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Completed Phase 3 Interventional

Trilaciclib, a CDK 4/6 Inhibitor, in Patients Receiving Gemcitabine and Carboplatin for Metastatic Triple-Negative Breast Cancer (TNBC)

ClinicalTrials.gov ID: NCT04799249

Public ClinicalTrials.gov record NCT04799249. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 22, 2026, 10:48 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 3, Randomized, Double-Blind Study of Trilaciclib or Placebo in Patients Receiving First- or Second-Line Gemcitabine and Carboplatin Chemotherapy for Locally Advanced Unresectable or Metastatic Triple-Negative Breast Cancer (PRESERVE 2)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of trilaciclib versus placebo administered prior to gemcitabine and carboplatin in patients receiving first- or second-line treatment for locally advanced unresectable/metastatic TNBC.

Study identification

NCT ID
NCT04799249
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
G1 Therapeutics, Inc.
Industry
Enrollment
194 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 14, 2021 (Actual)
Primary completion
May 24, 2024 (Actual)
Completion
May 24, 2024 (Actual)
Last update posted
Aug 1, 2024

2021 – 2024

United States locations

U.S. sites
16
U.S. states
11
U.S. cities
16
Facility City State ZIP Site status
Banner M.D. Anderson Cancer Center Gilbert Arizona 85234 —
Washington Cancer Institute at MedStar Washington Hospital Center - Oncology Research Washington D.C. District of Columbia 20010 —
Florida Cancer Specialists - North (SCRI) St. Petersburg Florida 33705 —
Moffitt Cancer Center Tampa Florida 33612 —
Maryland Oncology Hematology, P.A. Clinton Maryland 20735 —
Saint Luke's Cancer Specialists Kansas City Missouri 64111 —
Comprehensive Cancer Genetics of Nevada Las Vegas Nevada 89128 —
Duke Cancer Center Durham North Carolina 27710 —
UPC Pinnacle Health Cancer Institute Pittsburgh Pennsylvania 15232 —
Tennessee Oncology Chattanooga Chattanooga Tennessee 37404 —
Baptist Cancer Cancer - Oncology Memphis Tennessee 38120 —
Tennessee Oncology (SCRI) Nashville Tennessee 37203 —
Texas Oncology- Austin Central Austin Texas 78731 —
Texas Oncology - Baylor Charles A. Sammons Cancer Center Dallas Texas 75246 —
Texas Oncology P.A. Tyler Texas 75702 —
Virginia Oncology Associates Norfolk Virginia 23502 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 55 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04799249, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 1, 2024 · Synced Oct 22, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT04799249 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →