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Standard Chemotherapy Plus Moxifloxacin as First-line Treatment for Metastatic Triple-negative Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04722978
Recruitment Status : Recruiting
First Posted : January 25, 2021
Last Update Posted : November 4, 2021
Sponsor:
Information provided by (Responsible Party):
Zhong-yu Yuan, Sun Yat-sen University

Study Description
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Brief Summary:
The primary objective of this study is to compare progression-free survival (PFS) of patients with metastatic triple-negative breast cancer randomised to treatment with standard chemotherapy plus moxifloxacin or placebo.

Condition or disease Intervention/treatment Phase
Triple Negative Breast Cancer Drug: Gemcitabine and carboplatin plus antibiotic (moxifloxacin) Drug: Gemcitabine combined with carboplatin plus placebo Phase 3

Detailed Description:
This is a multicenter, randomised, double-blind, placebo-controlled, phase 3 trial. The main purposes of this study are to examine the efficacy and safety of standard chemotherapy plus moxifloxacin or placebo as first-line treatment in patients with metastatic triple-negative breast cancer. This study is designed to recruit up to 228 subjects.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 228 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Gemcitabine combined with carboplatin plus moxifloxacin or placebo
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Standard Chemotherapy Plus Moxifloxacin as First-line Treatment for Metastatic Triple-negative Breast Cancer : a Multicenter, Double-blind, Placebo-controlled, Phase 3 Trial
Actual Study Start Date : April 20, 2021
Estimated Primary Completion Date : February 2024
Estimated Study Completion Date : February 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Experimental group
Gemcitabine combined with carboplatin plus moxifloxacin
 Drug: Gemcitabine and carboplatin plus antibiotic (moxifloxacin)
Standard chemotherapy (gemcitabine and carboplatin) plus antibiotic (moxifloxacin)
Other Name: Gemcitabine 1000mg/m^2 IV on days 1 and 8; cycled every 21 days Carboplatin AUC 2 IV on days 1 and 8; cycled every 21 days Moxifloxacin 0.4 PO once daily days 1-5; cycled every 21 days
Placebo Comparator: Control group
Gemcitabine combined with carboplatin plus placebo
 Drug: Gemcitabine combined with carboplatin plus placebo
Standard chemotherapy (gemcitabine and carboplatin) plus placebo
Other Name: Gemcitabine 1000mg/m^2 IV on days 1 and 8; cycled every 21 days Carboplatin AUC 2 IV on days 1 and 8; cycled every 21 days Placebo 0.4 PO once daily days 1-5; cycled every 21 days


Outcome Measures
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Primary Outcome Measures :
  1. progression-free survival (PFS) [ Time Frame: 36 months ]
    The interval from the date of randomization until the first date on which progression, or death due to any cause


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:

  • Eastern Cooperative Oncology Group (ECOG) score of 0 to 1.
  • Histologically confirmed invasive ductal carcinoma, no specific type (NOS)
  • ER negative and progesterone receptor (PR) negative (defined as < 1% positive cells by IHC), human epidermal growth factor receptor 2 (HER2) negative (defined as IHC 0-1 staining or fluorescent in situ hybridization (FISH) negative).
  • No prior therapy after first recurrence or diagnosis of metastatic disease.
  • At least 1 measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
  • Neutrophil-to-lymphocyte ratios (NLR) in peripheral blood ≥ 2.
  • Adequate organ function including bone marrow, renal function, hepatic function, and cardiac reserve (Left ventricular ejection fraction (LVEF) by echocardiogram ≥45%).
  • Compliance with the study protocol.
  • Have provided written and signed informed consent.

Exclusion Criteria:

  • Pregnant or breast feeding.
  • Definitive breast cancer susceptibility gene (BRCA) mutation, Programmed Cell Death-Ligand 1 (PD-L1) positive, microsatellite instability-high (MSI-H), and mismatch repair deficient (dMMR).
  • Patients who are receiving or will receive other biological agents or immunotherapy.
  • Uncontrolled medical problems.
  • Evidence of active acute or chronic infection.
  • Hepatic, renal, cardiac, or bone marrow dysfunction as detailed above.
  • Concurrent malignancy or history of other malignancy within the last five years.
  • Known severe hypersensitivity to moxifloxacin
  • Patients were unable or unwilling to comply with program requirements.
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): NCT04722978


Contacts
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Contact: Zhong-yu Yuan, M.D. 862087342794 yuanzhy@sysucc.org.cn

Locations
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China, Guangdong
Sun Yat-sen University Cancer Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Zhong-yu Yuan, MD    86-20-87343794    yuanzhygz@163.com   
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Study Chair: Zhong-yu Yuan, M.D. Sun Yat-sen University
More Information
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Responsible Party: Zhong-yu Yuan, Clinical Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT04722978    
Other Study ID Numbers: SYSUCC-003
First Posted: January 25, 2021    Key Record Dates
Last Update Posted: November 4, 2021
Last Verified: November 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Gemcitabine
Moxifloxacin
Anti-Bacterial Agents
Carboplatin
Norgestimate, ethinyl estradiol drug combination
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
 Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Contraceptive Agents, Hormonal
Contraceptive Agents
Reproductive Control Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female