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

NCT02767661 | Completed Phase 3 DMC

• 1 other identifier: SYSUCC 5010-MECCA
• Study Type: interventional
• Target: 263
• Locations: 1 country
• Sites: 1

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 receptor-positive, Her2-negative advanced breast cancer who have not received prior systemic anti-cancer therapies for their advanced/metastatic disease.

Conditions

Breast Cancer

Keywords

metronomic capecitabine; aromatase inhibitor; first line treatment; metastatic breast cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Overall Survival

  Baseline until death (up to approximately 48 months)

Other Outcomes (5)

• Objective Response Rate (ORR)

  Baseline up to approximately 20 months

• Disease Control Rate (DCR)

  Baseline up to approximately 20 months

• Adverse events

  Baseline up to approximately 20 months

Study Arms (2)

Capecitabine+Aromatase inhibitor

EXPERIMENTAL

Capecitabine, 500mg, orally three times daily in combination with an aromatase inhibitor (Anastrozole 1 mg, orally once daily or Letrozole 2.5mg, orally once daily or Exemestane 25mg, orally once daily)

Drug: Capecitabine; Drug: Aromatase Inhibitor

Aromatase inhibitor

ACTIVE COMPARATOR

Aromatase inhibitor (Anastrozole 1 mg, orally once daily or Letrozole 2.5mg, orally once daily or Exemestane 25mg, orally once daily)

Drug: Aromatase Inhibitor

Interventions

Capecitabine DRUG

Capecitabine, 500mg, orally three times daily (continuously)

Also known as: xeloda

Capecitabine+Aromatase inhibitor

Aromatase Inhibitor DRUG

Aromatase Inhibitor (Anastrozole, 1mg, orally once daily or Letrozole, 2.5mg, orally once daily or Exemestane , 25mg, orally once daily)

Also known as: anastrozole, letrozole, exemestane

Aromatase inhibitor; Capecitabine+Aromatase inhibitor

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Sun Yat-Sen University Cancer Center: collaborator

Study Sites (1)

State Key Laboratory of Oncology in South China, Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

Related Publications (1)

• Hong RX, Xu F, Xia W, Teng YE, Ouyang QC, Zheng QF, Yuan ZY, Chen DS, Jiang KK, Lin Y, Dai Z, Liu XL, Chen QJ, Wu XH, Shi YX, Huang JJ, An X, Xue C, Bi XW, Chen MT, Li H, Yao HR, Zou GR, Huang H, Zhang JM, Wang SS. Metronomic Capecitabine Plus Aromatase Inhibitor as Initial Therapy in Patients With Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Metastatic Breast Cancer: The Phase III MECCA Trial. J Clin Oncol. 2025 Apr 10;43(11):1314-1324. doi: 10.1200/JCO.24.00938. Epub 2025 Jan 2.

  PMID: 39746176 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Capecitabine; Aromatase Inhibitors; Anastrozole; Letrozole; exemestane

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Steroid Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Estrogen Antagonists; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Nitriles; Organic Chemicals; Triazoles; Azoles

Study Officials

• Shusen Wang, MD

  Sun Yat-Sen University Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 7, 2016
• First Posted: May 10, 2016
• Study Start: July 19, 2017
• Primary Completion: August 25, 2023
• Study Completion: August 25, 2023
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

CN (1)