Status:
ACTIVE_NOT_RECRUITING
Metronomic Capecitabine Plus Aromatase Inhibitor for First Line Treatment in HR(+), Her2(-) Metastatic Breast Cancer
Lead Sponsor:
Sun Yat-sen University
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-70 years
Phase:
PHASE3
Brief 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 re...
Detailed Description
Initial endocrine therapy (ET) is a common choice for hormone receptor positive (HR+), HER2 negative (HER2-) metastatic breast cancer (MBC) patients for its good tolerability, low toxicity and durable...
Eligibility Criteria
Inclusion
- 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 locoregionally recurrent or metastatic disease
- Any menopausal status, but premenopausal or perimenopausal patients are required to receive LHRHa treatment
- Measurable disease defined by RECIST version 1.1, or bone-only disease
- Eastern Cooperative Oncology Group (ECOG) 0-2, and life expectancy ≥ 3 months
- Adequate organ and marrow function
- Resolution of all toxic effects of prior therapy or surgical procedures
Exclusion
- Patients who have progressed within 2 years of adjuvant endocrine therapy
- Patients who have not received prior endocrine therapy and are eligible to receive fulvestrant as initial therapy
- 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
- Diagnosis of any other malignancy within 3 years prior to randomization (except adequately treated basal or squamous cell skin cancer or cervical carcinoma in situ)
- Serious uncontrolled intercurrent infections or intercurrent medical or psychiatric illness
Key Trial Info
Start Date :
July 19 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2024
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT02767661
Start Date
July 19 2017
End Date
May 1 2024
Last Update
February 16 2024
Active Locations (1)
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1
State Key Laboratory of Oncology in South China, Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060