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Docetaxel, Cisplatin and Capecitabine as Neoadjuvant Chemotherapy for Locally Advanced Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00155259
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : July 25, 2007
Sponsor:
Information provided by:
National Taiwan University Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Docetaxel , Cisplatin , Capecitabine Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Docetaxel by 1 Hour Infusion Followed by 24 Hour Infusion of Cisplatin Plus Capecitabine as Neoadjuvant Chemotherapy for Locally Advanced Breast Cancer
Study Start Date : October 2004
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: A Drug: Docetaxel , Cisplatin , Capecitabine



Primary Outcome Measures :
  1. The primary endpoint of this phase II trial is the objective response rate of the regimen. [ Time Frame: 2005~2006 ]

Secondary Outcome Measures :
  1. The secondary endpoints include treatment-related toxicity, progression free survival and overall survival and breast conserving rate. [ Time Frame: 2005~2006 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women with histological proven LABC, without metastasis, and no prior therapy. LABC is defined as follows:

    1. Tumor more than 5 cm in diameter
    2. Tumor involvement of chest wall (ribs or intercostals or serratus anterior muscles) or skin (ipsilateral cutaneous edema, ulceration, or satellite nodules)
    3. Clinical evident inflammatory carcinoma
    4. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00155259


Locations
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Taiwan
Department of Oncology, National Taiwan University Hospital
Taipei, Taiwan
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Principal Investigator: Yen-Shen Lu, M.D. Department of Oncology , National Taiwan University Hospital

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ClinicalTrials.gov Identifier: NCT00155259    
Other Study ID Numbers: 930607
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: July 25, 2007
Last Verified: July 2005
Keywords provided by National Taiwan University Hospital:
Breast Cancer , Neoadjuvant Chemotherapy
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cisplatin
Docetaxel
Capecitabine
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites