RecruitingPhase 4NCT03096418

Neoadjuvant Weekly Paclitaxel and Biomarkers of Therapy Response

Sponsor

University of Wisconsin, Madison

Enrollment

50 participants

Start Date

Mar 13, 2017

Study Type

INTERVENTIONAL

Conditions

Breast Neoplasm Female

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at biological markers (signals in the body) that may predict how well breast cancer responds to a chemotherapy drug called paclitaxel, given before surgery to shrink the tumor. **You may be eligible if...** - You are a woman diagnosed with breast cancer (confirmed by biopsy) - Your doctor has recommended paclitaxel chemotherapy before surgery (called neoadjuvant chemotherapy) - Your cancer has not spread to other parts of the body - Tumor samples from a previous biopsy are available for testing (at least 8 tissue slides) - Your tumor can be measured using imaging (ultrasound, mammogram, CT, or MRI) - You have not had chemotherapy for this current breast cancer before **You may NOT be eligible if...** - Your cancer has spread to other organs (metastatic disease) - You do not have a biopsy sample available for testing - You have already received systemic chemotherapy for this breast cancer - You are receiving another experimental treatment at the same time as paclitaxel Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPaclitaxel

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