Moxifloxacin in Adjuvant Treatment of Patients With Operable Breast Cancer

NCT ID: NCT05114720

Last Updated: 2025-12-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 559 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-11
• Study Completion Date: 2025-11-27

Brief Summary

The primary objective of this study is to compare disease-free survival (DFS) of patients with operable breast cancer randomised to treatment with standard adjuvant chemotherapy plus moxifloxacin or placebo.

Detailed Description

This is a multicenter, randomised, double-blind, placebo-controlled, phase 3 clinical trial. The main purposes of this study are to examine the efficacy and safety of standard adjuvant chemotherapy plus moxifloxacin or placebo as care for patients with operable breast cancer. This study is designed to recruit up to 520 subjects.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

standard adjuvant chemotherapy plus moxifloxacin

Standard adjuvant chemotherapy (Taxanes combined with cyclophosphamide or doxorubicin combined with cyclophosphamide followed by taxanes) plus antibiotic (moxifloxacin)

Other Name: docetaxel 75mg/m^2, or nab-paclitaxel 260mg/m^2, IV, days 1, cycled every 21 days cyclophosphamide 1000 mg/m^2, IV, days 1, cycled every 21 days; or doxorubicin 60mg/m^2, IV, days 1, combined with cyclophosphamide 600 mg/m^2, IV, days 1, followed by docetaxel 75mg/m^2, or nab-paclitaxel 260mg/m^2, IV, days 1; plus Moxifloxacin 0.4 PO once daily days 1-5; cycled every 21 days

Group Type: EXPERIMENTAL

standard adjuvant chemotherapy plus moxifloxacin

Intervention Type: DRUG

docetaxel 75mg/m\^2, or nab-paclitaxel 260mg/m\^2, IV, days 1 cyclophosphamide 1000 mg/m\^2, IV, days 1, cycled every 21 days; or doxorubicin 60mg/m\^2, IV, days 1, cycled every 21 days cyclophosphamide 600 mg/m\^2, IV, days 1, cycled every 21 days docetaxel 100 mg/m\^2, IV, days 1, cycled every 21 days; plus Moxifloxacin 0.4 PO once daily days 1-5; cycled every 21 days

standard adjuvant chemotherapy plus placebo

Standard adjuvant chemotherapy (Docetaxel combined with cyclophosphamide or doxorubicin combined with cyclophosphamide followed by docetaxel) plus placebo

Other Name: docetaxel 75mg/m^2, or nab-paclitaxel 260mg/m^2, IV, days 1 cyclophosphamide 1000 mg/m^2, IV, days 1, cycled every 21 days; or doxorubicin 60mg/m^2, IV, days 1, combined with cyclophosphamide 600 mg/m^2, IV, days 1, followed by docetaxel 75mg/m^2, or nab-paclitaxel 260mg/m^2, IV, days 1; plus Placebo 0.4 PO once daily days 1-5; cycled every 21 days

Group Type: PLACEBO_COMPARATOR

standard adjuvant chemotherapy plus placebo

Intervention Type: DRUG

docetaxel 75mg/m\^2, or nab-paclitaxel 260mg/m\^2, IV, days 1 cyclophosphamide 1000 mg/m\^2, IV, days 1, cycled every 21 days; or doxorubicin 60mg/m\^2, IV, days 1, cycled every 21 days cyclophosphamide 600 mg/m\^2, IV, days 1, cycled every 21 days docetaxel 100 mg/m\^2, IV, days 1, cycled every 21 days; plus Placebo 0.4 PO once daily days 1-5; cycled every 21 days

Interventions

standard adjuvant chemotherapy plus moxifloxacin

docetaxel 75mg/m\^2, or nab-paclitaxel 260mg/m\^2, IV, days 1 cyclophosphamide 1000 mg/m\^2, IV, days 1, cycled every 21 days; or doxorubicin 60mg/m\^2, IV, days 1, cycled every 21 days cyclophosphamide 600 mg/m\^2, IV, days 1, cycled every 21 days docetaxel 100 mg/m\^2, IV, days 1, cycled every 21 days; plus Moxifloxacin 0.4 PO once daily days 1-5; cycled every 21 days

Intervention Type: DRUG

standard adjuvant chemotherapy plus placebo

docetaxel 75mg/m\^2, or nab-paclitaxel 260mg/m\^2, IV, days 1 cyclophosphamide 1000 mg/m\^2, IV, days 1, cycled every 21 days; or doxorubicin 60mg/m\^2, IV, days 1, cycled every 21 days cyclophosphamide 600 mg/m\^2, IV, days 1, cycled every 21 days docetaxel 100 mg/m\^2, IV, days 1, cycled every 21 days; plus Placebo 0.4 PO once daily days 1-5; cycled every 21 days

Intervention Type: DRUG

Other Intervention Names

Standard adjuvant chemotherapy (Docetaxel combined with cyclophosphamide or doxorubicin combined with cyclophosphamide followed by docetaxel) plus antibiotic (moxifloxacin); Standard adjuvant chemotherapy (Docetaxel combined with cyclophosphamide or doxorubicin combined with cyclophosphamide followed by docetaxel) plus placebo

Eligibility Criteria

Inclusion Criteria

1. Have provided written and signed informed consent;

2. Histologically confirmed invasive ductal carcinoma;

3. Planned to received (neo)/adjuvant chemotherapy;

4. Eastern Cooperative Oncology Group (ECOG) score of 0 to 1;

5. Normal blood routine, liver and kidney functions within 1 week before enrollment in this study;

6. Women of childbearing age have a negative serum or urinary pregnancy tests prior to enrollment in this study; Pre-menopause women are contracepted with medically acceptable methods during the study period.

7. Compliance with the study protocol.

Exclusion Criteria

1. Pregnant or breast feeding;

2. Eastern Cooperative Oncology Group (ECOG) score ≥ 2;

3. Hypersensitivity to moxifloxacin or quinolones compounds;

4. Concomitant with other antitumor therapies or participating in other clinical trials;

5. Have a history of heart disease, such as arrhythmia, conduction block, S-T segment elevation, ischemic heart disease, or congenital heart disease;

6. Severe uncontrolled co-infection, or severe metabolic disorders;

7. A clear past history of neurological or psychiatric disorders, including epilepsy or dementia;

8. Poor compliance, unwillingness or inability to follow protocol to continue the study;

9. Any circumstances in which the investigator deemed the subject unsuitable for enrollment in this study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Zhong-yu Yuan

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

SYSUCC-015

Identifier Type: -

Identifier Source: org_study_id