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

Phase 2

• Conditions: Stage II Breast Cancer; Stage III Breast Cancer
• Interventions: Drug: fluorouracil; Drug: capecitabine; Drug: cyclophosphamide; Drug: Epirubicin

• Registration Number: NCT02115152
• Lead Sponsor: Guangxi Medical University

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-03-24
• Status Verified: 2014-04
• Study First Submitted QC: 2014-04-14
• Last Update Submitted: 2014-04-14
• Study First Posted: 2014-04-15
• Last Update Posted: 2014-04-15
• Study Start: 2014-06
• Primary Completion: 2018-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
FEC	fluorouracil	Patients will be randomized to received 4 cycles of fluorouracil, epirubicin and cyclophosphamide before surgery, and 4 cycles of docetaxel after surgery.
FEC	cyclophosphamide	Patients will be randomized to received 4 cycles of fluorouracil, epirubicin and cyclophosphamide before surgery, and 4 cycles of docetaxel after surgery.
FEC	Epirubicin	Patients will be randomized to received 4 cycles of fluorouracil, epirubicin and cyclophosphamide before surgery, and 4 cycles of docetaxel after surgery.
XEC	capecitabine	Patients will be randomized to received 4 cycles of capecitabine, epirubicin and cyclophosphamide before surgery, and 4 cycles of docetaxel and capecitabine after surgery.
XEC	cyclophosphamide	Patients will be randomized to received 4 cycles of capecitabine, epirubicin and cyclophosphamide before surgery, and 4 cycles of docetaxel and capecitabine after surgery.
XEC	Epirubicin	Patients will be randomized to received 4 cycles of capecitabine, epirubicin and cyclophosphamide before surgery, and 4 cycles of docetaxel and capecitabine after surgery.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Breast Cancer Surgery Department of Guangxi Medical University Cancer Center; 🇨🇳 Nanning, Guangxi, China