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Platinum-based compound

Trilaciclib + Chemotherapy for Breast Cancer (PRESERVE 2 Trial)

Q: In how many different medical clinics is this medical study being run today?

<p>Patients are being enrolled at the <a href="https://www.withpower.com/clinical-trials/texas">Texas</a> <a href="https://www.withpower.com/clinical-trials/oncology">Oncology</a>-Baylor Charles A. Sammons <a href="https://www.withpower.com/clinical-trials/cancer">Cancer</a> Center in Dallas, Texas, as well as 30 other locations across the state.</p>

Q: What are some of the conditions that Trilaciclib has been shown to be effective against?

<p>Trilaciclib is frequently used to treat <a href="https://www.withpower.com/clinical-trials/lymphoma">lymphoma</a>, non-hodgkin. It can also be useful for patients undergoing haemodiafiltration, initial treatment, and urinary bladder procedures.</p>

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up cohort 2: from date of randomization up to 28 months

Awards & highlights

PRESERVE 2 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.Check my eligibility

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.See study design

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.

PRESERVE 2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 or older with advanced triple-negative breast cancer that cannot be surgically removed.

Select...

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.

Select...

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.

Select...

It has been 6 months or more since my last curative treatment and the first sign of cancer spreading.

PRESERVE 2 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ cohort 2: from date of randomization up to 28 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Effect on Overall Survival (OS)

Secondary outcome measures

Myeloprotective Effects

Progression Free Survival

Quality of life/Effects On Chemotherapy-Induced Fatigue

PRESERVE 2 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

~2070

Trilaciclib

2015

Completed Phase 4

~280

Carboplatin

2014

Completed Phase 3

~6670

0 / 7Eligibility criteria met

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are receiving care through this clinical trial?

"This study is not currently looking for new participants. It was first posted on April 15th, 2021 and updated on October 25th, 2022. For patients who are interested in other studies, there are 2761 trials for breast cancer and 1111 trials for Trilaciclib that are still recruiting patients."

Answered by AI

When can patients in the USA expect to have access to Trilaciclib?

"There is prior clinical data supporting Trilaciclib's safety, so it received a score of 3."

Answered by AI

Are Trilaciclib clinical trials a common occurrence?

"Trilaciclib has 1111 ongoing clinical trials, with the majority of them being in Phase 3. The most frequent location for these trials is Shanghai, but there are a total of 60844 locations where Trilaciclib trials are taking place."

Answered by AI

In how many different medical clinics is this medical study being run today?

"Patients are being enrolled at the Texas Oncology-Baylor Charles A. Sammons Cancer Center in Dallas, Texas, as well as 30 other locations across the state."

Answered by AI

What are some of the conditions that Trilaciclib has been shown to be effective against?

"Trilaciclib is frequently used to treat lymphoma, non-hodgkin. It can also be useful for patients undergoing haemodiafiltration, initial treatment, and urinary bladder procedures."

Answered by AI

Are enrollees still being sought for this experiment?

"According to the information available on clinicaltrials.gov, this particular trial is not recruiting patients at this time. The study was originally posted on April 15th, 2021 and edited for the last time on October 25th, 2022. There are 3872 other trials that are actively enrolling participants right now."

Answered by AI