Study on Weekly Paclitaxel and Therapy Response Markers for Breast Cancer

Sponsor: University of Wisconsin, Madison

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03096418

Provider View

This clinical trial is exploring how the chemotherapy drug paclitaxel affects breast cancer tumors, especially those with high chromosomal instability, and whether it can be more effective in shrinking these tumors before surgery.

Patient Parameters

Program Overview

The study aims to find out if the chemotherapy drug paclitaxel can effectively target breast cancer tumors with high chromosomal instability (CIN), which means the cancer cells have a lot of genetic changes. Participants will receive paclitaxel treatments on an outpatient basis, with infusions given on days 1, 8, and 15 of a 21-day cycle, continuing for four cycles before surgery. Researchers will measure paclitaxel levels in the body and observe how the tumors respond to the treatment.

Description

The main goal of this study is to see if breast cancers with high chromosomal instability (CIN) respond better to the chemotherapy drug paclitaxel compared to those with low CIN. Researchers will also look at how paclitaxel is distributed in the body and how it affects both tumor and non-tumor tissues.

Secondary goals include:

  • Measuring paclitaxel levels in the body at different times after treatment.
  • Comparing the effects of paclitaxel on cancer cells before and after treatment.
  • Analyzing how paclitaxel levels relate to various biological markers in the tumor.
  • Evaluating if CIN increases in tumors after paclitaxel treatment using genetic analysis.

The study initially enrolled 24 participants and plans to reopen to include up to 50 participants, with funding and data sharing supported by the National Cancer Institute (NCI).

Eligibility Criteria

Inclusion Criteria

  • Women diagnosed with breast cancer.
  • Eligible for paclitaxel chemotherapy before surgery, as determined by their doctor.
  • No evidence of cancer spread to other parts of the body.
  • Availability of a tumor sample from a previous biopsy.
  • Tumor must be measurable by imaging tests like ultrasound, CT, mammography, or MRI before and after treatment.
  • No prior chemotherapy for the current breast cancer, except for non-therapeutic studies.
  • Adequate organ and bone marrow function.
  • Willingness to undergo additional tumor biopsy.
  • Ability to sign informed consent.
  • Women of childbearing potential must agree to use effective birth control during the study.

Exclusion Criteria

  • Allergic reactions to paclitaxel or similar drugs.
  • Known HIV infection due to potential immune system effects.
  • Use of certain blood thinners or bleeding disorders due to biopsy risks.
  • Uncontrolled illnesses like severe infections, heart problems, or other cancers needing treatment.
  • Pregnant or breastfeeding women due to potential risks to the baby.

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