Advanced Breast CancerPhase 2NCT03405168
Routine Therapy Plus Moxifloxacin in Advanced Breast Cancer
A Phase 2 study testing Moxifloxacin Hydrochloride 400mg Tablet in people with Advanced Breast Cancer and Antibiotic, run by Sun Yat-sen University at 1 site in China.
Trial summary
This is a phase II,single center,prospective, single arm clinical trial. The objective is to evaluate the efficacy and safety of routine therapy plus moxifloxacin in Advanced Breast Cancer whose evaluation is stable disease with a trend of progression. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Advanced Breast Cancer, Antibiotic, Stable Disease With a Trend of Progression
- What is being tested?
- Moxifloxacin Hydrochloride 400mg Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 30 Jul 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female ≥ 18 years, ≤70 years.
- Has measurable metastatic MBC, with at least 1 measurable lesion per RECIST criteria.
- Fail first-line or above anti-tumor treatment
- Evaluation is stable disease with a trend of progression.
- Minimum life expectancy 16 weeks
- Histological confirmation of breast cancer on primary tumour at diagnosis/on biopsy of metastasis
Show all 9Show fewer
- ECOG Performance Status (PS) 0-2 with no deterioration over previous 2 weeks
- Normal organ function.
- Has signed a Patient Informed Consent Form
Who cannot join
- Hypersensitivity to moxifloxacin or other quinolones.
- Tendon damage,peripheral neuropathy,myasthenia gravis.
- Rapidly progressive visceral disease not suitable for further therapy.
- Evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, active bleeding diatheses, or active infection including hepatitis B, hepatitis C and HIV
- With the exception of alopecia, any unresolved toxicities from previous therapy greater than CTCAE grade 1 before study treatment
- Evidence of dementia, altered mental status or any psychiatric condition that would prohibit understanding or rendering of informed consent
- Inability or unwillingness to comply with study procedures, including inability to take regular oral medication
- Researchers consider it is not suitable for participation.
Trial locations and contacts
1 site in 1 country.
About this study
This is a phase II,single center,prospective, single arm clinical trial. The objective is to evaluate the efficacy and safety of routine therapy plus moxifloxacin in Advanced Breast Cancer whose evaluation is stable disease with a trend of progression.
Read the detailed description
This is a phase II,single center,prospective, single arm clinical trial. A lot of in vitro and in vivo study demonstrate that quinolones antibiotics can increase anti-tumor effect. The objective is to evaluate the efficacy and safety of routine therapy plus moxifloxacin in Advanced Breast Cancer whose evaluation is stable disease with a trend of progression.
- Being tested
- Moxifloxacin Hydrochloride 400mg Tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moxifloxacin Hydrochloride 400mg TabletDrug
Moxifloxacin is oral administration, 400 mg once a day, D1 to D7, 28 days as one cycle.
| Study group | Role | What they receive |
|---|---|---|
| routine therapy plus moxifloxacin | Experimental | Routine therapy (chemotherapy, endocrine therapy or target therapy) is according to physician's choice. Receives: Drug: Moxifloxacin Hydrochloride 400mg Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival (PFS)
the time from the beginning of treatment for metastatic breast cancer to disease progression or death from any cause
Measured: 1years
Secondary outcomes (3)
objective response rate (ORR)
the proportion of patients with tumor size reduction of a predefined amount and for a minimum time period
Measured: 6 months
clinical benefit rate (CBR)
the proportion of patients with tumors complete response, partial response, and stable disease
Measured: 6 months
overal survival(OS)
the time from the beginning of treatment for metastatic breast cancer to death from any cause
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2018
- Study start1 Jan 2018
- Primary completion30 Jul 2018
- Study completion30 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Breast CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhong-yu Yuan, Sun Yat-sen University
- Investigators
- jiajia huang, Study director, Sun-yatsen University Cancer center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03405168
- Sponsor's protocol ID
- SYSUCC-008
- Status last verified
- Nov 2018
- First submitted
- 14 Jan 2018
- Last updated
- 16 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wang X, Li J, Shi W, Huang Z, Xia W, Huang J, Su Y, Wang S, Shi Y, Bi X, Yuan Z. Efficacy of Moxifloxacin plus Treatment of Physician's Choice in Patients with Metastatic Breast Cancer. Oncologist. 2020 Oct;25(10):e1439-e1445. doi: 10.1634/theoncologist.2020-0364. Epub 2020 Jun 1.
