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Monoclonal Antibodies

Trilaciclib + Sacituzumab for Triple Negative Breast Cancer

Phase 2
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
ECOG performance status of 0 or 1
Adult (≥18 years of age), female or male patient with measurable (per RECIST v1.1), unresectable locally advanced or metastatic TNBC
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 36 months
Awards & highlights

Study Summary

This trial is testing a new cancer drug, trilaciclib, to see if it is safe and effective in treating triple-negative breast cancer.

Who is the study for?
This trial is for adults with advanced triple-negative breast cancer who have tried at least two systemic chemotherapy treatments. Participants must have measurable disease progression, be in fairly good health (ECOG status 0 or 1), and have normal organ function. They cannot join if they've had other cancers recently, are on immunosuppressants, have severe heart issues, untreated brain metastasis, certain genetic conditions like Gilbert's syndrome or UGT1A1*28 allele, only bone disease, recent serious bleeding or blockages in the digestive system.Check my eligibility
What is being tested?
The study tests Trilaciclib given before Sacituzumab Govitecan-hziy to see how safe and effective it is for those with unresectable or metastatic triple-negative breast cancer after failing previous therapies. It's an open-label Phase 2 trial where all participants receive the same treatment without a comparison group.See study design
What are the potential side effects?
Potential side effects include reactions related to immune response due to Sacituzumab Govitecan-hziy and Trilaciclib such as fatigue, nausea, low blood cell counts increasing infection risk; liver enzyme changes; allergic reactions during infusion of drugs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or can carry out light work.
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I am an adult with advanced or metastatic triple-negative breast cancer that cannot be surgically removed.
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My breast cancer worsened after 2 chemotherapy treatments.
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My organ functions are within normal ranges according to recent tests.
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My breast cancer is triple-negative according to ASCO/CAP standards.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 36 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
Progression free survival
Secondary outcome measures
Clinical benefit rate
Neutrophil-related myeloprotective effects
Objective response rate
+4 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Trilaciclib + Sacituzumab Govitecan-hziyExperimental Treatment2 Interventions
During the Treatment Phase patients will receive trilaciclib + sacituzumab govitecan-hziy on days 1 & 8 of a 21 day cycle. Trilaciclib is administered first, followed by sacituzumab govitecan-hziy. Administer diluted trilaciclib solution as a 30-minute IV infusion to be completed within 4 hours prior to the start of sacituzumab govitecan-hziy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sacituzumab Govitecan-hziy
2019
Completed Phase 3
~550
Trilaciclib
2015
Completed Phase 4
~280

Find a Location

Who is running the clinical trial?

G1 Therapeutics, Inc.Lead Sponsor
21 Previous Clinical Trials
3,261 Total Patients Enrolled
5 Trials studying Breast Cancer
529 Patients Enrolled for Breast Cancer
Clinical ConductStudy DirectorG1 Therapeutics, Inc.

Media Library

Sacituzumab Govitecan-hziy (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05113966 — Phase 2
Breast Cancer Research Study Groups: Trilaciclib + Sacituzumab Govitecan-hziy
Breast Cancer Clinical Trial 2023: Sacituzumab Govitecan-hziy Highlights & Side Effects. Trial Name: NCT05113966 — Phase 2
Sacituzumab Govitecan-hziy (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05113966 — Phase 2

Frequently Asked Questions

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

What additional investigations have been conducted on Sacituzumab Govitecan-hziy?

"At present, the landscape of Sacituzumab Govitecan-hziy clinical trials is comprised of 40 live studies - 8 in Phase 3. In Boston, MA alone there are several investigations underway; across all 1782 locations running research for this specific drug, countless more exist."

Answered by AI

How many individuals are engaging in this experiment?

"Indeed, the clinical trial is still accepting participants. According to data hosted on clinicialtrials.gov, which was last updated in October of 2022, this study seeks 45 individuals from 23 separate medical centres. It was originally posted in November 2021."

Answered by AI

In what locations are the participants of this clinical trial being recruited?

"This study is currently recruiting from 23 distinct centres, with locations in Whittier, Tyler and Chandler as well as 20 other cities. To best accommodate participants, it would be beneficial to select the nearest site available."

Answered by AI

Are there presently any opportunities for enrollment in this investigation?

"Affirmative. The clinical trial's information on clinicaltrials.gov states that it is currently recruiting participants, with the initial post having been made on November 22nd 2021 and last edited on October 25th 2022. 45 patients are required from 23 different sites for this project."

Answered by AI

What maladies has Sacituzumab Govitecan-hziy been found to ameliorate?

"Sacituzumab Govitecan-hziy is a viable solution for managing bone marrow conditions, and has been observed to provide successful outcomes when used in therapeutic procedures, pharmacotherapies, and treatments of malignant neoplasms."

Answered by AI

What possible adverse effects can arise from using Sacituzumab Govitecan-hziy?

"Although there is no clinical evidence yet that sacituzumab govitecan-hziy is effective, its safety has been partially validated in a Phase 2 trial. Our team at Power thus gave it an assessment of 2 on the 1 to 3 scale."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Trilaciclib in Patients Receiving Sacituzumab Govitecan-hziy for Triple Negative Breast Cancer
2021. "Trilaciclib in Patients Receiving Sacituzumab Govitecan-hziy for Triple Negative Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05113966.
All > Breast Cancer High Point
~9 spots leftby Apr 2025
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