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

This study has been terminated.
(accrual too difficult to meet)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Baylor Breast Care Center
ClinicalTrials.gov Identifier:
NCT00206453
First received: September 14, 2005
Last updated: February 4, 2013
Last verified: February 2013
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


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 ]

Enrollment: 25
Study Start Date: January 2002
Study Completion Date: January 2005
Primary Completion Date: January 2005 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Taxotere
    Chemotherapy IV
    Other Name: Taxotere
  Show Detailed Description

  Eligibility

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

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

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
Investigators
Principal Investigator: Mothaffar Rimawi, MD Baylor Breast Center
  More Information

Additional Information:
No publications provided

Responsible Party: Baylor Breast Care Center
ClinicalTrials.gov Identifier: NCT00206453     History of Changes
Other Study ID Numbers: H-11058
Study First Received: September 14, 2005
Last Updated: February 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Baylor Breast Care Center:
Breast
Cancer
Gene
Expression
Taxotere

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014