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Weekly Paclitaxel and Biomarkers for Breast Cancer

This study is looking at how well the chemotherapy drug paclitaxel works for women with breast cancer that has not spread (non-metastatic). Researchers want to see if tumors with high chromosomal instability (CIN), which means changes in their genetic material, respond better to paclitaxel. You would receive paclitaxel as standard infusions over four cycles before surgery. The study also aims to understand how paclitaxel levels in the body relate to how tumors respond. This study is currently re-opening to enroll up to 50 participants.

Study design
This is an interventional study with a planned enrollment of 50 participants. It is not specified if it is randomized or blinded.
What's involved
You would receive paclitaxel infusions on days 1, 8, and 15 of a 21-day cycle for cycles 2-4 prior to surgery. Blood and tissue samples would be taken to measure paclitaxel levels and tumor changes.
Compensation
Not stated in the trial record.
Follow-up
Response to paclitaxel will be measured up to 3 months after treatment.

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NCT03096418

Neoadjuvant Weekly Paclitaxel and Biomarkers of Therapy Response

Recruiting
PHASE4Ages 18+InterventionalTreatment
University of Wisconsin, Madison
~50 participants
Updated 2026-06-16 on ClinicalTrials.gov
What's tested:Paclitaxel

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Response to Paclitaxel
Measured over Up to 3 months

Conditions

Breast Neoplasm Female

Explore related trials

Breast Carcinoma

Where it's being run

2 sites across 2 states
Iowa1
Wisconsin1

Study leadership

  • Marina Sharifi, MD, PhD · PRINCIPAL_INVESTIGATOR · University of Wisconsin, Madison

Who to contact

Cancer Connect
[email protected]
800-622-8922
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.
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 institutional policy) must agree to use effective contraception as discussed with treating oncologist for the duration of the study.

Exclusion

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.
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.

What this trial measures

  • Response to PaclitaxelUp to 3 months

    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