Extension Neoadjuvant Taxotere: Study of the Effects of Taxotere in Patients With Breast Cancer - Full Text View

Sponsor:	Baylor Breast Care Center
Collaborator:	Department of Defense
Information provided by:	Baylor Breast Care Center
ClinicalTrials.gov Identifier:	NCT00206453

Purpose

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	Intervention	Phase
Breast Cancer	Drug: Taxotere	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Official Title:	An Extension Phase II Study of the Clinical and Biologic Effects of Docetaxel (Taxotere) in Patients With Locally Advanced Breast Cancer

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Docetaxel

U.S. FDA Resources

Further study details as provided by Baylor Breast Care Center:

Primary Outcome Measures:

biologic effects of Taxotere [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

comparison of histologic and molecular markers from sequential core biopsies of primary breast cancers of patients receiving Taxotere [ Time Frame: 10 year ] [ Designated as safety issue: No ]
expression arrays will be used [ Time Frame: 10 year ] [ Designated as safety issue: No ]

Estimated Enrollment:	70
Study Start Date:	January 2002
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	January 2007 (Final data collection date for primary outcome measure)

Intervention Details:

Chemotherapy IV

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

All patients must be female
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.
Negative serum pregnancy test (beta-human chorionic gonadotropin [b-HCG]) within 7 days of starting study, if of childbearing potential
Kidney and liver function tests - all within 1.5 times of the institution's upper limit of normal
Performance status (World Health Organization [WHO] scale) < 2 and life expectancy > 6 months
Age > 18 years old
No brain and/or leptomeningeal disease
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:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00206453

Locations

United States, Texas
Baylor Breast Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

Baylor Breast Care Center

Department of Defense

Investigators

Principal Investigator:

Jenny Chang, MD

Baylor Breast Center

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Baylor College of Medicine, Breast Center ( Jenny Chang, MD )
Study ID Numbers:	H-11058
Study First Received:	September 14, 2005
Last Updated:	January 5, 2009
ClinicalTrials.gov Identifier:	NCT00206453 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Baylor Breast Care Center:

Breast
Cancer
Gene
Expression
Taxotere

Additional relevant MeSH terms:

Docetaxel
Neoplasms
Neoplasms by Site
Skin Diseases
Antineoplastic Agents

Therapeutic Uses
Breast Neoplasms
Pharmacologic Actions
Breast Diseases

ClinicalTrials.gov processed this record on November 05, 2009