Letrozole and Metronomic Capecitabine in ER-positive HER2 Negative Advanced Breast Cancer (B-001 Study)
NCT04571437 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 204
Last updated 2020-10-01
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.
Conditions
- Breast Cancer
- Estrogen Receptor-positive Breast Cancer
- Metastatic Breast Cancer
Interventions
- DRUG
-
Capecitabine metronomic combined with Letrozole
- DRUG
-
Letrozole 2.5mg
Letrozole daily alone
Sponsors & Collaborators
-
Cairo University
lead OTHER
Principal Investigators
-
Mariam Saleh, M.D · Cairo University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-03-01
- Primary Completion
- 2021-10-31
- Completion
- 2022-04-30
Countries
- Egypt
Study Locations
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