Back to resultsNeoadjuvant Trial of Capecitabine for Axillary Lymph Node Positive Operable Breast Cancer
Primary Purpose
Stage II Breast Cancer, Stage III Breast Cancer
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
fluorouracil
capecitabine
cyclophosphamide
Epirubicin
Sponsored by
About this trial
This is an interventional treatment trial for Stage II Breast Cancer focused on measuring Capecitabine, Neoadjuvant therapy, Early Breast Cancer
Eligibility Criteria
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
Sites / Locations
- Breast Cancer Surgery Department of Guangxi Medical University Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
FEC
XEC
Arm Description
Patients will be randomized to received 4 cycles of fluorouracil, epirubicin and cyclophosphamide before surgery, and 4 cycles of docetaxel after surgery.
Patients will be randomized to received 4 cycles of capecitabine, epirubicin and cyclophosphamide before surgery, and 4 cycles of docetaxel and capecitabine after surgery.
Outcomes
Primary Outcome Measures
pathologic response rates (pCR)
The absence of invasive tumor in the final surgical breast sample (stage yT0 or ypTis)
Secondary Outcome Measures
DFS(Disease free survial)
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
Adverse events are classified accoding NCI CTC criteria.
Full Information
NCT ID
NCT02115152
First Posted
March 24, 2014
Last Updated
April 14, 2014
Sponsor
Guangxi Medical University
1. Study Identification
Unique Protocol Identification Number
NCT02115152
Brief Title
Neoadjuvant Trial of Capecitabine for Axillary Lymph Node Positive Operable Breast Cancer
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 Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Unknown status
Study Start Date
June 2014 (undefined)
Primary Completion Date
June 2018 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangxi Medical University
4. Oversight
Data Monitoring Committee
No
5. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage II Breast Cancer, Stage III Breast Cancer
Keywords
Capecitabine, Neoadjuvant therapy, Early Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
FEC
Arm Type
Active Comparator
Arm Description
Patients will be randomized to received 4 cycles of fluorouracil, epirubicin and cyclophosphamide before surgery, and 4 cycles of docetaxel after surgery.
Arm Title
XEC
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
fluorouracil
Intervention Type
Drug
Intervention Name(s)
capecitabine
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
Epirubicin
Primary Outcome Measure Information:
Title
pathologic response rates (pCR)
Description
The absence of invasive tumor in the final surgical breast sample (stage yT0 or ypTis)
Time Frame
The breast sample will be evaluaed on the day of surgery during the cycle 4, an expected average of 12 weeks.
Secondary Outcome Measure Information:
Title
DFS(Disease free survial)
Description
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
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.
Title
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Description
Adverse events are classified accoding NCI CTC criteria.
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.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jianlun Liu
Email
jianlunliu@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianlun Liu, MD
Organizational Affiliation
Guangxi Medical University Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Breast Cancer Surgery Department of Guangxi Medical University Cancer Center
City
Nanning
State/Province
Guangxi
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianlun Liu, MD
12. IPD Sharing Statement
Learn more about this trial
Neoadjuvant Trial of Capecitabine for Axillary Lymph Node Positive Operable Breast Cancer
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