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Platinum-based compound

Trilaciclib + Chemotherapy for Breast Cancer (PRESERVE 2 Trial)

Phase 3
Waitlist Available
Research Sponsored by G1 Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age >/= 18 years of age with evaluable locally advanced unresectable or metastatic TNBC
For Cohort 1: No prior systemic therapy in the locally advanced unresectable/metastatic setting including chemotherapy, targeted therapy, immunotherapy, or investigational agents
Must not have
Prior hematopoietic stem cell or bone marrow transplantation
Presence of central nervous system (CNS) metastases and/or leptomeningeal disease requiring immediate treatment with radiation therapy or steroids
Timeline
Screening 3 weeks
Treatment Varies
Follow Up cohort 2: from date of randomization up to 28 months
Awards & highlights
Pivotal Trial

Summary

This trial is testing a new drug to see if it is safe and effective in treating patients with a certain type of breast cancer.

Who is the study for?
This trial is for adults with advanced or metastatic triple-negative breast cancer who haven't had certain prior treatments, including PD-1/PD-L1 inhibitors and gemcitabine. They should be relatively healthy (ECOG 0 or 1) and have tumor tissue available for study. Pregnant women, those with known hypersensitivity to the drugs used, or recent chemotherapy recipients are excluded.
What is being tested?
The trial is testing Trilaciclib, a CDK 4/6 inhibitor, given before standard chemo drugs Gemcitabine and Carboplatin versus a placebo. It's designed to see if Trilaciclib improves outcomes in first- or second-line treatment of metastatic triple-negative breast cancer.
What are the potential side effects?
Trilaciclib may cause side effects like fatigue, nausea, low blood cell counts increasing infection risk, liver issues, and potential harm to an unborn baby; hence it's not for pregnant women. Standard chemo side effects include hair loss, nausea/vomiting.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 or older with advanced triple-negative breast cancer that cannot be surgically removed.
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I have not had any treatment for my advanced cancer.
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I am 18 or older with advanced triple-negative breast cancer that cannot be surgically removed.
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I have never been treated with PD-1/PD-L1 inhibitors.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My breast cancer is triple negative.
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It has been 6 months or more since my last curative treatment and the first sign of cancer spreading.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have had a bone marrow or stem cell transplant.
Select...
I need urgent treatment for cancer spread to my brain or spinal cord.
Select...
I have been treated with gemcitabine before.
Select...
I have been treated with carboplatin for advanced cancer that cannot be surgically removed.
Select...
I haven't had chemotherapy in the last 14 days.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~cohort 2: from date of randomization up to 28 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and cohort 2: from date of randomization up to 28 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Effect on Overall Survival (OS)
Secondary study objectives
Myeloprotective Effects
Progression Free Survival
Quality of life/Effects On Chemotherapy-Induced Fatigue

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Trilaciclib + gemcitabine + carboplatinExperimental Treatment3 Interventions
Trilaciclib (240mg/m2) + gemcitabine (1000 mg/m2) and carboplatin (AUC 2)
Group II: Placebo + gemcitabine + carboplatinPlacebo Group3 Interventions
The subjects in the placebo arm will follow the same schedule as the trilaciclib arm, but will receive placebo instead of trilaciclib.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gemcitabine
2017
Completed Phase 3
~1920
Trilaciclib
2015
Completed Phase 4
~400
Carboplatin
2014
Completed Phase 3
~6120

Find a Location

Who is running the clinical trial?

G1 Therapeutics, Inc.Lead Sponsor
21 Previous Clinical Trials
3,097 Total Patients Enrolled
4 Trials studying Breast Cancer
335 Patients Enrolled for Breast Cancer
Clinical ContactStudy DirectorG1 Therapeutics, Inc.
10 Previous Clinical Trials
1,121 Total Patients Enrolled
3 Trials studying Breast Cancer
311 Patients Enrolled for Breast Cancer

Media Library

Carboplatin (Platinum-based compound) Clinical Trial Eligibility Overview. Trial Name: NCT04799249 — Phase 3
Breast Cancer Research Study Groups: Trilaciclib + gemcitabine + carboplatin, Placebo + gemcitabine + carboplatin
Breast Cancer Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT04799249 — Phase 3
Carboplatin (Platinum-based compound) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04799249 — Phase 3
~42 spots leftby Dec 2025
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