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NCT03911973 · ClinicalTrials.gov registry record · Phase 1

Gedatolisib Plus Talazoparib in Advanced Triple Negative or BRCA1/2 Positive, HER2 Negative Breast Cancers

A Phase 1 study of TNBC - Triple-Negative Breast Cancer, sponsored by Kari Wisinski.

Active
Registry status
Phase 1
Development phase
37
Enrollment target
5
Study locations

NCT03911973: Active Phase 1 study of TNBC - Triple-Negative Breast Cancer, sponsored by Kari Wisinski.

NCT03911973 is a Phase 1 study of TNBC - Triple-Negative Breast Cancer that is active but no longer recruiting, run by Kari Wisinski. The registered enrollment target is 37 participants, below the 480-participant average among 22 other TNBC - Triple-Negative Breast Cancer trials with a reported enrollment target (92% lower). The trial reports 5 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03911973, a Phase 1 study of TNBC - Triple-Negative Breast Cancer, is active but no longer recruiting, sponsored by Kari Wisinski.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
37 participants
Enrollment target
5
Study locations

Study Summary

This study is designed to determine the RP2D of gedatolisib in combination with talazoparib and to evaluate the efficacy of this combination in advanced HER2 negative breast cancer that is triple negative or BRCA1/2 positive (deficient).

Primary Outcome

Determine the recommended Phase 2 dose (RP2D) of talazoparib in combination with gedatolisib in patients with advanced human epidermal growth factor receptor 2 (HER2) negative (triple negative or BRCA1/2 deficient) breast cancer.

Interventions

  • DRUG Talazoparib
  • DRUG Gedatolisib

Study Locations (5)

Illinois

  • Northwestern University Feinberg School of Medicine - Chicago
  • University of Illinois Cancer Center - Chicago

Indiana

  • Indiana University Melvin and Bren Simon Comprehensive Cancer Center - Indianapolis

Iowa

  • University of Iowa Hospital and Clinics - Iowa City

Wisconsin

  • University of Wisconsin - Madison

Trial Details

FieldValue
Enrollment Target 37 participants
Start Date 2019-04-17
Est. Completion 2024-07
Phase Phase 1
Kari Wisinski

2 total trials

What the registry record for NCT03911973 still lists

NCT03911973 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 480-participant average among 22 other TNBC - Triple-Negative Breast Cancer trials with a reported enrollment target (92% lower).

The record links to 1 condition, with TNBC - Triple-Negative Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Talazoparib is the first listed.

NCT03911973 lists 5 locations in 4 states (Illinois, Indiana, Iowa).

Frequently Asked Questions

What is clinical trial NCT03911973 about?

NCT03911973 is a clinical study titled "Gedatolisib Plus Talazoparib in Advanced Triple Negative or BRCA1/2 Positive, HER2 Negative Breast Cancers". This study is designed to determine the RP2D of gedatolisib in combination with talazoparib and to evaluate the efficacy of this combination in advanced HER2 negative breast cancer that is triple negative or BRCA1/2 positive (deficient).

What is the current status of trial NCT03911973?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 37 participants. The study started on 2019-04-17. Estimated completion is 2024-07.

What conditions does trial NCT03911973 study?

This clinical trial studies the following conditions: TNBC - Triple-Negative Breast Cancer.

What interventions are being tested in trial NCT03911973?

The interventions under investigation include: Talazoparib (DRUG), Gedatolisib (DRUG).

Who is sponsoring clinical trial NCT03911973?

This trial is sponsored by Kari Wisinski, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03911973 being conducted?

This trial has 5 study locations across Illinois, Indiana, Iowa, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for TNBC - Triple-Negative Breast Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03911973's enrollment target sits among peer trials

37 15th of 22 higher than 8 of 22 other TNBC - Triple-Negative Breast Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other TNBC - Triple-Negative Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03911973, the US trial registry maintained by the National Library of Medicine. NCT03911973 (small enrollment · multi site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.