NCT03096418

Neoadjuvant Weekly Paclitaxel and Biomarkers of Therapy Response

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Primary Objectives * To test if cancers with high chromosomal instability (CIN) respond to paclitaxel better than low CIN cancers. Secondary Objectives * To identify patient-specific differences in tumor levels and distribution of paclitaxel at 20 hours after first dose and patient-specific differences in peripheral non-tumor tissue (skin or plasma) paclitaxel levels 20 ± 4 hours after first dose. * To determine if paclitaxel levels are higher at 20h after the 3rd dose than after the first dose, and if levels are higher at 20h after the 10th, 11th, or 12th dose than the 1st and 3rd dose. * Compare pre-existing versus post-treatment antimitotic effects at 20h after the 1st dose, 20h after the 3rd dose, and 20h after the 10th, 11th, or 12th dose. * Correlate drug levels and distribution with biomarkers including mitotic index, aneuploidy, chromosomal instability, and Ki67. * Correlate pathologic response and clinical response with biomarkers including mitotic index, aneuploidy, CIN and Ki67. * To test if CIN increases in patient tumors in response to paclitaxel and to evaluate the feasibility of these measurements by genomic analysis. Initial Actual Primary and Study Completion Date registered as 8/16/2022 with 24 participants enrolled. Per a Protocol Amendment dated 5/7/24, this study will re-open to enroll up to 50 participants. NCI funding and data sharing information added.

Conditions

• Breast Neoplasm Female

Interventions

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

Timeline

• Start date: 2017-03-13
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2017-03-30
• Last updated: 2026-01-16
• Results posted: 2023-10-13

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study