Moxifloxacin in Adjuvant Treatment of Patients With Operable Breast Cancer

Sun Yat-sen University

Status and phase: Completed; Phase 3

Conditions: Breast Cancer

Treatments: Drug: standard adjuvant chemotherapy plus placebo; Drug: standard adjuvant chemotherapy plus moxifloxacin

Study type: Interventional

Funder types: Other

Identifiers

NCT05114720

SYSUCC-015

Details and patient eligibility

About

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.

Full 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.

Enrollment: 559 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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559 participants in 2 patient groups, including a placebo group

standard adjuvant chemotherapy plus moxifloxacin

Experimental group

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

Treatment:

Drug: standard adjuvant chemotherapy plus moxifloxacin

standard adjuvant chemotherapy plus placebo

Placebo Comparator group

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

Treatment:

Drug: standard adjuvant chemotherapy plus placebo