Neoadjuvant Weekly Paclitaxel and Biomarkers of Therapy Response
ConditionBreast Neoplasm Female
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Wisconsin, Madison
About this trial
The hypothesis of this study is that paclitaxel levels increase chromosomal instability (CIN) in tumors and this is lethal to tumors that have pre-existing CIN. Treatment will be administered on an outpatient basis. Paclitaxel will be initiated as standard infusions on days 1, 8, and 15 of a 21-day cycle. Participants will continue with paclitaxel for cycles 2-4 prior to surgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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 (preferred) or lymph node. A minimum of 8 slides must be available.
Disqualifiers
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 as determined by treatment physician.
Trial design
Design model
Single group
Treatments tested in this trial
Paclitaxel
DrugPaclitaxel is an FDA approved medication for treatment of curable breast cancer and is available by prescription at pharmacies throughout the United States.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Weekly PaclitaxelExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Response to Paclitaxel
To test if high cancers with high chromosomal instability (CIN) respond to paclitaxel better than low CIN cancers. Response determined by the percent decrease in linear measurement of tumor size on the greatest dimension per RECIST-like criteria
Time frame
Up to 3 monthsSecondary outcomes
1
Tumor Level Difference of Paclitaxel
Identify patient-specific differences in tumor levels of paclitaxel at 20 hours after first dose. This is measured by high-performance liquid chromatography of tumor and plasma samples and comparing variability between patients with descriptive statistics.
Time frame
Up to 1 day2
Non-Tumor Level Difference of Paclitaxel
Identify patient-specific differences in non-tumor (plasma) levels of paclitaxel at 20 hours after first dose. This is measured by high-performance liquid chromatography of tumor and plasma samples and comparing variability between patients with descriptive statistics.
Time frame
Up to 1 day3
Paclitaxel Levels
Paclitaxel levels at the first dose, 20 hours after the 3rd dose, and 20 hours after the 12th dose. This is measured by high-performance liquid chromatography of tumor and plasma samples and comparing difference at two time points within the same patient with paired statistics.
Time frame
Up to 79 days4
Antimitotic Effects
Compare pre-existing versus post-treatment antimitotic effects at 20 hours after the 1st dose, 20 hours after the 3rd dose, and 20 hours after the 12th dose. This is measured by tissue analysis of tumor samples with phospho-histone H3 and stains for spindle morphology to quantify mitotic index and mitotic characteristics at two time points using paired statistical analysis.
Time frame
Up to 79 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Wisconsin, Madison
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov