Neoadjuvant Trial of Capecitabine for Axillary Lymph Node Positive Operable Breast Cancer

Study Overview
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Brief Summary
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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).

Official Title
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Phase II Neoadjuvant Trial of Capecitabine, Cyclophosphamide and Epirubicin for Patients With Axillary Lymph Node Positive Stage II-III Operable Breast Cancer

Conditions
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Stage II Breast Cancer, Stage III Breast Cancer

Intervention / Treatment
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* Drug: fluorouracil
* Drug: capecitabine
* Drug: cyclophosphamide
* Drug: Epirubicin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Females aged 18-70 with histologically proven, core-biopsied, Stage II-III invasive breast cancer No distant disease Exclusion Criteria: - Inadequate heart or liver or kidney function

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: FEC<br>Patients will be randomized to received 4 cycles of fluorouracil, epirubicin and cyclophosphamide before surgery, and 4 cycles of docetaxel after surgery. | Drug: fluorouracil<br> <br> Drug: cyclophosphamide<br> <br> Drug: Epirubicin<br> <br> |
| Experimental: XEC<br>Patients will be randomized to received 4 cycles of capecitabine, epirubicin and cyclophosphamide before surgery, and 4 cycles of docetaxel and capecitabine after surgery. | Drug: capecitabine<br> <br> Drug: cyclophosphamide<br> <br> Drug: Epirubicin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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. | 
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Capecitabine, Neoadjuvant therapy, Early Breast Cancer