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

April 14, 2014 updated by: Jianlun Liu, Guangxi Medical University

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

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangxi
      • Nanning, Guangxi, China
        • Breast Cancer Surgery Department of Guangxi Medical University Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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: cyclophosphamide
Drug: Epirubicin
Drug: fluorouracil
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: cyclophosphamide
Drug: Epirubicin
Drug: capecitabine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pathologic response rates (pCR)
Time Frame: 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)
The breast sample will be evaluaed on the day of surgery during the cycle 4, an expected average of 12 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DFS(Disease free survial)
Time Frame: 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
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
Time Frame: 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.
Hematologic, renal, and hepatic funcion will be assessed after each cycle and at the end of therapy, an expected average of 3 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangxi Medical University

Investigators

  • Principal Investigator: Jianlun Liu, MD, Guangxi Medical University Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Anticipated)

June 1, 2018

Study Registration Dates

First Submitted

March 24, 2014

First Submitted That Met QC Criteria

April 14, 2014

First Posted (Estimate)

April 15, 2014

Study Record Updates

Last Update Posted (Estimate)

April 15, 2014

Last Update Submitted That Met QC Criteria

April 14, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JLiu

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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