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Randomized Controlled Trial of Genomically Directed Therapy in Patients With Triple Negative Breast Cancer

NCT02101385 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 193

Last updated 2023-09-28

Study results available
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Summary

This study will test the theory that therapy designed for each individual's tumor will improve outcomes over standard of care in a population that needs a better standard.

Conditions

Interventions

DRUG

Genomically Directed Monotherapy

Participants randomized to Experimental Arm A will receive an FDA approved drug at standard dose for four cycles (12-16 weeks total duration, depending on cycle length). The CGTB will assign therapy to each participant individually based on biomarkers/pathways identified by DNA sequencing:

OTHER

Observation/Standard Therapy

Currently no standard therapy has proven efficacy in this patient population and thus observation alone would be considered standard of care. Additional therapy is permitted, however, if deemed appropriate by the treating physician.

Sponsors & Collaborators

  • Hoosier Cancer Research Network

    collaborator OTHER

  • Vera Bradley Foundation for Breast Cancer

    collaborator OTHER

  • Walther Cancer Institute

    collaborator OTHER

  • Indiana University

    collaborator OTHER

  • Bryan Schneider, MD

    lead OTHER

Principal Investigators

  • Bryan Schneider, M.D. · Hoosier Cancer Research Network

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-03
Primary Completion
2021-02-21
Completion
2022-09-09

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02101385 on ClinicalTrials.gov