Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05988112 |
| Other study ID # |
Amira Ali |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 1, 2024 |
| Est. completion date |
September 1, 2025 |
Study information
| Verified date |
March 2024 |
| Source |
Assiut University |
| Contact |
Amira Ali Fekry, master |
| Phone |
01099824589 |
| Email |
aliamera825[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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
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 .
