NCT04799249 (PRESERVE 2) is a Phase 3 clinical trial of Trilaciclib in TNBC - Triple-Negative Breast Cancer, sponsored by G1 Therapeutics, Inc..

Who is sponsoring NCT04799249?

NCT04799249 is sponsored by G1 Therapeutics, Inc..

What drugs are being tested in NCT04799249?

Interventions in NCT04799249: Trilaciclib, Placebo, Gemcitabine, Carboplatin.

What condition does NCT04799249 study?

NCT04799249 studies TNBC - Triple-Negative Breast Cancer, Breast Cancer.

Is NCT04799249 still recruiting?

NCT04799249 is currently completed. Last updated 1 August 2024.

Last reviewed 2024-08-01 · How we verify

NCT04799249: PRESERVE 2

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Trilaciclib, a CDK 4/6 Inhibitor, in Patients Receiving Gemcitabine and Carboplatin for Metastatic Triple-Negative Breast Cancer (TNBC)

Completed Phase 3 Last updated 1 August 2024

What this trial tests

Phase 3 trial testing Trilaciclib in TNBC - Triple-Negative Breast Cancer in 194 participants. Completed in 24 May 2024.

Timeline

14 May 2021

Primary endpoint
24 May 2024

24 May 2024

Quick facts

Lead sponsor	G1 Therapeutics, Inc.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	194
Start date	14 May 2021
Primary completion	24 May 2024
Estimated completion	24 May 2024
Sites	71 locations across Georgia, France, Russia, Ukraine, Moldova, Poland, Bulgaria, Australia

Drugs / interventions tested

Trilaciclib — full drug profile →
Placebo
Gemcitabine (gemcitabine) — full drug profile →
Carboplatin (Carboplatin) — full drug profile →

Conditions studied

TNBC - Triple-Negative Breast Cancer — all drugs for TNBC - Triple-Negative Breast Cancer →
Breast Cancer — all drugs for Breast Cancer →

Sponsor

G1 Therapeutics, Inc. — full company profile →

Who can join

18 and older, any sex, with TNBC - Triple-Negative Breast Cancer or Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of trilaciclib versus placebo administered prior to gemcitabine and carboplatin in patients receiving first- or second-line treatment for locally advanced unresectable/metastatic TNBC.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Recent advances in therapeutic strategies for triple-negative breast cancer.
Li Y, Zhang H, Merkher Y, Chen L, et al · · 2022 · cited 643× · PMID 36038913 · DOI 10.1186/s13045-022-01341-0
Targeting CDK4 and CDK6 in cancer.
Goel S, Bergholz JS, Zhao JJ. · · 2022 · cited 392× · PMID 35304604 · DOI 10.1038/s41568-022-00456-3
Recent advances in targeted strategies for triple-negative breast cancer.
Zhu S, Wu Y, Song B, Yi M, et al · · 2023 · cited 200× · PMID 37641116 · DOI 10.1186/s13045-023-01497-3
Human disease models in drug development.
Loewa A, Feng JJ, Hedtrich S. · · 2023 · cited 164× · PMID 37359774 · DOI 10.1038/s44222-023-00063-3
Cyclin-dependent protein kinases and cell cycle regulation in biology and disease.
Pellarin I, Dall'Acqua A, Favero A, Segatto I, et al · · 2025 · cited 132× · PMID 39800748 · DOI 10.1038/s41392-024-02080-z
Therapeutic progress and challenges for triple negative breast cancer: targeted therapy and immunotherapy.
Yang R, Li Y, Wang H, Qin T, et al · · 2022 · cited 86× · PMID 35243562 · DOI 10.1186/s43556-022-00071-6
Potential Prospect of CDK4/6 Inhibitors in Triple-Negative Breast Cancer.
Hu Y, Gao J, Wang M, Li M. · · 2021 · cited 43× · PMID 34234565 · DOI 10.2147/cmar.s310649
Targeting triple-negative breast cancer: A clinical perspective.
Popovic LS, Matovina-Brko G, Popovic M, Punie K, et al · · 2023 · cited 29× · PMID 37305385 · DOI 10.32604/or.2023.028525

Verify or expand the search:

Other trials of Trilaciclib

Trials testing the same drug.

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
NCT06490081 — Trilaciclib Prevents Myelosuppression With Chemoradiotherapy · 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 TNBC - Triple-Negative Breast Cancer

Currently open trials in the same condition.

NCT07351487 — Neoadjuvant Chemotherapy Combined With Sintilimab and Bevacizumab for TNBC (NEOTORCH-BREAST07) · Phase 2 · recruiting
NCT06637306 — Neoadjuvant Dupilumab, Pembrolizumab, Paclitaxel, and Carboplatin in Locally Advanced Triple Negative Breast Cancer · EARLY_PHASE1 · recruiting
NCT07046455 — Trop-2 Targeted PET Probes in Advanced TNBC · NA · recruiting
NCT06627712 — SBRT Combined With PD-1 Inhibitor and Chemotherapy in Early-stage TNBC · Phase 3 · recruiting
NCT06534762 — Milaberon in Advanced Solid Tumors: an Open, Multicenter Clinical Study · Phase 2 · recruiting

Other G1 Therapeutics, Inc. trials

Trials by the same sponsor.

NCT05112536 — Trilaciclib, a CDK4/6 Inhibitor, in Patients With Early-Stage Triple Negative Breast Cancer · Phase 2 · completed
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
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

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04799249 (US National Library of Medicine, public domain)
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: 1 August 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/NCT04799249.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing