormonal) Therapy \& Biological Therapy , according to stages and molecular subtypes
A majority of breast cancer patients undergoing surgical excision will receive radiotherapy as a local treatment, which will reduce local and regional recurrence (LRR), further elevating survival.
Slightly over 50% of women with early-stage breast cancer remain disease free for at least 10 years, but recurrences continue to occur long after primary diagnosis.
Several multigene molecular assays are currently under investigation to accurately identify patients with unfavorable prognosis .However, considering the lack of cost-effectiveness of these detection approaches, they are not easily applied on a large scale, especially in less developed countries. In contrast, immunohistochemical (IHC) staining profile is a cost-effective and popular surrogate.Based on IHC staining profiles, St Gallen International Breast Cancer Conference in 2013 classified breast cancer into four subtypes: Luminal A, Luminal B, HER2-positive, and triple-negative breast cancer (TNBC). This classification system has been widely used in clinical decision-making for the systemic management of breast cancer.
This classification depend on presence or absence of estrogen receptor (ER), progesterone receptor (PR), human epidermal growth factor (Her2) and Ki 67 as luminal A is positive for ER \&PR, negative for Her2 with low Ki67, luminal B is ER positive, PR \& Her2 may be positive or negative but with high Ki67, Her2 is ER \&PR negative with Her2 positive, Triple negative (TN) is ER \& PR \& Her2 negative with high Ki67, with no benefit of hormonal or anti Her2 therapy.
Few studies done showed that Luminal A and B subtypes are generally associated with lower risks of regional nodal involvement at diagnosis and tend to have a more indolent evolution as compared with the other subtypes. Several retrospective studies have shown lower rates of LRR in luminal A as compared with the other subtypes, among whom luminal B is considered as intermediate risk with rates ranging between 1.5 and 8.7% and peak incidence during the first 5 years .
For HER2-positive patients, there are two distinct periods. In studies in which patients were not treated with HER2-targeted therapy, LRR rates ranged between 4 and 15% .
More recently, trastuzumab have positively modified the natural course of this BC subtype. patients with HER2-positive tumors who underwent surgery and received trastuzumab had LRR rate of 1.7%. This finding was supported by many studies, who also showed that trastuzumab treatment resulted in a decrease in LRR by 50%. This has also been observed in small tumors HER2-positive BC study after trastuzumab .
The TNG subtype was associated with increased LRR rates, after breast conservation and mastectomy (3-17%). Moreover, after the diagnosis of an LRR, the TNG subtype is associated with a high incidence of distant metastases .
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients diagnosed with breast cancer in clinical oncology department , Assuit university hospital
Key inclusion criteria (7 listed)
- Age ≥ 18
- Male or female
- Histological proven breast cancer (IDC / ILC)
- with known receptor status
- Patient did mastectomy or breast conservative surgery +/- lymph node dissection .
Key exclusion criteria (1 listed)
- Metastatic from the start (stage 4)
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
Determine Local & regional recurrence according to different molecular subtypes.
Time frame: within 5 years from diagnosis
radiologically or with re biopsy
- 5-year free survival
Time frame: within 5 years from diagnosis
radiologically
1 secondary outcome
Metastasis-Free Survival
Time frame: within 5 years from diagnosis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Locoregional Recurrence, 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 7 inclusion and 1 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 16 Jul 2024. 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 Ali Fekry, master (01099824589, aliamera825@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine Local & regional recurrence according to different molecular subtypes. (time frame: within 5 years from diagnosis). 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 16 Jul 2024.