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NCT03393741 · ClinicalTrials.gov registry record

Pharmacodynamic Biomarkers of Standard Anti-microtubule Drugs as Assessed by Early Tumor Biopsy

A clinical trial, sponsored by University of Wisconsin, Madison.

Terminated
Registry status
5
Enrollment target

NCT03393741: Clinical Trial study, sponsored by University of Wisconsin, Madison.

NCT03393741 is a clinical trial that was terminated before completion, run by University of Wisconsin, Madison. The registered enrollment target is 5 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03393741 was terminated before completion, sponsored by University of Wisconsin, Madison.

TERMINATED
Registry status
5 participants
Enrollment target

Study Summary

Eligible subjects will be assigned to study treatment arms by their treating oncologist, rather than by the study. The drug, dose, and schedule of administration will be determined by the treating physician per NCCN guidelines for standard of care chemotherapy regimens for recurrent or metastatic breast cancer. Study treatment arms include: Taxane (nab-paclitaxel or paclitaxel), Eribulin, Vinorelbine, Ixabepilone, or the control arm (non-microtubule targeted chemotherapies such as doxorubicin, carboplatin, or gemcitabine).

Primary Outcome

Advanced breast tumors safely sampled and analyzed from 35 subjects. In order to successfully test the hypothesis that chromosomal instability in part governs the effect of antimitotic therapies, advanced breast tumors samples must be collected, preserved, and analyzed at 20+/- 2 hours after chemotherapy in order to characterize the effect of the drug on the tumor. A primary question becomes is this process safe and feasible within these time constraints in our clinical setting.

Interventions

  • DRUG Chemotherapy
  • DRUG Eribulin
  • DRUG Vinorelbine
  • DRUG Taxane
  • DRUG Ixabepilone

Trial Details

FieldValue
Enrollment Target 5 participants
Start Date 2018-01-29
Est. Completion 2024-02-11
University of Wisconsin, Madison

1,039 total trials

Why NCT03393741 stopped before completion

NCT03393741 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 5 participants, a relatively small participant target.

The record links to 0 conditions, and to 5 interventions - of which Chemotherapy is the first listed.

NCT03393741 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03393741 about?

NCT03393741 is a clinical study titled "Pharmacodynamic Biomarkers of Standard Anti-microtubule Drugs as Assessed by Early Tumor Biopsy". Eligible subjects will be assigned to study treatment arms by their treating oncologist, rather than by the study. The drug, dose, and schedule of administration will be determined by the treating physician per NCCN guidelines for standard of care chemotherapy regimens for recurrent or metastatic br...

What is the current status of trial NCT03393741?

This trial is currently terminated. The enrollment target is 5 participants. The study started on 2018-01-29. Estimated completion is 2024-02-11.

What interventions are being tested in trial NCT03393741?

The interventions under investigation include: Chemotherapy (DRUG), Eribulin (DRUG), Vinorelbine (DRUG), Taxane (DRUG), Ixabepilone (DRUG).

Who is sponsoring clinical trial NCT03393741?

This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT03393741, the US trial registry maintained by the National Library of Medicine. NCT03393741 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.