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Extension Neoadjuvant Taxotere: Study of the Effects of Taxotere in Patients With 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. Identifier: NCT00206453
Recruitment Status : Terminated (accrual too difficult to meet)
First Posted : September 21, 2005
Last Update Posted : February 5, 2013
United States Department of Defense
Information provided by (Responsible Party):
Baylor Breast Care Center

Brief Summary:
We, the investigators at Baylor Breast Care Cancer, are doing this study to learn how well Taxotere makes tumors become smaller. We are also doing this study to find out how well Taxotere treats the type of breast cancer that some patients have. We are asking patients to take part in this study because they have locally advanced breast cancer. Women with this breast cancer will usually receive chemotherapy medicines to reduce or shrink the cancer before surgery to take out the cancer. If patients choose to take part in this study, they will receive Taxotere and the combination of cyclophosphamide and doxorubicin. These medicines are part of the standard good medical care for this type of breast cancer. They are approved for the treatment of this problem. To help us learn how the patients' cancer responds to these medicines, we will take a small tissue sample (biopsy) of the patients' breast cancer before beginning treatment, one day after the first dose of treatment, once each week for the first three weeks of treatment, and when surgery is done as part of treatment for their cancer. These samples will be collected also to look at the biology of the patients' cancer. We will also use a new method called cDNA array technology, which lets us look at thousands of genes (coding information inside the cancer cell) at once. By looking at different genes in the breast cancer, we may learn important information about which cancers will respond to a chemotherapy medicine. We hope to learn if there are different gene patterns in patients whose tumors shrink or do not shrink with this chemotherapy medicine. This information may help us, in the future, to choose the right medicines for women with breast cancer so that they have the highest chance of their cancer shrinking with chemotherapy medicine. We cannot and do not know if patients will benefit if they take part in this study.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Taxotere Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Extension Phase II Study of the Clinical and Biologic Effects of Docetaxel (Taxotere) in Patients With Locally Advanced Breast Cancer
Study Start Date : January 2002
Actual Primary Completion Date : January 2005
Actual Study Completion Date : January 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Docetaxel

Intervention Details:
  • Drug: Taxotere
    Chemotherapy IV

Primary Outcome Measures :
  1. biologic effects of Taxotere [ Time Frame: 1 year ]
  2. to identify gene expression profiles predictive of response and to further describe the efficacy of Taxotere in women with locally advanced breast cancer [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. comparison of histologic and molecular markers from sequential core biopsies of primary breast cancers of patients receiving Taxotere [ Time Frame: 10 year ]
  2. expression arrays will be used [ Time Frame: 10 year ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. All patients must be female
  2. Locally advanced breast cancers or primary breast cancers with concomitant gross metastatic disease are eligible; locally advanced cancers must be of clinical and/or radiologic size > 4 cm and/or are deemed surgically inoperable.
  3. Negative serum pregnancy test (beta-human chorionic gonadotropin [b-HCG]) within 7 days of starting study, if of childbearing potential
  4. Kidney and liver function tests - all within 1.5 times of the institution's upper limit of normal
  5. Performance status (World Health Organization [WHO] scale) < 2 and life expectancy > 6 months
  6. Age > 18 years old
  7. No brain and/or leptomeningeal disease
  8. No previous or current malignancies at other sites within the last 5 years, with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin.

Exclusion Criteria:

  1. Pregnancy or unwillingness to use a reliable contraceptive method in women of child-bearing potential.
  2. Severe underlying chronic illness or disease
  3. Patients on other investigational drugs while on study will be excluded.

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 identifier (NCT number): NCT00206453

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United States, Texas
Baylor Breast Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor Breast Care Center
United States Department of Defense
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Principal Investigator: Mothaffar Rimawi, MD Baylor Breast Center

Additional Information:
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Responsible Party: Baylor Breast Care Center Identifier: NCT00206453     History of Changes
Other Study ID Numbers: H-11058
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: February 5, 2013
Last Verified: February 2013
Keywords provided by Baylor Breast Care Center:
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action