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

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ClinicalTrials.gov Identifier: NCT02767661
Recruitment Status : Recruiting
First Posted : May 10, 2016
Last Update Posted : November 29, 2017
Sponsor:
Information provided by (Responsible Party):
wang shusen, Sun Yat-sen University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Capecitabine Drug: Aromatase Inhibitor Phase 3

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 response. The median time to progression (TTP) of initial ET in HR+, HER2- metastatic patients is about 9 months with aromatase inhibitors (AIs). However, all metastatic patients receiving ET will develop resistance to the conventional endocrine treatments ultimately. So some novel agents, like palbociclib and everolimus, are approved to be effective in improving the efficacy of standard ET. But the fact we have to face is either palbociclib or everolimus is focusing on a single checkpoint of pathway that responsible for resistance of ET. In clinical, there are some patients without an activation of resistance-related pathways have poor response to endocrine therapy. And the mechanisms of resistance to endocrine therapy is complicated and not fully understood. So far, these novel agents have not completely solved the clinical problems of secondary drug-resistance. Maybe a broad spectrum anti-cancer therapy with low toxicity and good tolerability is more practical and promising in the near future. Metronomic chemotherapy is administration of low-dose chemotherapy to induce disease control in metastatic cancer patients, which has low-incidence of adverse effects. More and more evidences showed activity of metronomic therapy in breast cancer. Metronomic therapy with or without endocrine therapy in both metastatic and neoadjuvant setting showed considerable efficacy. Although the concept of combination of chemotherapy and endocrine therapy simultaneously was large abandoned because of previous using tamoxifen and intravenous chemotherapy showing no additional benefit, with better understanding of the biology of endocrine therapy and metronomic chemotherapy, it's worth to evaluate whether endocrine therapy plus low-dose metronomic chemotherapy brings a better clinical benefit rate without sacrificing the quality of patients' life. In this phase III study, we investigate the efficacy and safety of low-dose capecitabine plus AI to treat metastatic HR+, HER2- postmenopausal breast cancer patients.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : July 19, 2017
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: Capecitabine+Aromatase inhibitor
Capecitabine, 625mg/m2, orally twice 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
Capecitabine, 625mg/m2, orally twice daily (continuously)
Other Name: xeloda

Drug: Aromatase Inhibitor
Aromatase Inhibitor (Anastrozole, 1mg, orally once daily or Letrozole, 2.5mg, orally once daily or Exemestane , 25mg, orally once daily)
Other Names:
  • anastrozole
  • letrozole
  • exemestane
Active Comparator: Aromatase inhibitor
Aromatase inhibitor (Anastrozole 1 mg, orally once daily or Letrozole 2.5mg, orally once daily or Exemestane 25mg, orally once daily)
 Drug: Aromatase Inhibitor
Aromatase Inhibitor (Anastrozole, 1mg, orally once daily or Letrozole, 2.5mg, orally once daily or Exemestane , 25mg, orally once daily)
Other Names:
  • anastrozole
  • letrozole
  • exemestane


Outcome Measures
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Primary Outcome Measures :
  1. Progress-free survival [ Time Frame: Baseline up to approximately 20 months ]
    Time from randomization to the first documentation of objective tumor progression or to death due to any cause.


Secondary Outcome Measures :
  1. Overall Survival [ Time Frame: Baseline until death (up to approximately 48 months) ]
    Time from randomization to date of death due to any cause.


Other Outcome Measures:
  1. Objective Response Rate (ORR) [ Time Frame: Baseline up to approximately 20 months ]
    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.

  2. Disease Control Rate (DCR) [ Time Frame: Baseline up to approximately 20 months ]
    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.

  3. Change From Baseline in Euro Quality of Life (EQ-5D)- Health State Profile Utility [ Time Frame: Baseline up to approximately 20 months ]
    Instrument designed to assess health status in terms of a single index value or utility score.

  4. Change From Baseline in Functional Assessment od Cancer therapy -Breast (FACT-B) [ Time Frame: Baseline up to approximately 20 months ]
    Instrument designed to assess patient concerns relating to breast cancer


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02767661


Contacts
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Contact: Shusen Wang, MD +86-13926168469 wangshs@sysucc.org.cn

Locations
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China, Guangdong
State Key Laboratory of Oncology in South China, Sun Yat-sen University Cancer Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: fei xu, M.D.    862087342693    xufei@sysucc.org.cn   
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Principal Investigator: Shusen Wang, MD Sun Yat-sen University
More Information
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Responsible Party: wang shusen, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02767661    
Other Study ID Numbers: SYSUCC 5010-MECCA
First Posted: May 10, 2016    Key Record Dates
Last Update Posted: November 29, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by wang shusen, Sun Yat-sen University:
metronomic capecitabine
aromatase inhibitor
first line treatment
metastatic breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Capecitabine
Letrozole
Anastrozole
Exemestane
Aromatase Inhibitors
Antimetabolites, Antineoplastic
 Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal