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TA Base Rate
Adjusted LOA
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Fixed-dose combination of capecitabine and cyclophosphamide SAR439281 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| SAR439281(Cohort 1) | EXPERIMENTAL | Regimen 1: one full-dose tablet containing capecitabine and cyclophosphamide, given BID without interruption |
| SAR439281(Cohort 2) | EXPERIMENTAL | Regimen 2: two tablets containing capecitabine and cyclophosphamide, given OD without interruption |
| SAR439281(Cohort 3) | EXPERIMENTAL | Regimen 3: one tablet containing capecitabine and cyclophosphamide, given OD without interruption |
| Name | Type | Description |
|---|---|---|
| Fixed-dose combination of capecitabine and cyclophosphamide SAR439281 | DRUG | Pharmaceutical form:Tablet Route of administration: Oral |
Inclusion criteria: * Female ≥18 and ≤65 years old. * Patients with histologically or cytologically confirmed Metastatic Breast Cancer (HER2 negative, ER/PR positive or negative), who are candidates to receive capecitabine and cyclophosphamide as per Investigator's judgment, and meet either one of ...
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