Breast Cancer Clinical Trial
— MECCAOfficial title:
A Phase 3 Randomized Controlled Study of Metronomic Capecitabine Combined With Aromatase Inhibitor Versus Aromatase Inhibitor Alone for First Line Treatment in Hormone Receptor-positive, Her2-negative Metastatic Breast Cancer
Verified date | February 2024 |
Source | Sun Yat-sen University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 240 |
Est. completion date | May 2024 |
Est. primary completion date | May 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 70 Years |
Eligibility | 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 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 Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
China | State Key Laboratory of Oncology in South China, Sun Yat-sen University Cancer Center | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Sun Yat-sen University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Objective Response Rate (ORR) | Objective response is defined as a complete response (CR) or partial response (PR) according to RECIST v.1.1. recorded from randomization until disease progression or death due to any cause. | Baseline up to approximately 20 months | |
Other | Disease Control Rate (DCR) | Disease control is defined as complete response (CR), partial response (PR), or stable disease (SD) >24 weeks according to the RECIST version 1.1 recorded in the time period between randomization and disease progression or death to any cause. | Baseline up to approximately 20 months | |
Other | Adverse events | Adverse events, serious adverse events, and laboratory tests will be analyzed and summarized according to severity. | Baseline up to approximately 20 months | |
Other | Quality-of-life score | The Functional Assessment of Cancer Therapy - Breast (FACT-B) version 4 questionnaire will be distributed to the patients by the study site personnel and will be filled out by the patients independently. Final scores (FACT-B-Total) of all subscales range from 0 to 148, where 148 represents the most favorable score and accordingly a highest QoL. | Baseline up to approximately 20 months | |
Other | Quality-of-life score | EORTC QLQ-BR23 questionnaire will be distributed to the patients by the study site personnel and will be filled out by the patients independently. | Baseline up to approximately 20 months | |
Primary | Progress-free survival | Time from randomization to the first documentation of objective tumor progression or to death due to any cause without documented progression. | Baseline up to approximately 20 months | |
Secondary | Overall Survival | Time from randomization to date of death due to any cause. | Baseline until death (up to approximately 48 months) |
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