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

Sponsor

Guangxi Medical University (Other)

Overall Status

Unknown status

CT.gov ID

NCT02115152

Collaborator

(none)

100

Enrollment

Location

Arms

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Stage II Breast Cancer Stage III Breast Cancer	Drug: fluorouracil Drug: capecitabine Drug: cyclophosphamide Drug: Epirubicin	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 2014

Anticipated Primary Completion Date :

Jun 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: FEC Patients will be randomized to received 4 cycles of fluorouracil, epirubicin and cyclophosphamide before surgery, and 4 cycles of docetaxel after surgery.	Drug: fluorouracil Drug: cyclophosphamide Drug: Epirubicin
Experimental: XEC 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 Drug: cyclophosphamide Drug: Epirubicin

Arm

Intervention/Treatment

Active Comparator: FEC

Patients will be randomized to received 4 cycles of fluorouracil, epirubicin and cyclophosphamide before surgery, and 4 cycles of docetaxel after surgery.

Drug: fluorouracil

Drug: cyclophosphamide

Drug: Epirubicin

Experimental: XEC

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

Drug: cyclophosphamide

Drug: Epirubicin

Outcome Measures

Primary Outcome Measures

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

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.