Moxifloxacin in Adjuvant Treatment of Patients With Operable Breast Cancer

Breast Cancer Clinical Trial

Official title:

A Multicenter, Placebo-Controlled, Phase III Trial of Standard Adjuvant Chemotherapy Plus Moxifloxacin in Operable Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05114720
• Other study ID #: SYSUCC-015
• Status: Recruiting
• Phase: Phase 3
• Start date: November 11, 2021
• Est. completion date: December 2028

Study information

• Verified date: November 2021
• Source: Sun Yat-sen University
• Contact: Zhongyu Yuan, Professor
• Phone: +862087343794
• Email: yuanzhy[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 520
• Est. completion date: December 2028
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• 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
• 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

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	disease-free survival (DFS)	The interval from the date of randomization until the first date of recurrence local, regional or distant, second primary tumor or death due to any cause	10 years
Secondary	overall survival (OS)	The interval from the date of randomization until the first date on death due to any cause, or the last follow-up time	10 years
Secondary	distant disease-free survival (DDFS)	The interval from the date of randomization until the first date on distant metastasis, death due to any cause, or second primary invasive breast cancer	10 years