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Moxifloxacin in Adjuvant Treatment of Patients With Operable Breast Cancer

Primary Purpose

Breast Cancer

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
standard adjuvant chemotherapy plus moxifloxacin
standard adjuvant chemotherapy plus placebo
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring moxifloxacin, operable breast cancer, adjuvant treatment, disease-free survival, safety

Eligibility Criteria

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

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.

Sites / Locations

  • Sun Yat-sen University Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

standard adjuvant chemotherapy plus moxifloxacin

standard adjuvant chemotherapy plus placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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

Full Information

First Posted
November 2, 2021
Last Updated
November 14, 2021
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT05114720
Brief Title
Moxifloxacin in Adjuvant Treatment of Patients With Operable Breast Cancer
Official Title
A Multicenter, Placebo-Controlled, Phase III Trial of Standard Adjuvant Chemotherapy Plus Moxifloxacin in Operable Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
November 11, 2021 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2028 (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
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
moxifloxacin, operable breast cancer, adjuvant treatment, disease-free survival, safety

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
520 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
standard adjuvant chemotherapy plus moxifloxacin
Arm Type
Experimental
Arm Description
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
Arm Title
standard adjuvant chemotherapy plus placebo
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
standard adjuvant chemotherapy plus moxifloxacin
Other Intervention Name(s)
Standard adjuvant chemotherapy (Docetaxel combined with cyclophosphamide or doxorubicin combined with cyclophosphamide followed by docetaxel) plus antibiotic (moxifloxacin)
Intervention Description
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
Intervention Name(s)
standard adjuvant chemotherapy plus placebo
Other Intervention Name(s)
Standard adjuvant chemotherapy (Docetaxel combined with cyclophosphamide or doxorubicin combined with cyclophosphamide followed by docetaxel) plus placebo
Intervention Description
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
Primary Outcome Measure Information:
Title
disease-free survival (DFS)
Description
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
Time Frame
10 years
Secondary Outcome Measure Information:
Title
overall survival (OS)
Description
The interval from the date of randomization until the first date on death due to any cause, or the last follow-up time
Time Frame
10 years
Title
distant disease-free survival (DDFS)
Description
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
Time Frame
10 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Have provided written and signed informed consent; Histologically confirmed invasive ductal carcinoma; Planned to received (neo)/adjuvant chemotherapy; Eastern Cooperative Oncology Group (ECOG) score of 0 to 1; Normal blood routine, liver and kidney functions within 1 week before enrollment in this study; 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. Compliance with the study protocol. Exclusion Criteria: Pregnant or breast feeding; Eastern Cooperative Oncology Group (ECOG) score ≥ 2; Hypersensitivity to moxifloxacin or quinolones compounds; Concomitant with other antitumor therapies or participating in other clinical trials; Have a history of heart disease, such as arrhythmia, conduction block, S-T segment elevation, ischemic heart disease, or congenital heart disease; Severe uncontrolled co-infection, or severe metabolic disorders; A clear past history of neurological or psychiatric disorders, including epilepsy or dementia; Poor compliance, unwillingness or inability to follow protocol to continue the study; Any circumstances in which the investigator deemed the subject unsuitable for enrollment in this study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhongyu Yuan, Professor
Phone
+862087343794
Email
yuanzhy@sysucc.org.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Yuanyi Zhong, MD
Phone
862087342496
Email
zhongyy@sysucc.org.cn
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, M.D.
Phone
86-20-87343794
Email
yuanzhy@sysucc.org.cn

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
We decided to not share our individual participant data (IPD) to other researchers.

Learn more about this trial

Moxifloxacin in Adjuvant Treatment of Patients With Operable Breast Cancer

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