Study of Weekly Paclitaxel Treatment and Biomarkers in Women With Breast Cancer Before Surgery

What this Trial Is About

Researchers are studying breast cancer in women to see if tumors with high chromosomal instability CIN respond better to the chemotherapy drug paclitaxel compared to tumors with low CIN. This study also aims to understand how paclitaxel levels vary in tumors and non-tumor tissues, and how these levels relate to various biomarkers and treatment responses. The study is supported by the University of Wisconsin, Madison, and is designed as a Phase 4 interventional trial. Participants will receive paclitaxel infusions at a dose of 80 mgm2 on days 1, 8, and 15 of a 21-day cycle, continuing for up to four cycles before surgery. Treatment is given on an outpatient basis. Researchers will measure paclitaxel levels and antimitotic effects at multiple time points after dosing, including after the first, third, and later doses. The study also involves genomic analyses to evaluate the changes in CIN levels in response to treatment. During the study, participants will undergo imaging of their primary tumor before treatment, after the four paclitaxel cycles, and prior to surgery using modalities such as MRI, ultrasound, CT, or mammography. Biopsies of the tumor or lymph nodes will be taken for analysis. Researchers will monitor biomarkers like mitotic index, aneuploidy, Ki67, and chromosomal instability. The main outcome measured is the tumors response to paclitaxel within about three months. Safety and treatment effects will be closely followed throughout the study period, which lasts until June 2027.

Neoadjuvant Weekly Paclitaxel and Biomarkers of Therapy Response