Feasibility Study of Biomarkers of Response to Neoadjuvant Paclitaxel in Locally Advanced Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01263613
Recruitment Status : Completed
First Posted : December 20, 2010
Last Update Posted : April 8, 2014
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Procedure: tumor biopsy and blood draw Early Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Feasibility Study of Biomarkers of Response to Neoadjuvant Paclitaxel in Locally Advanced Breast Cancer
Study Start Date : December 2010
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel
U.S. FDA Resources

Arm Intervention/treatment
Procedure: tumor biopsy and blood draw
tumor biopsy and blood draw during and after chemotherapy

Primary Outcome Measures :
  1. Determine feasibility of measuring biomarkers in breast tumors 20 hours after administration of the first dose of paclitaxel chemotherapy. [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Measure drug levels in breast tumors 20 hours after administration of paclitaxel [ Time Frame: 1 year ]
  2. Determine feasibility of correlating drug levels with biomarkers including mitotic index, aneuploidy, and Ki67 [ Time Frame: 1 year ]
  3. Determine feasibility of correlating pathologic response and clinical response with biomarkers including mitotic index, aneuploidy, and Ki67. [ Time Frame: 1 year ]
  4. Determine the feasibility of obtaining circulating tumor cells (CTCs) for analysis including evaluation for mitosis. [ Time Frame: 1 year ]
  5. Compare biomarkers from tissue samples obtained 20 hours after administration of paclitaxel with tissue obtained at the time of surgery. [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01263613

United States, Wisconsin
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Principal Investigator: Mark E Burkard, MD, PhD University of Wisconsin Paul P. Carbone Cancer Center

Responsible Party: University of Wisconsin, Madison Identifier: NCT01263613     History of Changes
Other Study ID Numbers: OS10103
First Posted: December 20, 2010    Key Record Dates
Last Update Posted: April 8, 2014
Last Verified: April 2014

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action