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Alkylating agents

Combination Chemotherapy + Immunotherapy for Breast Cancer (ToPCourT Trial)

Phase 2

Recruiting

Led By Antoinette Tan, MD

Research Sponsored by Wake Forest University Health Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Female patients: All females of childbearing potential must have a negative serum β-human chorionic gonadotropin (hCG) test result at Screening and negative serum or urine pregnancy test results within 72 hours prior to day 1 of study treatment

Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1 evaluated within 28 days prior to day 1 of study treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year (initiation of protocol directed therapy until documented death, or end of follow-up period])

Awards & highlights

ToPCourT Trial Summary

This trial tests a new anti-cancer therapy combo in people with advanced breast cancer. It will assess how well it works and how well the body can handle it.

Who is the study for?

This trial is for adults with advanced triple-negative breast cancer that hasn't spread to the brain. Participants must have negative hormone receptor tests, be expected to live at least 12 weeks, and have measurable disease. They should understand the study procedures and agree to provide tissue samples. Women of childbearing age must test negative for pregnancy and use contraception.Check my eligibility

What is being tested?

The trial is testing a combination of drugs: Trilaciclib, Pembrolizumab (an immunotherapy), Gemcitabine, and Carboplatin in patients with metastatic triple-negative breast cancer. It aims to assess how effective this mix is against cancer and how well patients tolerate it.See study design

What are the potential side effects?

Possible side effects include reactions related to immune system activation such as inflammation in various organs, fatigue, blood cell count changes leading to increased infection risk or bleeding problems, nausea or vomiting from chemotherapy agents like Gemcitabine and Carboplatin.

ToPCourT Trial Eligibility Criteria

Inclusion Criteria

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

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I am a woman able to have children and have tested negative for pregnancy.

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I am fully active or restricted in physically strenuous activity but can do light work.

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I have advanced or spreading triple-negative breast cancer that cannot be surgically removed.

ToPCourT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year (initiation of protocol directed therapy until documented death, or end of follow-up period])

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year (initiation of protocol directed therapy until documented death, or end of follow-up period])

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year (initiation of protocol directed therapy until documented death, or end of follow-up period]) for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Objective Response

Secondary outcome measures

Duration of response

Overall survival

Progression-free survival

ToPCourT Trial Design

1Treatment groups

Experimental Treatment

Group I: Trilaciclib, Pembrolizumab, Gemcitabine, and CarboplatinExperimental Treatment4 Interventions

Trilaciclib is an agent that helps protect the bone marrow from the side effects of chemotherapy. It is given as an intravenous (IV) infusion over 30 minutes prior to gemcitabine and carboplatin. Gemcitabine is given IV over 30 minutes. Carboplatin is given over 30 minutes. Trilaciclib, gemcitabine and carboplatin are given on Days 1 and 8 every 21 days. Pembrolizumab is given IV over 30 minutes on Day 1 every 21 days.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Trilaciclib

2015

Completed Phase 4

~280

Gemcitabine

2017

Completed Phase 3

~2070

Pembrolizumab

2017

Completed Phase 2

~2010

Carboplatin

2014

Completed Phase 3

~6670

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor

1,243 Previous Clinical Trials

1,004,694 Total Patients Enrolled

35 Trials studying Breast Cancer

5,087 Patients Enrolled for Breast Cancer

G1 Therapeutics, Inc.Industry Sponsor

21 Previous Clinical Trials

3,255 Total Patients Enrolled

5 Trials studying Breast Cancer

529 Patients Enrolled for Breast Cancer

Merck Sharp & Dohme LLCIndustry Sponsor

3,892 Previous Clinical Trials

5,061,110 Total Patients Enrolled

59 Trials studying Breast Cancer

7,498 Patients Enrolled for Breast Cancer

Frequently Asked Questions

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

To what extent can Trilaciclib, Pembrolizumab, Gemcitabine, and Carboplatin be hazardous for those undergoing treatment?

"Our team evaluated the safety of Trilaciclib, Pembrolizumab, Gemcitabine and Carboplatin with a score of 2 due to the lack of clinical data in support for efficacy. Nonetheless, some evidence exists that indicates this combination is safe."

Answered by AI

Are there any remaining opportunities to enroll in this medical research?

"Unfortunately, this trial is no longer welcoming any new patients according to the information found on clinicaltrials.gov. It was initially posted on September 1st 2023 and last updated August 31st of that same year. However, 2464 other trials are still open for recruitment at this time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase II Trial of Trilaciclib, Pembrolizumab, Gemcitabine and Carboplatin in Metastatic Triple-Negative Breast Cancer

2024. "Phase II Trial of Trilaciclib, Pembrolizumab, Gemcitabine and Carboplatin in Metastatic Triple-Negative Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06027268.

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