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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
47

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Taiwan
      • Taipei, Taiwan
        • Department of Oncology, National Taiwan University Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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：

    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

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: A
Drug: Docetaxel , Cisplatin , Capecitabine

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Taiwan University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2004

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2006

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 8, 2005

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 8, 2005

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 12, 2005

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 25, 2007

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2007

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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