Extension Neoadjuvant Taxotere: Study of the Effects of Taxotere in Patients With Breast Cancer

NCT00206453 | Terminated Phase 2

• 1 other identifier: H-11058
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Breast; Cancer; Gene; Expression; Taxotere

Outcome Measures

Primary Outcomes (2)

• biologic effects of Taxotere

  1 year

• to identify gene expression profiles predictive of response and to further describe the efficacy of Taxotere in women with locally advanced breast cancer

  1 year

Secondary Outcomes (2)

• comparison of histologic and molecular markers from sequential core biopsies of primary breast cancers of patients receiving Taxotere

  10 year

• expression arrays will be used

  10 year

Interventions

Taxotere DRUG

Chemotherapy IV

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baylor Breast Care Center: lead
• United States Department of Defense: collaborator

Study Sites (1)

Baylor Breast Center

Houston, Texas, 77030, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Breast Neoplasms; Neoplasms

Interventions

Docetaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Mothaffar Rimawi, MD

  Baylor Breast Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2005
• First Posted: September 21, 2005
• Study Start: January 1, 2002
• Primary Completion: January 1, 2005
• Study Completion: January 1, 2005
• Last Updated: February 5, 2013

Record last verified: 2013-02

Locations

US (1)