PubMed 32390277
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Routine Therapy Plus Moxifloxacin in Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT03405168
- Acronym / sponsor ID
- SYSUCC-008
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Jul 2018 (actual)
- Study completion
- 30 Jul 2018 (actual)
- First posted
- 19 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase II,single center,prospective, single arm clinical trial. The objective is to evaluate the efficacy and safety of routine therapy plus moxifloxacin in Advanced Breast Cancer whose evaluation is stable disease with a trend of progression.
Detailed description
This is a phase II,single center,prospective, single arm clinical trial. A lot of in vitro and in vivo study demonstrate that quinolones antibiotics can increase anti-tumor effect. The objective is to evaluate the efficacy and safety of routine therapy plus moxifloxacin in Advanced Breast Cancer whose evaluation is stable disease with a trend of progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| routine therapy plus moxifloxacin | Experimental | Drug: Moxifloxacin Hydrochloride 400mg TabletRoutine therapy (chemotherapy, endocrine therapy or target therapy) is according to physician's choice. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Female ≥ 18 years, ≤70 years.
- Has measurable metastatic MBC, with at least 1 measurable lesion per RECIST criteria.
- Fail first-line or above anti-tumor treatment
- Evaluation is stable disease with a trend of progression.
- Minimum life expectancy 16 weeks
Key exclusion criteria (8 listed)
- Hypersensitivity to moxifloxacin or other quinolones.
- Tendon damage,peripheral neuropathy,myasthenia gravis.
- Rapidly progressive visceral disease not suitable for further therapy.
- Evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension, active bleeding diatheses, or active infection including hepatitis B, hepatitis C and HIV
- With the exception of alopecia, any unresolved toxicities from previous therapy greater than CTCAE grade 1 before study treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moxifloxacin Hydrochloride 400mg TabletMoxifloxacin is oral administration, 400 mg once a day, D1 to D7, 28 days as one cycle. | Drug | routine therapy plus moxifloxacin |
Primary outcome
progression-free survival (PFS)
Time frame: 1years
the time from the beginning of treatment for metastatic breast cancer to disease progression or death from any cause
3 secondary outcomes
objective response rate (ORR)
Time frame: 6 months
clinical benefit rate (CBR)
Time frame: 6 months
overal survival(OS)
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2018.
- Derived from this study: PubMed 32390277Wang X, Li J, Shi W, Huang Z, Xia W, Huang J, Su Y, Wang S, Shi Y, Bi X, Yuan Z. Efficacy of Moxifloxacin plus Treatment of Physician's Choice in Patients with Metastatic Breast Cancer. Oncologist. 2020 Oct;25(10):e1439-e1445. doi: 10.1634/theoncologist.2020-0364. Epub 2020 Jun 1.
Related trials for Advanced Breast Cancer
Active, not recruitingPhase 1/2
Phase I/II Study of the Anti-Programmed Death Ligand-1 Durvalumab Antibody (MEDI4736) in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Can...
Colorectal Neoplasms, Breast Neoplasms
RecruitingPhase 1/2
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
Metastatic Breast Cancer
Active, not recruitingPhase 2
Testing GDC-0032 (Taselisib) as a Potential Targeted Treatment in Cancers With PIK3CA Genetic Changes (MATCH-Subprotocol I)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Active, not recruitingPhase 1
A Phase 1 Study of XL309 (ISM3091) Alone and in Combination in Participants With Advanced Solid Tumors
Advanced Solid Tumor
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
jiajia huang study director
Sun-yatsen University Cancer center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Moxifloxacin Hydrochloride 400mg Tablet in people with Advanced Breast Cancer and Antibiotic, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression-free survival (PFS) (time frame: 1years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03405168, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2018.