Recruiting

Paclitaxel

Sponsor:

University of Wisconsin, Madison

Code:

NCT03096418

Conditions

Breast Neoplasm Female

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Paclitaxel

Study Details

Brief summary:

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

Breast Neoplasm Female

Study ID

NCT03096418

Start date

Mar 13, 2017

Status verified date

Jun, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Weekly Paclitaxel

Paclitaxel 80 mg/m2 will be initiated as standard infusion on days 1, 8, 15 of a 21-day cycle.

Participants will continue with paclitaxel 80 mg/m2 for cycles 2-4 prior to surgery.

Interventions

Paclitaxel

Paclitaxel is an FDA approved medication for treatment of curable breast cancer and is available by prescription at pharmacies throughout the United States.

Primary outcome measure

  • Response to Paclitaxel [ Time Frame: Up to 3 months ]

Central Contacts and Locations

Central contacts

Cancer Connect

800-622-8922clinicaltrials@cancer.wisc.edu

Locations

University of Iowa Health Care/Holden Comprehensive Cancer Center

Recruiting

Iowa City, Iowa, United States, 52242

Principal Investigator:

Mark Burkard, MD, PhD

University of Wisconsin Carbone Cancer Center

Recruiting

Madison, Wisconsin, United States, 53792

Contacts

Cancer Connect

800-622-8922clinicaltrials@cancer.wisc.edu

More Information

Sponsor

University of Wisconsin, Madison

Last update posted

Jun 16, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Wisconsin, Madison on 2026-06-16.