Neoadjuvant Weekly Paclitaxel and Biomarkers of Therapy Response

Part of paid clinical trials in Iowa City, Iowa.

Sponsor
University of Wisconsin, Madison
Study ID
NCT03096418
Phase
PHASE4
Status
Recruiting
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Conditions

  • Breast Neoplasm Female

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Mar 13, 2017
Status verified
Dec 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of Iowa Health Care/Holden Comprehensive Cancer CenterIowa CityIowa52242
Mark Burkard, MD, PhD (PRINCIPAL_INVESTIGATOR)
University of Wisconsin Carbone Cancer CenterMadisonWisconsin53792
Cancer Connect
[email protected]
800-622-8922

Find similar trials in Iowa City, IA

By research site
University of Iowa Health Care/Holden Comprehensive Cancer Center· Iowa City, IAUniversity of Wisconsin Carbone Cancer Center· Madison, WI

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