Stage II Breast Cancer, Stage III Breast Cancer
Conditions
Keywords
Capecitabine, Neoadjuvant therapy, Early Breast Cancer
Brief summary
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).
Interventions
DRUGfluorouracil
DRUGcapecitabine
DRUGcyclophosphamide
DRUGEpirubicin
Sponsors
Guangxi Medical University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pathologic response rates (pCR) | The breast sample will be evaluaed on the day of surgery during the cycle 4, an expected average of 12 weeks. | The absence of invasive tumor in the final surgical breast sample (stage yT0 or ypTis) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| DFS(Disease free survial) | 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. | 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 |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | Hematologic, renal, and hepatic funcion will be assessed after each cycle and at the end of therapy, an expected average of 3 weeks. | Adverse events are classified accoding NCI CTC criteria. |
Countries
China
Contacts
Primary ContactJianlun Liu
Outcome results
None listed