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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 world.1 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 cases.3 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 4,5.
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) 5,8,9. 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.
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with ER positive, HER2 negative locally advanced or metastatic breast cancer assigned to each treatment modality used as the first line of treatment. | Proportion of patients with ER positive, HER2 negative locally advanced or metastatic breast cancer assigned to each treatment modality used as the first line of treatment. | 18 Months |
| Characteristics of patients in each treatment modality according to their histologic diagnosis, Hormone sensitivity, visceral vs non-visceral disease proportion, reason for selecting the treatment. | Characteristics of patients in each treatment modality according to their histologic diagnosis, Hormone sensitivity, visceral vs non-visceral disease proportion, reason for selecting the treatment. | 18 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival of patients receiving first line treatment for ER positive, HER2 negative locally advanced or metastatic breast cancer, for all patients. | Progression-free survival of patients receiving first line treatment for ER positive, HER2 negative locally advanced or metastatic breast cancer, for all patients. | 18 Months |
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Inclusion Criteria:
Exclusion Criteria:
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Postmenopausal women with ER positive, HER-2 negative locally advanced/ metastatic breast cancer, who either progressed during or after adjuvant endocrine therapy for early breast cancer or those presenting with de novo metastatic disease who had not received prior endocrine therapy. Patients should have already been prescribed first line treatment for their locally advanced/ metastatic breast cancer as per routine clinical practice prior to their enrolment in the study. Their participation in the study should in no way impact the treatment and care that they receive.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Alexandria | Egypt | ||||
| Research Site |
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| Label | URL |
|---|---|
| Redacted CSR synopsis | View source |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Response Rate (RR) of patients receiving first line treatment for ER positive, HER2 negative locally advanced or metastatic breast cancer. |
Response Rate (RR) of patients receiving first line treatment for ER positive, HER2 negative locally advanced or metastatic breast cancer. |
| 18 Months |
| Proportions of patients on each second line treatment modality in patients diagnosed with ER positive, HER2 negative locally advanced or metastatic breast cancer. | Proportions of patients on each second line treatment modality (subsequent therapy following progression on first line treatment described in primary outcome variable) in patients diagnosed with ER positive, HER2 negative locally advanced or metastatic breast cancer. | 18 Months |
| Cairo |
| Egypt |
| Research Site | El Gharbia | Egypt |
| Research Site | El Menofia | Egypt |
| Research Site | Gharbia | Egypt |
| Research Site | Giza | Egypt |
| Research Site | Luxur | Egypt |
| Research Site | Zagazig | Egypt |
| D017437 |
| Skin and Connective Tissue Diseases |