Metronomic Capecitabine Plus Aromatase Inhibitor for First Line Treatment in HR(+), Her2(-) Metastatic Breast Cancer

• Status: Recruiting
• Trial end date: 2023-05-01
• Target enrollment: 0
• Participant gender: Female

Summary

The study is designed to compare the clinical benefit following treatment with aromatase inhibitor in combination with metronomic capecitabine versus aromatase inhibitor alone in women with hormone receptor-positive, Her2-negative advanced breast cancer who have not received prior systemic anti-cancer therapies for their advanced/metastatic disease.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Treatments: Anastrozole; Aromatase Inhibitors; Capecitabine; Exemestane; Letrozole

Criteria

Inclusion Criteria:

• Adult women with locoregionally recurrent or metastatic disease not amenable to curative therapy

• Confirmed diagnosis of ER positive/Her2-negative breast cancer

• No prior systemic anti-cancer therapy for advanced ER+ disease

• Any menopausal status

• On a luteinizing hormone releasing hormone (LHRH) agonist for at least 28 days, if pre-/peri-menopausal, and willing to switch to goserelin (Zoladex ®) at time of randomization

• Measurable disease defined by RECIST version 1.1, or bone-only disease

• Eastern Cooperative Oncology Group (ECOG) 0-1

• Adequate organ and marrow function

• Resolution of all toxic effects of prior therapy or surgical procedures

• Patient must agree to provide tumor tissue from metastatic tissue at baseline

Exclusion Criteria:

• Patients with advanced, symptomatic, visceral spread that are at risk of life threatening complication in the short term

• Known uncontrolled or symptomatic central nervous system metastases

• Second primary malignancy(except in situ carcinoma of the cervix or adequately treated nonmelanomatous carcinoma of the skin)

• Serious uncontrolled intercurrent infections or intercurrent medical or psychiatric illness