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

18 Years
Not Enrolling
Breast Cancer

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Trial Information

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

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.

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.

- Women of childbearing potential must have a documented negative serum HCG within 7
days prior to treatment. Postmenopausal women must have been amenorrheic for at least
12 months to be considered of non-childbearing potential.

- Women of childbearing potential must be willing to consent to using effective
contraception while on treatment and for at least 3 months thereafter.

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.

- Prior unanticipated severe reaction to fluoropyrimidine therapy, or known sensitivity
to 5-fluorouracil or known DPD deficiency.

- Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic
coronary artery disease and cardiac arrhythmias not well controlled with medication)
or myocardial infarction within the last 12 months

- Any medical condition which in the opinion of the investigator puts the patient at
undo risk of potentially serious complications while on this therapy.

- Major surgery within 4 weeks of the start of study treatment, without complete

- Lack of physical integrity of the upper gastrointestinal tract or malabsorption

- Requirement for full dose coumadin therapy (not port prophylaxis), or a known,
existing uncontrolled coagulopathy.

- Impaired renal function (estimated creatinine clearance <45ml/min as calculated with
Cockcroft-Gault equation. There will be a mandated dose reduction of capecitabine for
creatinine clearance < 50 ml/min to dose level -1.

- Patients must not have received any prior chemotherapy or radiation therapy for their
current breast cancer. Patients who received less than 4 weeks of hormonal therapy
for the treatment of the current breast cancer may be included if they agree to stop
the hormonal therapy during chemotherapy. Patients who received tamoxifen or other
agents for prevention of breast cancer may be included.

- Patients with active systemic malignancy in the past year.

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

specific key measurements

Outcome Time Frame:

refer to protocol

Safety Issue:


Principal Investigator

Anne Schott, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Michigan


United States: Institutional Review Board

Study ID:

UMCC 2003.045



Start Date:

July 2003

Completion Date:

February 2007

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms



University of Michigan Cancer Center Ann Arbor, Michigan  48109