- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01263613
Feasibility Study of Biomarkers of Response to Neoadjuvant Paclitaxel in Locally Advanced Breast Cancer
November 15, 2019 updated by: University of Wisconsin, Madison
The purpose of this study is to determine if the investigators are able to locate and measure certain characteristics in breast cancer tumors that have been treated with paclitaxel that may correlate to how well the cancer will respond to the chemotherapy.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
6
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Wisconsin
-
Madison, Wisconsin, United States, 53792
- University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Women with pathologically demonstrated breast cancer.
- Patients must be candidates for neoadjuvant paclitaxel chemotherapy by their treating oncologist. Generally this would include:
- Women with node-positive breast cancer based on ultrasound-guided axillary node biopsy, regardless of hormone or HER2 receptor status.
- Women with greater than 1 cm breast cancer on imaging (mammogram, ultrasound, breast MRI) who are HER2+ or triple negative (ER-PR-HER2-).
- Women who are candidates for standard paclitaxel chemotherapy from treating oncologist for any other reason.
- Patients must not have metastatic disease on staging work-up with chest imaging, CBC, and liver function studies.
- A formalin-fixed paraffin embedded tumor block (preferred) or unstained slides must be available from a prior biopsy of the primary tumor. A minimum of 5 unstained slides must be available.
- The primary tumor must be readily able to be biopsied by palpation.
- The primary tumor must be measurable by an imaging modality prior to treatment. This imaging modality is to be repeated after completion of 4 cycles of paclitaxel and prior to surgery. Such imaging modalities may include ultrasound, CT, mammography, or MRI. MRI will be the preferred imaging modality.
- Subjects may not have had prior systemic chemotherapy or targeted therapy regimens administered for treatment of their current breast cancer.
- Age >18 years. Breast cancer is rare in women < 18 years old. The safety of paclitaxel in pediatric population with breast cancer has not been established, therefore these patients are ineligible.
- Patients must have adequate organ and marrow function
- Patient must be willing to undergo additional biopsy of breast tumor.
- Patient must have the ability and willingness to sign a written informed consent document.
Exclusion Criteria:
- Patients who have had systemic chemotherapies, targeted therapies or radiotherapy for any cancer within 5 years prior to entering the study.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to paclitaxel including to other drugs formulated in Cremophor(R) EL (polyoxyethylated castor oil).
- Patients with known HIV due to concern that chemotherapy may cause further immunosuppression and potential infectious complications.
- Patients on non-aspirin anti-coagulation (Coumadin, heparins, or clopidogrel) or with documented bleeding disorders will be excluded due to risk of bleeding with biopsy.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active severe infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, other malignancies requiring therapy or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant women are excluded from this study because paclitaxel is a pregnancy category D drug and may cause deleterious effects to the fetus. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with paclitaxel, breastfeeding should be discontinued if the mother is enrolled in the trial.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Biopsy
biopsy
|
tumor biopsy and blood draw during and after chemotherapy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Determine feasibility of measuring biomarkers in breast tumors 20 hours after administration of the first dose of paclitaxel chemotherapy.
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Measure drug levels in breast tumors 20 hours after administration of paclitaxel
Time Frame: 1 year
|
1 year
|
Determine feasibility of correlating drug levels with biomarkers including mitotic index, aneuploidy, and Ki67
Time Frame: 1 year
|
1 year
|
Determine feasibility of correlating pathologic response and clinical response with biomarkers including mitotic index, aneuploidy, and Ki67.
Time Frame: 1 year
|
1 year
|
Determine the feasibility of obtaining circulating tumor cells (CTCs) for analysis including evaluation for mitosis.
Time Frame: 1 year
|
1 year
|
Compare biomarkers from tissue samples obtained 20 hours after administration of paclitaxel with tissue obtained at the time of surgery.
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Mark E Burkard, MD, PhD, University of Wisconsin Paul P. Carbone Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2010
Primary Completion (Actual)
June 1, 2013
Study Completion (Actual)
June 1, 2013
Study Registration Dates
First Submitted
December 16, 2010
First Submitted That Met QC Criteria
December 17, 2010
First Posted (Estimate)
December 20, 2010
Study Record Updates
Last Update Posted (Actual)
November 19, 2019
Last Update Submitted That Met QC Criteria
November 15, 2019
Last Verified
April 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OS10103
- P30CA014520 (U.S. NIH Grant/Contract)
- A534260 (Other Identifier: UW Madison)
- SMPH\MEDICINE\HEM-ONC (Other Identifier: UW Madison)
- 2010-0357 (Other Identifier: Institutional Review Board)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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