NCT04571437

Letrozole and Metronomic Capecitabine in ER-positive HER2 Negative Advanced Breast Cancer (B-001 Study)

Letrozole With or Without Metronomic Capecitabine in First Line Treatment of Patients With ER-positive HER2 Negative Advanced Breast Cancer: A Randomized Phase II Study.

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 204 (estimated)
• Sponsor: Cairo University · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

A phase II clinical trial designed to test the effect of combining endocrinal therapy (Letrozole) with chemotherapy (Capecitabine) in first line treatment of advanced cases of female breast cancer with ER positive disease.

Detailed description

This is a randomized clinical trial that assigns patients with female breast cancer in the metastatic entity or advanced -beyond local disease treatment - entity into two arms. Arm A contains Letrozole with metronomic Capecitabine versus arm B that contains Letrozole alone. This is to be applied on ER positive HER2 negative tumours.

Conditions

• Breast Cancer
• Estrogen Receptor-positive Breast Cancer
• Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	Capecitabine	Capecitabine metronomic combined with Letrozole
DRUG	Letrozole 2.5mg	Letrozole daily alone

Timeline

• Start date: 2020-03-01
• Primary completion: 2021-10-31
• Completion: 2022-04-30
• First posted: 2020-10-01
• Last updated: 2020-10-01

Locations

1 site across 1 country: Egypt