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This randomized phase II trial compared pathologic response rates (pCR) of early breast cancer following neoadjuvant fluorouracil-epirubicin-cyclophosphamide(FEC) and capecitabine-epirubicin-cyclophosphamide (XEC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FEC | Active Comparator | Patients will be randomized to received 4 cycles of fluorouracil, epirubicin and cyclophosphamide before surgery, and 4 cycles of docetaxel after surgery. |
|
| XEC | Experimental | Patients will be randomized to received 4 cycles of capecitabine, epirubicin and cyclophosphamide before surgery, and 4 cycles of docetaxel and capecitabine after surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fluorouracil | Drug |
| ||
| capecitabine |
| Measure | Description | Time Frame |
|---|---|---|
| pathologic response rates (pCR) | The absence of invasive tumor in the final surgical breast sample (stage yT0 or ypTis) | The breast sample will be evaluaed on the day of surgery during the cycle 4, an expected average of 12 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| DFS(Disease free survial) | Time from randmization to breast-cancer recurrence, or a second primay cancer(ecluding contralateral ducal carcinoma in situ), or death from any cause, whichever comes first | Participants will be evaluated on Day 1 of each cycle during chemotherapy, and Day 1 every 3 months after completion of chemotherapy. The expected average of 5 years. |
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Inclusion Criteria:
Exclusion Criteria:
- Inadequate heart or liver or kidney function
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianlun Liu | Contact | jianlunliu@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Jianlun Liu, MD | Guangxi Medical University Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Breast Cancer Surgery Department of Guangxi Medical University Cancer Center | Nanning | Guangxi | China |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D005472 | Fluorouracil |
| D000069287 | Capecitabine |
| D003520 | Cyclophosphamide |
| D015251 | Epirubicin |
| ID | Term |
|---|---|
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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|
| cyclophosphamide | Drug |
|
| Epirubicin | Drug |
|
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | Adverse events are classified accoding NCI CTC criteria. | Hematologic, renal, and hepatic funcion will be assessed after each cycle and at the end of therapy, an expected average of 3 weeks. |
| D017437 |
| Skin and Connective Tissue Diseases |
| D006571 |
| Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D004317 | Doxorubicin |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |