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NCT04722978 | RECRUITING | Triple Negative Breast Cancer

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

Sun Yat-Sen University Cancer Center

Information provided by (Responsible Party):

zhong-yuan

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

Triple Negative Breast Cancer

Intervention/treatment

Gemcitabine and carboplatin plus antibiotic (moxifloxacin)

Gemcitabine combined with carboplatin plus placebo

Phase

PHASE3

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
Estimated Enrollment : 228 participants
Masking : QUADRUPLE
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 : 2021-04-20
Estimated Primary Completion Date : 2026-06
Estimated Study Completion Date : 2026-07

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 70 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
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.
Standard Chemotherapy Plus Moxifloxacin as First-line Treatment for Metastatic Triple-negative Breast Cancer

Location Details

NCT04722978

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Locations

RECRUITING

China, Guangdong

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China, 510060