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

Primary Purpose

Triple Negative Breast Cancer

Status

Recruiting

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Gemcitabine and carboplatin plus antibiotic (moxifloxacin)

Gemcitabine combined with carboplatin plus placebo

About this trial

This is an interventional treatment trial for Triple Negative Breast Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Sun Yat-sen University Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Experimental group

Control group

Arm Description

Gemcitabine combined with carboplatin plus moxifloxacin

Gemcitabine combined with carboplatin plus placebo

Outcomes

Primary Outcome Measures

progression-free survival (PFS)

The interval from the date of randomization until the first date on which progression, or death due to any cause

Secondary Outcome Measures

Full Information

NCT ID

NCT04722978

First Posted

January 21, 2021

Last Updated

November 6, 2022

Sponsor

Sun Yat-sen University

1. Study Identification

Unique Protocol Identification Number

NCT04722978

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Recruiting

Study Start Date

April 20, 2021 (Actual)

Primary Completion Date

February 2024 (Anticipated)

Study Completion Date

February 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Triple Negative Breast Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

Gemcitabine combined with carboplatin plus moxifloxacin or placebo

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

228 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Experimental group

Arm Type

Active Comparator

Arm Description

Gemcitabine combined with carboplatin plus moxifloxacin

Arm Title

Control group

Arm Type

Placebo Comparator

Arm Description

Gemcitabine combined with carboplatin plus placebo

Intervention Type

Drug

Intervention Name(s)

Gemcitabine and carboplatin plus antibiotic (moxifloxacin)

Other Intervention Name(s)

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

Intervention Description

Standard chemotherapy (gemcitabine and carboplatin) plus antibiotic (moxifloxacin)

Intervention Type

Drug

Intervention Name(s)

Gemcitabine combined with carboplatin plus placebo

Other Intervention Name(s)

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

Intervention Description

Standard chemotherapy (gemcitabine and carboplatin) plus placebo

Primary Outcome Measure Information:

Title

progression-free survival (PFS)

Description

The interval from the date of randomization until the first date on which progression, or death due to any cause

Time Frame

36 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Zhong-yu Yuan, M.D.

Phone

862087342794

yuanzhy@sysucc.org.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zhong-yu Yuan, M.D.

Organizational Affiliation

Sun Yat-sen University

Official's Role

Study Chair

Facility Information:

Facility Name

Sun Yat-sen University Cancer Center

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510060

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Zhong-yu Yuan, MD

Phone

86-20-87343794

yuanzhygz@163.com

12. IPD Sharing Statement

Learn more about this trial

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

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