ALEXANDRIA Study Egypt

NCT03583463 | Completed

• 1 other identifier: D133FR00138
• Study Type: observational
• Target: 436
• Locations: 1 country
• Sites: 8

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 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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (3)

• 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

• 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.

  18 Months

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Provision of written informed consent prior to any study specific procedures
• Post-menopausal women (Defined as a woman who have experienced at least 12 consecutive months without menstruation, who had undergone bilateral ovariectomy or who has menopausal levels of serum Estradiol and FSH.)
• Hormone receptor positive, HER2 negative locally advanced or metastatic breast cancer.
• Patients with either de novo metastatic disease who had not received any prior treatment or those who progressed during or after previous adjuvant endocrine treatment for early breast cancer.
• Hormone sensitive patients (per the ABC2 guidelines published in Annals of Oncology 00: 1-18, 2014, defined as relapse while on adjuvant ET but after the first 2 years, or a relapse after/within 12 months of completing adjuvant ET. Patients with ER+ de novo metastatic disease are also considered hormone sensitive patients)
• Patients have already been prescribed treatment with ET either as monotherapy or in combination or physician's choice of a standard of care chemotherapy within the previous 90 days prior to their enrolment.

You may not qualify if:

• Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
• Current enrollment and/or participation in another clinical study during the last 90 days.
• Presence of visceral crisis.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (8)

Research Site

Alexandria, Egypt

Location

Research Site

Cairo, Egypt

Location

Research Site

El Gharbia, Egypt

Location

Research Site

El Menofia, Egypt

Location

Research Site

Gharbia, Egypt

Location

Research Site

Giza, Egypt

Location

Research Site

Luxur, Egypt

Location

Research Site

Zagazig, Egypt

Location

Related Links

• Redacted CSR synopsis

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 18 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2018
• First Posted: July 11, 2018
• Study Start: October 29, 2018
• Primary Completion: January 24, 2021
• Study Completion: January 24, 2021
• Last Updated: February 7, 2022

Record last verified: 2022-01

Locations

EG (8)