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Active, not recruitingNCT06027268ToPCourTUpdated Aug 20, 2026

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

A Phase 2 interventional study of Trilaciclib and Pembrolizumab in Metastatic Triple-Negative Breast Cancer, sponsored by Wake Forest University Health Sciences. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-20.

Sponsored by Wake Forest University Health Sciences · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
36
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The goal of this phase II study is to test the combination of trilaciclib, pembrolizumab, gemcitabine, and carboplatin in locally advanced unresectable or metastatic triple-negative breast cancer.

The main questions it aims to answer are:

  • to evaluate the anti-cancer efficacy (assess how well it works)
  • to evaluate the safety and tolerability (how well the body can handle the treatment) of this combination of anti-cancer therapy
Read the detailed description

This is an open label, single-arm, phase II trial designed to evaluate the efficacy of trilaciclib, pembrolizumab, gemcitabine and carboplatin in participants with locally advanced unresectable or metastatic triple-negative breast cancer. Pembrolizumab will be given for a maximum of 2 years. Eligible participants will receive the study treatment until disease progression, unacceptable toxicity, or withdrawal for any reason. A tumor biopsy will be collected from participants in which it can be safely obtained before the first dose of treatment, prior to Cycle 3 Day 1, and at the time of disease progression (optional). Blood specimens for correlative studies will be collected pre-treatment Cycle 1 Day 1, prior to treatment Cycle 2 Day 1, prior to treatment Cycle 3 Day 1, 3 months after the start of study treatment, and 6 months after the start of study treatment.

02

Conditions studied

  • Metastatic Triple-Negative Breast Cancer

Keywords

  • Breast-Female
  • Breast-Male
  • Triple-Negative Breast Cancer
  • Metastatic
  • Locally advanced unresectable
03

In context

Triple Negative Breast Neoplasms

1,140 studies on the registry are indexed under Triple Negative Breast Neoplasms; 443 are open to participants now.

This study's planned enrollment of 36 is below the median of 61 across 982 interventional studies indexed under Triple Negative Breast Neoplasms.

Browse Triple Negative Breast Neoplasms studies →

Lead sponsor

Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.

Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Written informed consent and HIPAA authorization for release of personal health information signed by the patient
  2. Male or female with locally advanced unresectable or metastatic TNBC
  3. Age ≥ 18 years at the time of consent
  4. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1 evaluated within 28 days prior to day 1 of study treatment
  5. Histological or cytological confirmation of estrogen negative and progesterone negative tumor, defined as \< 10% staining on immunohistochemistry (IHC) and human epidermal growth factor receptor type 2 (HER2)-negative, defined as HER 2 IHC 0 or 1+ or IHC 2+ with no amplification. Patients may be enrolled regardless of their PD-L1 (programmed death ligand-1) status.
  6. Measurable disease according to response evaluation criteria in solid tumors
  7. Demonstrate adequate organ function
  8. 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.
  9. Subject agrees to use contraception
  10. As determined by the enrolling physician, the ability of the subject to understand and comply with study procedures for the entire length of the study
  11. Tumor tissue: Willing to provide tumor tissue for research purposes
  12. Subject has a life expectancy of ≥ 12 weeks

Exclusion criteria

Exclusion Criteria:

