Neoadjuvant Weekly Paclitaxel and Biomarkers of Therapy Response

Launched by UNIVERSITY OF WISCONSIN, MADISON · Mar 23, 2017

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a chemotherapy drug called paclitaxel on women with breast cancer. The researchers believe that paclitaxel can increase a condition known as chromosomal instability (CIN) in tumors, which might make them more vulnerable to treatment. The trial involves outpatient visits where participants will receive paclitaxel infusions on specific days over a 21-day cycle, continuing for a total of four cycles before surgery takes place. The goal is to see how effective this treatment is at shrinking the tumors before surgery.

To be eligible for the trial, participants need to be women diagnosed with breast cancer who have not received prior chemotherapy for this condition. They should have a measurable tumor and be willing to undergo additional biopsies. It’s important that participants do not have serious health issues that could interfere with the study and that they are not pregnant or breastfeeding. During the study, participants will have regular imaging tests to monitor the size of their tumors and assess how well the treatment is working. Overall, this study aims to provide valuable insights into how paclitaxel can help women with breast cancer before surgery.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Women with pathologically demonstrated breast cancer
• • Patients must be candidates for neoadjuvant paclitaxel chemotherapy by their treating oncologist. No other investigational or commercial therapeutic agents may be given concurrently with the paclitaxel.
• • Patients must not have metastatic disease on staging work-up per institutional guidelines.
• • A formalin-fixed paraffin embedded tumor block (preferred) or unstained slides must be available from a prior biopsy of the primary tumor or lymph node. A minimum of 8 slides must be available.
• • The primary tumor or lymph node must be readily biopsied by surgery or radiology teams.
• • 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 if available because it has the highest accuracy and positive predictive value for predicting pathologic complete response.All imaging will be performed per standard of care at the discretion of the treating physicians.
• • Subjects may not have had prior systemic chemotherapy regimens administered for treatment of their current breast cancer. However, studies (window studies, for example) that are deemed non-therapeutic, including those that utilize agents that are not FDA approved for the treatment of the patient's current breast cancer, are permitted.
• • Patients must have adequate organ and marrow function as determined by the treating oncologist.
• • Patient must be willing to undergo additional biopsy of breast tumor or lymph node.
• • Patient must have the ability and willingness to sign a written informed consent document.
• • Women of childbearing potential (per UWCCC policy definition) must agree to use effective contraception as discussed with treating oncologist for the duration of the study.
• Exclusion Criteria:
• • 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.