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To compare the efficacy and safety of capecitabine and cyclophosphamide (XC) versus physician's choice as maintenance therapy for patients with advanced breast cancer who achieved disease control after salvage treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| capecitabine and cyclophosphamide (XC) | Experimental | capecitabine and cyclophosphamide as maintenance therapy every 3 weeks |
|
| physician's choice | Active Comparator | Any physician's choice as maintenance therapy (except for XC regimen). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XC | Drug | Capecitabine (bid po, d1-14) and cyclophosphamide (qd po, d1-d14) every 21 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | PFS is defined as the time from the date of starting maintenance therapy to the date of disease progression or death from any cause, whichever occurs first. | From the date of starting maintenance therapy to the date of first documentation of disease progression or death from any cause (up to approximately 1 year) |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Adverse events during maintenance therapy will be assessed according to the NCI CTCAE v5.0. | From the date of starting maintenance therapy to the end of the treatment (up to approximately 1 year)] |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wenjin Yin, M.D. | Contact | 86(21)68385569 | yinwenjin@renji.com |
| Name | Affiliation | Role |
|---|---|---|
| Wenjin Yin, M.D. | Renji Hospital,School of Medicine, Shanghai Jiaotong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Renji Hospital, School of Medicine, Shanghai Jiaotong University | Recruiting | Shanghai | 200127 | China |
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| TPC | Drug | Any physician's choice as maintenance therapy (except for XC regimen) |
|