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

Guangxi Medical University

Status and phase: Unknown; Phase 2

Conditions: Stage II Breast Cancer; Stage III Breast Cancer

Treatments: Drug: capecitabine; Drug: cyclophosphamide; Drug: Epirubicin; Drug: fluorouracil

Study type: Interventional

Funder types: Other

Identifiers

NCT02115152

JLiu

Details and patient eligibility

About

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).

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

FEC

Active Comparator group

Description:

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

Treatment:

Drug: fluorouracil

Drug: cyclophosphamide

Drug: Epirubicin

XEC

Experimental group

Description:

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

Treatment:

Drug: cyclophosphamide

Drug: capecitabine

Drug: Epirubicin