18 and older, female only, with Triple Negative Breast Cancer or Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Immune-based Mechanism of ActionPrimary· Up to 8 days after lead-in trilaciclib dose
Evaluated 7 days after a single-dose of trilaciclib, measured by the change in CD8+ T cells/regulatory T cells (Treg) ratio in tumor tissue; post-trilaciclib ratio minus pre-trilaciclib ratio.
Research shows a correlation between immune cells, (tumor-infiltrating lymphocytes - TILs), and favorable outcomes. Both the presence of effector CD8+ T cells and the ratio of effector CD8+ T cells to immune-suppressive regulatory T cells (Treg) correlate with improved outcome and long-term survival in solid cancers. Therefore, the higher the ratio of CD8+ T cells/Tregs, the better the predicted outcome
Group
Value
95% CI
Trilaciclib Plus Chemotherapy
0.3
-0.5 – 2.7
Pathologic Complete Response (pCR) RateSecondary· Up to 26 weeks
Rate of pCR using the definition of ypT0/Tis ypN0 (i.e., no invasive residual tumor in breast or nodes; noninvasive breast residuals allowed) as assessed by the local pathologist.
Achieved pCR
Group
Value
95% CI
Trilaciclib Plus Chemotherapy
10
Did not achieve pCR
Group
Value
95% CI
Trilaciclib Plus Chemotherapy
14
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)Secondary· Up to 28 weeks
Safety/tolerability as per Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Adverse Events CTCAE grade >/= 3
Group
Value
95% CI
Trilaciclib Plus Chemotherapy
15
Adverse Events CTCAE grade >/= 4
Group
Value
95% CI
Trilaciclib Plus Chemotherapy
5
Study drug related adverse event
Group
Value
95% CI
Trilaciclib Plus Chemotherapy
24
Study drug related serious adverse event
Group
Value
95% CI
Trilaciclib Plus Chemotherapy
2
Trilaciclib-related adverse event leading to discontinuation
Group
Value
95% CI
Trilaciclib Plus Chemotherapy
0
Adverse event leading to death
Group
Value
95% CI
Trilaciclib Plus Chemotherapy
0
Trilaciclib adverse events of special interest (AESI)
Group
Value
95% CI
Trilaciclib Plus Chemotherapy
10
Adverse events — posted to ClinicalTrials.gov
Time frame: 28 weeks.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Trilaciclib Plus Chemotherapy
Serious: 4/24 (17%)
Deaths: 0/24
Serious adverse events (14 terms)
Reaction
System
Trilaciclib Plus Chemother…
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
—
Abscess limb
Infections and infestations
—
COVID-19
Infections and infestations
—
Herpes simplex encephalitis
Infections and infestations
—
Pneumonia
Infections and infestations
—
Sepsis
Infections and infestations
—
Urosepsis
Infections and infestations
—
Pulmonary fibrosis
Respiratory, thoracic and mediastinal disorders
—
Deep vein thrombosis
Vascular disorders
—
Orthostatic hypotension
Vascular disorders
—
Febrile neutropenia
Blood and lymphatic system disorders
—
Colitis
Gastrointestinal disorders
—
Physical deconditioning
General disorders
—
Hypertransaminasaemia
Hepatobiliary disorders
—
Other adverse events (161 terms — click to expand)
The purpose of this study is to evaluate the mechanism of action, as well as the safety and efficacy of trilaciclib in combination with standard of care treatment in the neoadjuvant setting of early-stage triple negative breast cancer (TNBC).
This study will have four phases: 1) Screening Phase, 2) Trilaciclib Lead-In Phase, 3) Treatment Phase, and 4) Surgery and Follow-Up Phase. After a screening phase of up to 21 day, each participant will receive trilaciclib single-dose monotherapy during the lead-in phase, followed by a tumor biopsy. During the treatment phase, each participant will receive trilaciclib with standard of care chemotherapy. Immunotherapy may be included during the treatment phase, per standard of care. 3-5 weeks following conclusion of the treatment phase, each participant will undergo definitive surgery. A 30-day Safety Follow-up Visit will occur 30 days after the last dose of trilaciclib and an End of Study Visit will occur within 14 days after definitive surgery.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07255612 — Bone Marrow Protection, Safety, Efficacy of Trilaciclib and Eribulin in Locally Advanced or Metastatic TNBC(Triple-negat
· Phase 2
· not yet recruiting
NCT06714266 — Trilaciclib in Preventing Hematopoietic Suppression in Patients with Recurrent or Metastatic Head and Neck Squamous Cell
· Phase 2
· not yet recruiting
NCT06698965 — Efficacy and Safety of First-line Treatment for Extensive-stage Small Cell Lung Cancer Using a Combination Therapy of Tr
· Phase 2
· recruiting
NCT06370416 — the Prevention of Bone Marrow Suppression Caused by Chemotherapy in Advanced NSCLC With Trilaciclib
· Phase 2
· enrolling by invitation
Other recruiting trials for Triple Negative Breast Cancer
Currently open trials in the same condition.
NCT07533123 — A Phase III Study of JSKN016 Versus Treatment of Physician's Choice in Patients With Triple-Negative Breast Cancer Who H
· Phase 3
· recruiting
NCT07503808 — A Study of IDE034 in Adult Participants With Locally Advanced/Metastatic Solid Tumors Types
· Phase 1
· recruiting
NCT07281976 — A Trial of LBL-024 Monotherapy or Combination Drug in Patients With Triple Negative Breast Cancer
· Phase 1, PHASE2
· recruiting
NCT06225505 — Early Detection of Triple Negative Breast Cancer Relapse (CUPCAKE)
· NA
· recruiting
Other G1 Therapeutics, Inc. trials
Trials by the same sponsor.
NCT05113966 — Trilaciclib in Patients Receiving Sacituzumab Govitecan-hziy for Triple Negative Breast Cancer
· Phase 2
· terminated
NCT04887831 — Trilaciclib, a CDK 4/6 Inhibitor, in Patients With Advanced/Metastatic Bladder Cancer Receiving Chemotherapy Then Avelum
· Phase 2
· terminated
NCT04799249 — Trilaciclib, a CDK 4/6 Inhibitor, in Patients Receiving Gemcitabine and Carboplatin for Metastatic Triple-Negative Breas
· Phase 3
· completed
NCT04863248 — Trilaciclib, a CDK 4/6 Inhibitor, in Patients Receiving Docetaxel for Metastatic Non-Small Cell Lung Cancer (NSCLC) (PRE
· Phase 2
· terminated
NCT04607668 — Trilaciclib, a CDK 4/6 Inhibitor, in Patients Receiving FOLFOXIRI/Bevacizumab for Metastatic Colorectal Cancer (mCRC):
· Phase 3
· terminated
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by G1 Therapeutics, Inc.
Last refreshed: 12 March 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05112536.