Breast CancerNCT00156312
Evaluation of Tumor Factors in Breast Cancer Treated With Docetaxel and Capecitabine
A study testing Docetaxel and Capecitabine in people with Breast Cancer, run by University of Michigan Rogel Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Docetaxel and Capecitabine
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2003to Feb 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- Size ≥ 2 cm on mammography, ultrasound, or PE
- OR ≥ 1 cm and ER negative, and amenable to research biopsy.
- 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.
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- 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.
Who cannot join
- 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
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- Total Bilirubin > ULN
- 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 recovery.
- Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Cancer Center
Ann Arbor, Michigan, 48109
About this study
Official title: Evaluation of Thymidine Phosphorylase and Other Predictive/Prognostic Factors in Primary Breast Cancer Treated With Docetaxel and Capecitabine (DC)
The purpose of this study is to determine whether the combination of the drugs docetaxel and capecitabine is effective in treating breast cancer patients.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Docetaxel, Capecitabine
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DocetaxelDrug
CapecitabineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
specific key measurements
Measured: refer to protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startJul 2003
- Primary completionMay 2005
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of Michigan Rogel Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Investigators
- Anne Schott, M.D., Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00156312
- Sponsor's protocol ID
- UMCC 2003.045
- Status last verified
- Feb 2012
- First submitted
- 8 Sep 2005
- Last updated
- 7 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Thymidine Phosphorylase and Other Predictive/Prognostic Factors in Primary Breast Cancer Treated With Docetaxel and Capecitabine (DC)
- ClinicalTrials.gov ID
- NCT00156312
- Acronym / sponsor ID
- UMCC 2003.045
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Study start
- Jul 2003
- Primary completion
- May 2005 (actual)
- Study completion
- Feb 2007 (actual)
- First posted
- 12 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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:
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Docetaxel | Drug | – |
| Capecitabine | Drug | – |
Primary outcome
specific key measurements
Time frame: refer to protocol
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Schott, M.D. principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Docetaxel and Capecitabine in people with Breast Cancer, run by University of Michigan Rogel Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
specific key measurements (time frame: refer to protocol). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2012; AzTrials last refreshed its copy on 8 Nov 2026.