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

NCT02115152 | Unknown Phase 2

• 1 other identifier: JLiu
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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).

Conditions

Stage II Breast Cancer; Stage III Breast Cancer

Keywords

Capecitabine; Neoadjuvant therapy; Early Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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.

• 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.

Study Arms (2)

FEC

ACTIVE COMPARATOR

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

XEC

EXPERIMENTAL

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

Interventions

fluorouracil DRUG

FEC

capecitabine DRUG

XEC

cyclophosphamide DRUG

FEC; XEC

Epirubicin DRUG

FEC; XEC

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Females aged 18-70 with histologically proven, core-biopsied, Stage II-III invasive breast cancer
• No distant disease

You may not qualify if:

• \- Inadequate heart or liver or kidney function

Sponsors & Collaborators

• Guangxi Medical University: lead

Study Sites (1)

Breast Cancer Surgery Department of Guangxi Medical University Cancer Center

Nanning, Guangxi, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Fluorouracil; Capecitabine; Cyclophosphamide; Epirubicin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Jianlun Liu, MD

  Guangxi Medical University Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianlun Liu

CONTACT

jianlunliu@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Breast Surgery

Study Record Dates

• First Submitted: March 24, 2014
• First Posted: April 15, 2014
• Study Start: June 1, 2014
• Primary Completion: June 1, 2018
• Last Updated: April 15, 2014

Record last verified: 2014-04

Locations

CN (1)