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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| routine therapy plus moxifloxacin | Experimental | Routine therapy (chemotherapy, endocrine therapy or target therapy) is according to physician's choice. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moxifloxacin Hydrochloride 400mg Tablet | Drug | Moxifloxacin is oral administration, 400 mg once a day, D1 to D7, 28 days as one cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| progression-free survival (PFS) | the time from the beginning of treatment for metastatic breast cancer to disease progression or death from any cause | 1years |
| Measure | Description | Time Frame |
|---|---|---|
| objective response rate (ORR) | the proportion of patients with tumor size reduction of a predefined amount and for a minimum time period | 6 months |
| clinical benefit rate (CBR) | the proportion of patients with tumors complete response, partial response, and stable disease |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| jiajia huang | Sun-yatsen University Cancer center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongyu Yuan | Guangzhou | Guangdong | 510000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32390277 | Derived | 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. |
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| ID | Term |
|---|---|
| D000077266 | Moxifloxacin |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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| 6 months |
| overal survival(OS) | the time from the beginning of treatment for metastatic breast cancer to death from any cause | 3 years |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |