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

Standard Chemotherapy Plus Moxifloxacin as First-line Treatment for Metastatic Triple-negative Breast Cancer : a Multicenter, Double-blind, Placebo-controlled, Phase 3 Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Triple Negative Breast Cancer
• Intervention / Treatment: Drug: Gemcitabine and carboplatin plus antibiotic (moxifloxacin); Drug: Gemcitabine combined with carboplatin plus placebo

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 Type: Interventional
• Enrollment (Anticipated): 228
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Zhong-yu Yuan, M.D.; Phone Number: 862087342794; Email: yuanzhy@sysucc.org.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Recruiting
      • Sun Yat-sen University Cancer Center
      • Contact: Zhong-yu Yuan, MD; Phone Number: 86-20-87343794; Email: yuanzhygz@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
progression-free survival (PFS)	The interval from the date of randomization until the first date on which progression, or death due to any cause	36 months

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Investigators: Study Chair: Zhong-yu Yuan, M.D., Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2021
• Primary Completion (Anticipated): February 1, 2024
• Study Completion (Anticipated): February 1, 2025

Study Registration Dates

• First Submitted: January 21, 2021
• First Submitted That Met QC Criteria: January 22, 2021
• First Posted (Actual): January 25, 2021

Study Record Updates

• Last Update Posted (Actual): November 8, 2022
• Last Update Submitted That Met QC Criteria: November 6, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Triple Negative Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral, Combined; Contraceptives, Oral; Contraceptive Agents, Female; Gemcitabine; Carboplatin; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination; Anti-Bacterial Agents
• Other Study ID Numbers: SYSUCC-003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No