- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00155259
Docetaxel, Cisplatin and Capecitabine as Neoadjuvant Chemotherapy for Locally Advanced Breast Cancer
July 23, 2007 updated by: National Taiwan University Hospital
Docetaxel by 1 Hour Infusion Followed by 24 Hour Infusion of Cisplatin Plus Capecitabine as Neoadjuvant Chemotherapy for Locally Advanced Breast Cancer
The primary endpoint of this phase II trial is the objective response rate of the regimen.
The secondary endpoints include treatment-related toxicity, progression free survival and overall survival and breast conserving rate.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is an open-label phase II trial designed to test the effect and toxicity profile of combination of docetaxel, cisplatin, and capecitabine in locally advanced breast cancer patients.Breast cancer is one of the leading causes of cancer death for women in Taiwan.
Despite the advance in multidisciplinary treatment, a significant number of patients eventually develop metastatic disease, especially those who present with locally advanced breast cancer (LABC).
LABC remains an important and challenging problem in practice.
In LABC, treatment strategies that include neoadjuvant chemotherapy have several potential advantages: early initiation of systemic therapy, in vivo assessment of response, and downstaging of primary tumor and regional lymphatic metastases, which makes breast-conserving surgery an option for many.
The potential theoretical shortcomings include delay in local treatment, introduction of drug resistance, and unreliability of clinical staging.
In practice, the advantages have exceeded the disadvantages.
Clinical trial has demonstrated that docetaxel and capecitabine is highly effective in the treatment of metastatic breast cancer.
On the other hand, our previous study has demonstrated that combination of taxane and cisplatin is highly effective in the treatment of locally advanced and metastatic breast cancer.
We design a combination chemotherapy using docetaxel with cisplatin and capecitabine in the treatment of locally advanced breast cancer.
Study Type
Interventional
Enrollment (Actual)
47
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
-
-
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Taipei, Taiwan
- Department of Oncology, National Taiwan University Hospital
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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
No older than 65 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
Women with histological proven LABC, without metastasis, and no prior therapy. LABC is defined as follows:
- Tumor more than 5 cm in diameter
- Tumor involvement of chest wall (ribs or intercostals or serratus anterior muscles) or skin (ipsilateral cutaneous edema, ulceration, or satellite nodules)
- Clinical evident inflammatory carcinoma
- Ipsilateral fixed axillary adenopathy
- Measurable disease by physical examination, breast sonography and other image study
- KPS≧ 70%
- Adequate bone marrow reserve, defined as white blood cell (WBC)≧ 3,500/ mm3, absolute neutrophil count (ANC)≧ 1,500/mm3, platelets ≧ 100,000/mm3
- Adequate liver and kidney function: total bilirubin ≦ 2.0 mg/dl, serum alanine transaminases (ALT) and aspartate transaminase (AST) ≦ 3 times upper normal limit, serum creatinine ≦ 1.5 mg/dl
- Patients must be ≦ 65 years old
- Signed informed consent
Exclusion Criteria:
- Patients who have received prior treatment (including hormonal therapy, chemotherapy, radiotherapy or biological therapy) for LABC. Concomitant use of above therapy will no be allowed.
- Pregnant or lactating woman
- Metastases disease other than regional lymph node metastases (supraclavicular lymph node metastases is not eligible)
- Prior serious cardiac conditions such as angina, myocardial infarction, cardiomyopathy, severe cardiovascular disease or cardiac arrhythmias
- Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator)
- Secondary malignancy in past five years before entry of the study (except in situ carcinoma of the cervix, or adequately treated basal cell carcinoma of the skin)
- Active infection (at the discretion of the investigator)
- Significant neurological (such as seizures) or psychiatric disorder
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: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: A
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The primary endpoint of this phase II trial is the objective response rate of the regimen.
Time Frame: 2005~2006
|
2005~2006
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The secondary endpoints include treatment-related toxicity, progression free survival and overall survival and breast conserving rate.
Time Frame: 2005~2006
|
2005~2006
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Yen-Shen Lu, M.D., Department of Oncology , National Taiwan University Hospital
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
October 1, 2004
Study Completion (Actual)
December 1, 2006
Study Registration Dates
First Submitted
September 8, 2005
First Submitted That Met QC Criteria
September 8, 2005
First Posted (Estimate)
September 12, 2005
Study Record Updates
Last Update Posted (Estimate)
July 25, 2007
Last Update Submitted That Met QC Criteria
July 23, 2007
Last Verified
July 1, 2005
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 930607
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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