Letrozole Plus Metronomic Capecitabine as First-line Treatment for Patients With Recurrent or Metastatic Breast Cancer

• Status: Not yet recruiting
• Trial end date: 2025-05-31
• Target enrollment: 0
• Participant gender: Female

Summary

The study is designed to assess the treatment outcomes following treatment with letrozole plus metronomic capecitabine in patients with hormone receptor-positive, Her2-negative advanced breast cancer who have not received prior systemic anti-cancer therapies for their recurrent /metastatic disease.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assiut University
• Treatments: Capecitabine; Letrozole

Criteria

Inclusion Criteria:

• Confirmed diagnosis of hormonal receptor-positive (HR+)/Her2-negative breast cancer

• No prior systemic anti-cancer therapy for advanced HR+ disease except tamoxifen treatment in adjuvant sitting

• If the patient is pre-/peri- menopausal, a luteinizing hormone-releasing hormone (LHRH) agonist will be given for at least 28 days before randomization or ovarian ablation or suppression by surgery or radiotherapy

• Measurable disease defined by RECIST version 1.1,

• Eastern Cooperative Oncology Group (ECOG) 0-1

• Adequate organ and marrow function.

Exclusion Criteria:

• Patients with advanced, symptomatic visceral spread (visceral crisis)

• Patients diagnosed with central nervous system metastases

• Second primary malignancy