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CDK4/6 Inhibitor

Trilaciclib for 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 28 weeks
Awards & highlights

Study Summary

This trial will study the effects of trilaciclib on early-stage triple negative breast cancer.

Eligible Conditions
  • Breast Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 28 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 28 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Immune-based Mechanism of Action
Secondary outcome measures
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Pathologic Complete Response (pCR) Rate
Other outcome measures
CDK4/6 dependence for clinical responsiveness
Immune response and clinical responsiveness
Intratumoral immune profile characterization following trilaciclib
+4 more

Side effects data

From 2019 Phase 1 & 2 trial • 122 Patients • NCT02499770
58%
Fatigue
42%
Anemia
42%
Neutropenia
42%
Leukopenia
42%
Nausea
42%
Alopecia
33%
Constipation
33%
Headache
33%
Vomiting
25%
Thrombocytopenia
25%
Pyrexia
25%
Diarrhea
17%
Dyspnea
17%
Edema peripheral
17%
Insomnia
17%
Arthralgia
17%
Dizziness
17%
Chills
8%
Pneumonia
8%
Dehydration
8%
Weight decreased
8%
Anxiety
8%
Blood creatinine increased
8%
Infusion related reaction
8%
Back pain
8%
Myocardial infarction
8%
Bone pain
8%
Cough
8%
Asthenia
8%
Night sweats
8%
Hyperglycemia
8%
Neck pain
8%
Urosepsis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part 2: Placebo
Part 1: Cohort 1 Trilaciclib 200 mg/m^2
Part 2: Trilaciclib 240 mg/m^2
Part 1: Cohort 2 Trilaciclib 240mg/m^2

Trial Design

1Treatment groups
Experimental Treatment
Group I: Trilaciclib plus chemotherapyExperimental Treatment6 Interventions
Trilaciclib lead-in, followed by trilaciclib plus anthracycline/cyclophosphamide, then trilaciclib plus taxane chemotherapy: Lead-in trilaciclib (240mg/m2) single dose monotherapy Trilaciclib (240mg/m2) + doxorubicin (60 mg/m2) + cyclophosphamide (600 mg/m2) + pembrolizumab (per Investigator discretion; 400mg) Trilaciclib (240mg/m2) + paclitaxel (80 mg/m2) + carboplatin (per Investigator discretion; AUC 1.5)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trilaciclib
2015
Completed Phase 4
~280
Cylophosphamide
2022
Completed Phase 2
~30
Doxorubicin
2012
Completed Phase 3
~7940
Paclitaxel
2011
Completed Phase 4
~5380
Carboplatin (Investigator discretion)
2022
Completed Phase 2
~30
Pembrolizumab (Investigator discretion)
2022
Completed Phase 2
~30

Find a Location

Who is running the clinical trial?

G1 Therapeutics, Inc.Lead Sponsor
21 Previous Clinical Trials
3,267 Total Patients Enrolled
4 Trials studying Breast Cancer
505 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.

Is this study actively seeking new participants?

"Clinicaltrials.gov reveals that this research, which was first published on November 19th 2021 and most recently updated on October 31st 2022, is currently not enrolling patients. However, there are 5425 other clinical trials actively recruiting at the present moment."

Answered by AI

Is this an unprecedented scientific experiment?

"Initially investigated in 1997 by Alfacell, Trilaciclib has been subject to numerous clinical trials since. Following a Phase 3 approval after the initial 300-person study, there are now over 2700 active tests being conducted in 4437 cities and 86 nations."

Answered by AI

Has Trilaciclib earned clearance from the FDA?

"Our team at Power has assessed the safety of Trilaciclib as a level 2, meaning that there is existing data affirming its security but no evidence validating its efficacy."

Answered by AI

How many participants are being enrolled in this trial?

"At this point, the trial is no longer searching for participants. This study was initially posted on November 19th 2021 and last updated October 31st 2022. If you are looking at other studies, there are 2663 trials recruiting patients with breast cancer and 2762 researching Trilaciclib actively enrolling."

Answered by AI

Are numerous medical facilities in the United States currently conducting this trial?

"The trial is being carried out at Virginia Oncology Associates in Norfolk, Cancer and Blood Specialty Clinic in Los Alamitos, and Nebraska Hematology-Oncology, P.C. based in Lincoln alongside 10 other medical centres."

Answered by AI

To what purpose is Trilaciclib typically administered?

"Trilaciclib is frequently prescribed to treat melanoma and other malignancies such as metastatic neoplasm, skin-based melanomas, and Kaposi's sarcoma related to acquired immunodeficiency syndrome."

Answered by AI

What other investigations have been completed regarding Trilaciclib?

"The initial clinical trials of trilaciclib were conducted at Spectrum Health Hospital's Butterworth Campus in 1997. As of now, there have been 2962 completed studies while 2762 are still ongoing; a large number of these surveys take place in Norfolk Virginia."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Trilaciclib, a CDK4/6 Inhibitor, in Patients With Early-Stage Triple Negative Breast Cancer
2022. "Trilaciclib, a CDK4/6 Inhibitor, in Patients With Early-Stage Triple Negative Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05112536.
~8 spots leftby Apr 2025
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