  1. More than 3 prior lines of chemotherapy for locally advanced unresectable or triple-negative metastatic disease
  2. Prior therapy with the concurrent combination of gemcitabine and carboplatin in the metastatic setting
  3. Active, symptomatic central nervous system (CNS) metastases and/or carcinomatous meningitis or CNS metastases that are progressing on screening magnetic resonance imaging (MRI) brain.
  4. Prior systemic anti-cancer therapy within 3 weeks, prior stereotactic radiotherapy within 1 week, and radiation within 2 weeks of day 1 of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation to non-CNS disease.
  5. Major surgery, defined by the investigator's discretion, within 3 weeks of day 1 of study treatment
  6. Not recovered from all reversible acute toxic effects of prior therapy, including non-hematologic toxicities related to prior systemic therapy to ≤ Grade 1. Participants with less than Grade 2 neuropathy or alopecia of any grade are an exception
  7. Active infection requiring systemic therapy
  8. Pregnant or breastfeeding
  9. Participants previously diagnosed with an additional malignancy must be disease-free for at least five years prior to enrollment. Exceptions include basal cell or squamous cell skin cancer and in situ cervical or bladder cancer.
  10. Treatment with any investigational drug within 30 days or at least 5 half-lives, whichever is longer, prior to day 1 of study treatment
  11. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, uncontrolled symptomatic congestive heart failure (Class III or IV as defined by the New York Heart Association (NYHA) functional classification system), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations/substance abuse that would limit compliance with study requirements as determined by the investigator
  12. Known history of stroke or cerebrovascular event within 6 months prior to the day 1 of study treatment
  13. Known hypersensitivity to carboplatin or other platinum-containing compounds, gemcitabine, mannitol, or pembrolizumab
  14. History of non-infectious interstitial lung disease (ILD)/pneumonitis that required steroids or current ILD/ pneumonitis.
  15. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs) prior to day 1 of study treatment. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed
  16. Prior hematopoietic stem cell or bone marrow transplant or allogenic tissue/solid organ transplant
  17. Has a known history of Human Immunodeficiency Virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
  18. Has known active hepatitis B (e.g., hepatitis B surface antigen [HBsAg] reactive).
  19. Has known active hepatitis C (e.g., hepatitis C virus (HCV) ribonucleic acid (RNA) [qualitative] is detected).
  20. Receipt of a live, attenuated vaccine within 30 days prior to day 1 of study treatment or anticipation that such a live, attenuated vaccine will be required during the study treatment period. Administration of killed vaccines is allowed. Exception: Monkeypox vaccine may be given if there are at least 3 days between the vaccine and initiation of study treatment.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
36 participants (estimated)

Study arms

  • Experimental
    Trilaciclib, Pembrolizumab, Gemcitabine, and Carboplatin

    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.

    Drug: Trilaciclib · Drug: Pembrolizumab · Drug: Gemcitabine · Drug: Carboplatin

Interventions

  • DrugTrilaciclib

    IV infusion Day 1 and Day 8 every 21 days, at dose of 240 mg/m2

    Also known as: COSELA

  • DrugPembrolizumab

    IV infusion Day 1 every 21 days, at dose of 200 mg

    Also known as: KEYTRUDA

  • DrugGemcitabine

    IV infusion Day 1 and Day 8 every 21 days, at dose 1000 mg/m2

    Also known as: Gemzar

  • DrugCarboplatin

    IV infusion Day 1 and Day 8 every 21 days, at dose area under curve (AUC) 2 (maximum of 300 mg)

06

What researchers measure

Primary outcomes

  1. Objective Response

    Objective according to RECIST v1.1 criteria

    Time frame: 6 months (initiation of protocol directed therapy until either a partial response is achieved or treatment discontinuation)

Secondary outcomes

  1. Progression-free survival

    Time to disease progression per RECIST v1.1 criteria or death

    Time frame: 1 year (initiation of protocol directed therapy until documented disease progression, death, or end of follow-up period)

  2. Duration of response

    Duration of response will be calculated only for subjects who achieve an objective response according to RECIST v1.1 criteria (a CR or PR). Disease progression will be objectively determined as per RECIST 1.1 criteria or progression can be subjective as determined by the Investigator.

    Time frame: 1 year (time from first disease assessment that shows a PR or complete response (CR) until documented disease progression, death, or end of follow-up period)

  3. Overall survival

    Time to date of death due to any cause while on study

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

Other outcomes

  1. Adverse Events

    Trilaciclib, pembrolizumab, gemcitabine, and carboplatin treatment administration AEs while on study therapy

    Time frame: 30 days (initiation of protocol directed therapy until 30 days after last dose, or removal from study while on treatment)

  2. Serious Adverse Events

    Trilaciclib, pembrolizumab, gemcitabine, and carboplatin treatment administration SAEs while on study therapy

