Ignite Creation Date:
2024-05-06 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 12:49 PM
Study NCT ID:
NCT03583463
Status:
COMPLETED
Last Update Posted:
2022-02-07
First Post:
2018-06-27
Brief Title:
ALEXANDRIA Study Egypt
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
A Prospective Non-InterventionaL Study To EXplore the Real-Life MAnagement Of Postmenopausal womeN With Hormone Receptor- Positive Human EpiDermal Growth Factor Receptor 2-Negative Locally Advanced MetastatIc BreAst Cancer In Egypt
Status:
COMPLETED
Status Verified Date:
2022-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Breast Cancer BC is one of the most frequent cancers in women and is the most frequent cause of death in the female population It represents 18 of all female cancers in the world1 The incidence varies in different populations with almost half of the cases having their origin in North America and Western Europe In Egypt according to the National Population-Based Cancer Registry published in 2014 BC was the most frequent cancer among females representing 32 of all female cancers2 Metastatic disease occurs in approximately 20-50 of patients with early BC history and in 6-10 of newly diagnosed BC cases3 Since patients with metastatic BC form a heterogeneous population treatment recommendations ought to be made on an individual basis considering hormone receptor HR and human epidermal growth factor receptor 2 HER2 status metastasis-free interval MFI response to and cumulative doses of previous therapy location and extent of metastases and symptoms 45
Two thirds of BC patients have HR-positive HR tumors 6 for whom endocrine therapy ET is the preferred initial treatment for metastatic disease as recommended in the treatment guidelines even in the presence of visceral metastases 4 6 7 The use of ET is supported by data showing a therapeutic benefit with less toxicity and better quality of life in comparison to chemotherapy CT 589 Nevertheless it is generally thought that CT is associated with greater and earlier tumor response especially in the case of high burden of disease For patients with hormone receptor-positive and HER2 disease CT plus HER2-targeted therapy was strongly recommended except for highly selected cases for whom clinicians may offer ET 10 On the contrary for women with hormone receptor-positive HER2-negative disease who are the scope of this study the question of whether to use CT or ET as first-line treatment for metastatic BC remains to date partially unresolved
Two thirds of BC patients have HR-positive HR tumors 6 for whom endocrine therapy ET is the preferred initial treatment for metastatic disease as recommended in the treatment guidelines even in the presence of visceral metastases 4 6 7 The use of ET is supported by data showing a therapeutic benefit with less toxicity and better quality of life in comparison to chemotherapy CT 589 Nevertheless it is generally thought that CT is associated with greater and earlier tumor response especially in the case of high burden of disease For patients with hormone receptor-positive and HER2 disease CT plus HER2-targeted therapy was strongly recommended except for highly selected cases for whom clinicians may offer ET 10 On the contrary for women with hormone receptor-positive HER2-negative disease who are the scope of this study the question of whether to use CT or ET as first-line treatment for metastatic BC remains to date partially unresolved
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None