Actively Recruiting
Neoadjuvant Weekly Paclitaxel and Biomarkers of Therapy Response
Led by University of Wisconsin, Madison · Updated on 2026-01-16
50
Participants Needed
2
Research Sites
481 weeks
Total Duration
On this page
Sponsors
U
University of Wisconsin, Madison
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Neoadjuvant Weekly Paclitaxel and Biomarkers of Therapy Response
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women with pathologically demonstrated breast cancer
- Candidates for neoadjuvant paclitaxel chemotherapy as determined by their treating oncologist without concurrent investigational or commercial cancer therapies
- No metastatic disease found during staging work-up according to institutional guidelines
- Availability of a formalin-fixed paraffin embedded tumor block or at least 8 unstained slides from a previous biopsy of the primary tumor or lymph node
- Primary tumor or lymph node must be accessible for biopsy by surgery or radiology
- Primary tumor must be measurable by imaging before treatment and after 4 cycles of paclitaxel prior to surgery using ultrasound, CT, mammography, or preferably MRI
- No prior systemic chemotherapy for current breast cancer, except non-therapeutic studies using non-FDA approved agents
- Adequate organ and marrow function as determined by the treating oncologist
- Willingness to undergo additional biopsy of breast tumor or lymph node
- Ability and willingness to sign informed consent
- Women of childbearing potential must agree to use effective contraception during the study
You will not qualify if you...
- History of allergic reactions to paclitaxel or drugs with similar chemical or biological components including Cremophor(R) EL
- Known HIV infection due to risks of immunosuppression and infections during chemotherapy
- Use of non-aspirin blood thinners (e.g., Coumadin, heparins, clopidogrel) or diagnosed bleeding disorders
- Uncontrolled serious illnesses such as severe infections, symptomatic heart failure, unstable angina, arrhythmia, other cancers requiring therapy, or psychiatric/social conditions limiting study compliance
- Pregnant or breastfeeding women due to risks of paclitaxel to fetus and infants
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
University of Iowa Health Care/Holden Comprehensive Cancer Center
Iowa City, Iowa, United States, 52242
Not Yet Recruiting
2
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, United States, 53792
Actively Recruiting
Research Team
C
Cancer Connect
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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