- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02115152
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 Contact
- Name: Jianlun Liu
- Email: jianlunliu@hotmail.com
Study Locations
-
-
Guangxi
-
Nanning, Guangxi, China
- Breast Cancer Surgery Department of Guangxi Medical University Cancer Center
-
Contact:
- Jianlun Liu, MD
-
-
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.
|
|
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.
|
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
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
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antirheumatic Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antibiotics, Antineoplastic
- Cyclophosphamide
- Fluorouracil
- Capecitabine
- Epirubicin
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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