Chromosomal instability sensitizes patient breast tumors to multipolar divisions induced by paclitaxel.
Christina M Scribano, Jun Wan, Karla Esbona...
https://pubmed.ncbi.nlm.nih.gov/34516829Actively Recruiting
Phase 4
Age: 18Years +
FEMALE
ID03096418
Neoadjuvant Weekly Paclitaxel and Biomarkers of Therapy Response for Breast Cancer
Led by University of Wisconsin, Madison · Updated on 2026-01-16
50
Participants Needed
2
Research Sites
N/A
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
Researchers are studying women with breast cancer to see if tumors with high chromosomal instability (CIN) respond better to the chemotherapy drug paclitaxel compared to tumors with low CIN. The study aims to understand how paclitaxel levels in tumors relate to treatment response and to identify biomarkers that may predict effectiveness. This research is supported by the University of Wisconsin, Madison, and focuses on measuring cancer response and drug effects over several months. Participants receive paclitaxel as an outpatient treatment, given by infusion at a dose of 80 mg/m2 on days 1, 8, and 15 of each 21-day cycle. Treatment continues for four cycles before surgery. Researchers will measure paclitaxel levels in tumor and non-tumor tissue at various times after doses and evaluate the drug's impact on tumor cells through genomic analysis and biomarkers such as mitotic index, aneuploidy, and Ki67. During the study, participants will have imaging tests like ultrasound, CT, mammography, or MRI to measure tumor size before and after treatment. Additional tumor biopsies will be taken to analyze drug levels and chromosomal changes. Researchers will monitor treatment response and safety for up to three months, collecting data on tumor biomarkers and clinical outcomes. The total participation time includes the treatment period and follow-up before surgery.
CONDITIONS
Brief Title
Neoadjuvant Weekly Paclitaxel and Biomarkers of Therapy Response
Who Can Participate
Age: 18Years +
FEMALE
Eligibility Criteria
You may qualify if you...
- Women with pathologically confirmed breast cancer
- Candidates for neoadjuvant paclitaxel chemotherapy as determined by their oncologist
- No metastatic disease based on staging work-up
- Availability of tumor biopsy samples with a minimum of 8 slides
- Primary tumor or lymph node must be accessible for biopsy
- Tumor measurable by imaging before treatment and after 4 cycles of paclitaxel
- No prior systemic chemotherapy for current breast cancer
- Adequate organ and marrow function
- Willingness to undergo additional tumor or lymph node biopsy
- Ability and willingness to provide 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 similar compounds including Cremophor EL
- Known HIV infection
- Use of non-aspirin anticoagulants or bleeding disorders
- Uncontrolled illnesses such as severe infections, heart failure, unstable angina, arrhythmia, other cancers needing therapy, or psychiatric/social conditions limiting compliance
- Pregnancy or breastfeeding women are excluded due to paclitaxel risks to fetus and infant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to approximately 3 months
Participants receive weekly paclitaxel chemotherapy infusions over multiple cycles prior to surgery.
Weekly visits for up to 12 weeks
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
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Research Team
C
Cancer Connect
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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