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
Qualifiers
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
Treatments tested in this trial
- Paclitaxel
Treatment groups
50 Participants
are divided into 1 treatment groupSponsors and collaborators
University of Wisconsin, Madison
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov