Trilaciclib (G1T28), a CDK 4/6 Inhibitor, in Combination With Gemcitabine and Carboplatin in Metastatic Triple Negative Breast Cancer (mTNBC)
Public ClinicalTrials.gov record NCT02978716. 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.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Phase 2 Study of the Safety, Efficacy, and Pharmacokinetics of G1T28 in Patients With Metastatic Triple Negative Breast Cancer Receiving Gemcitabine and Carboplatin Chemotherapy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This was a study to investigate the potential clinical benefit of trilaciclib (G1T28) in preserving the bone marrow and the immune system, and enhancing chemotherapy antitumor efficacy when administered prior to carboplatin and gemcitabine (GC therapy) for participants with metastatic triple negative breast cancer. The study was an open-label and 102 participants were randomly assigned (1:1:1 fashion) to 1 of the 3 following treatment groups: * Group 1: GC therapy (Days 1 and 8 of 21-day cycles) only (n=34) * Group 2: GC therapy (Days 1 and 8) plus trilaciclib (G1T28) on Days 1 and 8 of 21-day cycles (n=33) * Group 3: GC therapy (Days 2 and 9) plus trilaciclib (G1T28) on Days 1, 2, 8, and 9 of 21-day cycles (n=35) The study included 3 study phases: Screening Phase, Treatment Phase, and Survival Follow-up Phase. The Treatment Phase begins on the day of first dose with study treatment and completes at the Post-Treatment Visit.
Study identification
- NCT ID
- NCT02978716
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 102 participants
Conditions and interventions
Conditions
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
- Feb 2, 2017 (Actual)
- Primary completion
- Jun 28, 2019 (Actual)
- Completion
- Feb 28, 2020 (Actual)
- Last update posted
- Mar 23, 2022
2017 – 2020
United States locations
- U.S. sites
- 35
- U.S. states
- 15
- U.S. cities
- 33
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Arizona Oncology Associates, PC - HOPE | Tucson | Arizona | 85704 | — |
| Disney Family Cancer Center | Burbank | California | 91505 | — |
| Sharp Clinical Oncology | San Diego | California | 92123 | — |
| Innovative Clinical Research Institute | Whittier | California | 90603 | — |
| Memorial UC Health | Colorado Springs | Colorado | 80909 | — |
| Rocky Mountain Cancer Centers | Lakewood | Colorado | 80228 | — |
| Florida Cancer Specialists | Fort Myers | Florida | 33916 | — |
| Florida Cancer Research Institute, LLC. | Plantation | Florida | 33324 | — |
| Florida Cancer Specialists - North (FCS North) | St. Petersburg | Florida | 33705 | — |
| Moffitt Cancer Center | Tampa | Florida | 33612 | — |
| Florida Cancer Specialists - East (FCS East) | West Palm Beach | Florida | 33401 | — |
| Saint Alphonsus Regional Medical Center | Boise | Idaho | 83706 | — |
| Illinois Cancer Specialists | Arlington Heights | Illinois | 60005 | — |
| Community Health Network | Indianapolis | Indiana | 46250 | — |
| University of Maryland Greenebaum Comprehensive Cancer Center | Baltimore | Maryland | 21201-1544 | — |
| The University of Maryland St. Joseph Medical Center | Towson | Maryland | 21204 | — |
| Saint Luke's Cancer Institute | Kansas City | Missouri | 64113 | — |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | 89128 | — |
| Levine Cancer Center | Charlotte | North Carolina | 28204 | — |
| Forsyth Memorial Hospital, Novant Health Oncology Specialists | Winston-Salem | North Carolina | 27103 | — |
| Tennessee Oncology | Chattanooga | Tennessee | 37404 | — |
| Tennessee Oncology | Nashville | Tennessee | 37203 | — |
| Texas Oncology-Dallas Presbyterian Hospital | Austin | Texas | 75231 | — |
| Texas Oncology, P.A. | Austin | Texas | 78745 | — |
| Texas Oncology, P.A. | Bedford | Texas | 76022 | — |
| Texas Oncology - Baylor Charles A. Sammons Cancer Center | Dallas | Texas | 75246 | — |
| Texas Oncology-El Paso Cancer Treatment Center Grandview | El Paso | Texas | 79902 | — |
| The Center for Cancer and Blood Disorders | Fort Worth | Texas | 76104 | — |
| Texas Oncology-San Antonio Northeast | San Antonio | Texas | 78217 | — |
| Tyler Hematology-Oncology, PA | Tyler | Texas | 75701 | — |
| Texas Oncology, P.A. | Tyler | Texas | 75702 | — |
| University of Virginia | Charlottesville | Virginia | 22908 | — |
| Virginia Cancer Specialists, PC | Fairfax | Virginia | 22031 | — |
| Virginia Oncology Associates | Virginia Beach | Virginia | 23456 | — |
| Northwest Medical Specialties, PLLC | Tacoma | Washington | 98405 | — |
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 19 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02978716, 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 Mar 23, 2022 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02978716 live on ClinicalTrials.gov.