    Time frame: 30 days (initiation of protocol directed therapy until 30 days after last dose, or removal from study while on treatment)

  3. Adverse Event Related Dose Delays

    Trilaciclib, pembrolizumab, gemcitabine, and carboplatin treatment administration AE-related dose delays while on study therapy

    Time frame: 30 days (initiation of protocol directed therapy until 30 days after last dose, or removal from study while on treatment)

  4. Dose Reductions

    Trilaciclib, pembrolizumab, gemcitabine, and carboplatin treatment administration dose reductions while on study therapy

    Time frame: 30 days (initiation of protocol directed therapy until 30 days after last dose, or removal from study while on treatment)

  5. Treatment Discontinuation

    Trilaciclib, pembrolizumab, gemcitabine, and carboplatin treatment administration treatment discontinuation while on study therapy

    Time frame: 30 days (initiation of protocol directed therapy until 30 days after last dose, or removal from study while on treatment)

  6. Deaths

    Trilaciclib, pembrolizumab, gemcitabine, and carboplatin treatment administration deaths while on study therapy

    Time frame: 30 days (initiation of protocol directed therapy until 30 days after last dose, or removal from study while on treatment)

07

Study locations

1 site
  • Levine Cancer Institute
    Charlotte, North Carolina 28204, United States
08

References and documents

Publications

  • Tan AR, Wright GS, Thummala AR, Danso MA, Popovic L, Pluard TJ, Han HS, Vojnovic Z, Vasev N, Ma L, Richards DA, Wilks ST, Milenkovic D, Yang Z, Antal JM, Morris SR, O'Shaughnessy J. Trilaciclib plus chemotherapy versus chemotherapy alone in patients with metastatic triple-negative breast cancer: a multicentre, randomised, open-label, phase 2 trial. Lancet Oncol. 2019 Nov;20(11):1587-1601. doi: 10.1016/S1470-2045(19)30616-3. Epub 2019 Sep 28. PubMed 31575503 ↗
  • Tan AR, Wright GS, Thummala AR, Danso MA, Popovic L, Pluard TJ, Han HS, Vojnovic Z, Vasev N, Ma L, Richards DA, Wilks ST, Milenkovic D, Xiao J, Sorrentino J, Horton J, O'Shaughnessy J. Trilaciclib Prior to Chemotherapy in Patients with Metastatic Triple-Negative Breast Cancer: Final Efficacy and Subgroup Analysis from a Randomized Phase II Study. Clin Cancer Res. 2022 Feb 15;28(4):629-636. doi: 10.1158/1078-0432.CCR-21-2272. PubMed 34887261 ↗
  • Tan AR, O'Shaughnessy J, Cao S, Ahn S, Yi JS. Investigating potential immune mechanisms of trilaciclib administered prior to chemotherapy in patients with metastatic triple-negative breast cancer. Breast Cancer Res Treat. 2023 Sep;201(2):307-316. doi: 10.1007/s10549-023-07009-8. Epub 2023 Jul 7. PubMed 37418031 ↗
  • Sears-Smith MB, Matusz-Fisher A, Symanowski JT, Tan AR. ToPCourT protocol: a phase II trial of Trilaciclib, Pembrolizumab, gemcitabine, and Carboplatin in locally advanced/unresectable or metastatic Triple-negative breast cancer. Future Oncol. 2026 Apr;22(8):911-917. doi: 10.1080/14796694.2026.2639737. Epub 2026 Mar 11. PubMed 41810725 ↗

Study documents

  • Informed consent form · Feb 11, 2026

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06027268
Lead sponsor
Wake Forest University Health Sciences
Collaborators
Merck Sharp & Dohme LLC, G1 Therapeutics, Inc.
Responsible party
Sponsor
First posted
Sep 7, 2023
Start date
Jan 10, 2024
Primary completion
Aug 2027 (estimated)
Completion
Aug 2027 (estimated)
Last update
Aug 20, 2026

Study contacts

Antoinette Tan, MD
principal investigator · Wake Forest University Health Sciences

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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