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Evaluation of Tumor Factors in Breast Cancer Treated With Docetaxel and Capecitabine

Evaluation of Thymidine Phosphorylase and Other Predictive/Prognostic Factors in Primary Breast Cancer Treated With Docetaxel and Capecitabine (DC)

NCT00156312•University of Michigan Rogel Cancer Center

View on ClinicalTrials.gov

Summary

The purpose of this study is to determine whether the combination of the drugs docetaxel and capecitabine is effective in treating breast cancer patients.

Detailed Description

Some chemotherapy drugs are thought to work in synergy, meaning they work better in combination, rather than singly because one drug may cause changes in the tumor that will make the other drug more effective. The drugs docetaxel and capecitabine may work in synergy, based on laboratory studies in tumors. These laboratory studies show that docetaxel increases the levels of a critical enzyme, called thymidine phosphorylase (TP), which is necessary to activate the capecitabine. This study will use this promising chemotherapy combination in patients with breast cancer. Before, during, and after chemotherapy, the participants' breast tumors will be examined to see if TP increases, as predicted by the laboratory studies. The study will also look at other factors in tumors and blood that may be able to predict how effective the chemotherapy will be for each individual, so that in the future we may better select the best chemotherapy for an individual's cancer.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•All patients must have a primary measurable invasive breast cancer with the primary tumor intact (T1, 2, 3, or 4, any N, M0). The clinical stage must meet one of the following criteria:
•1. Size ≥ 2 cm on mammography, ultrasound, or PE
•2. OR ≥ 1 cm and ER negative, and amenable to research biopsy.
•3. OR \<1 cm and documented intact axillary metastasis amenable to serial research CORE biopsies.
•Histologic diagnosis of at least one site of invasive cancer must be by core needle biopsy or incisional biopsy. Immunohistochemical staining for estrogen and progesterone receptors, and HER-2 neu receptor should be obtained on the initial diagnostic sample.
•Patients must have had mammography performed at the University of Michigan, OR outside film review prior to enrollment.
•Patients must have clinical ultrasound performed at the University of Michigan prior to enrollment.
•All patients are required to sign an informed consent regarding the experimental nature of this therapy, including the research biopsies, in accordance with the University of Michigan Institutional Review Board standards.
•Patients must have ECOG Performance status of 0-1.
•This study is limited to women only.
+2 more criteria

Exclusion Criteria

•Breast tumors that are not measurable by any of the modalities, including physical examination, mammography, or ultrasound.
•Tumors diagnosed by excisional biopsy, or incisional biopsy that does not leave measurable disease by physical examination, mammography, or ultrasound.
•Age less than 18 years.
•Granulocyte count of \<1500/mm3, hemoglobin \<8.0 g/dl platelet count of \<100,000/mm3.
•Grade greater than or equal to 2 peripheral neuropathy.
•Hepatic
•1. Total Bilirubin \> ULN
•2. AST and ALT and Alkaline Phosphatase must be within the range allowing for eligibility, as per protocol.
•Patients who are pregnant or nursing will not be eligible for this protocol.
•Patients with a history of severe hypersensitivity reaction to drugs formulated with polysorbate 80.
+9 more criteria

Locations (1)

University of Michigan Cancer Center

Ann Arbor, Michigan, United States

Key Dates

Start Date

July 1, 2003

Primary Completion Date

May 1, 2005

Completion Date

February 1, 2007

Last Updated

February 7, 2012

Enrollment

ESTIMATED participants

Conditions

Breast Cancer

Interventions

Docetaxel

DRUG

Capecitabine

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 7, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Evaluation of Tumor Factors in Breast Cancer Treated With Docetaxel and Capecitabine

Inclusion Criteria

Exclusion Criteria

Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy

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