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Could a common antibiotic boost chemo for tough breast cancer?

NCT ID NCT04722978

Disease control Sponsor: Sun Yat-Sen University Cancer Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 3 trial is testing whether adding the antibiotic moxifloxacin to standard chemotherapy (gemcitabine and carboplatin) helps people with metastatic triple-negative breast cancer live longer without their cancer growing. About 228 participants will receive either the antibiotic or a placebo alongside chemo. The goal is to see if this combination improves progression-free survival.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
moxifloxacin (an antibiotic) plus gemcitabine and carboplatin (standard chemotherapy)
What this could lead to
If it works, this could offer a new, affordable first-line treatment option for metastatic triple-negative breast cancer by boosting the effectiveness of standard chemotherapy.
What could go wrong
This is a phase 3 trial, but adding an antibiotic to chemo may not improve survival and could increase side effects like nausea or antibiotic resistance. Results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 228 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2021

Expected to finish

Jul 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

triple-negative breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Triple-negative breast cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Sun Yat-sen University Cancer Center

    RECRUITING

    Guangzhou, Guangdong, 510060, China

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