Trilaciclib, a CDK 4/6 Inhibitor, in Patients Receiving Gemcitabine and Carboplatin for Metastatic Triple-Negative Breast Cancer (TNBC) (PRESERVE 2)

  • End date
    Oct 25, 2024
  • participants needed
  • sponsor
    G1 Therapeutics, Inc.
Updated on 4 October 2022
triple negative breast cancer
progesterone receptor


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.


This study will have two separate cohorts (Cohort 1 and Cohort 2). Both cohorts will follow the same general study conduct/design with similar primary and key secondary endpoints and identical treatment arms.

  • Cohort 1 will evaluate patients receiving first-line therapy, regardless of programmed death-ligand 1 (PD-L1) status, who are programmed cell death protein 1 (PD-1)/PD-L1 inhibitor therapy naïve.
  • Cohort 2 will evaluate PD-L1 positive patients receiving second-line therapy following prior PD-1/PD-L1 inhibitor therapy in the locally advanced unresectable/metastatic setting.

Condition TNBC - Triple-Negative Breast Cancer, Breast Cancer
Treatment carboplatin, Placebo, Gemcitabine, Trilaciclib
Clinical Study IdentifierNCT04799249
SponsorG1 Therapeutics, Inc.
Last Modified on4 October 2022


Yes No Not Sure

Inclusion Criteria

Age >/= 18 years of age with evaluable locally advanced unresectable or metastatic TNBC
Documentation of triple negative breast cancer (estrogen and progesterone receptor <1% and HER2-negative)
Prior systemic therapies (Cohort 1 only)
No prior systemic therapy in the locally advanced unresectable/metastatic setting including chemotherapy, targeted therapy, immunotherapy, or investigational agents
Prior PD-1/PD-L1 inhibitor treatment is not permitted in any setting, including in the neoadjuvant setting
Time between completion of last treatment with curative intent and first metastatic recurrence must be ≥ 6 months
Prior systemic therapies (Cohort 2 only)
Documentation of PD-L1 positive status
Treated with a PD-1/PD-L1 inhibitor for a minimum duration of 4 months in the locally advanced unresectable/metastatic setting and as the most recent therapy
Radiation therapy for metastatic disease is permitted. There is no required minimum
Archival tumor tissue must be available or a fresh biopsy must be obtained, unless approved by the Medical Monitor
washout period for radiation therapy. Patients should be recovered from the
effects of radiation
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Adequate organ function as demonstrated by normal laboratory values

Exclusion Criteria

Prior treatment with gemcitabine in any setting
Prior treatment with carboplatin in the locally advanced unresectable/metastatic setting
Prior carboplatin in the (neo)adjuvant/curative setting is permitted as long
as it was completed ≥ 6 months prior to the first metastatic recurrence
Presence of central nervous system (CNS) metastases and/or leptomeningeal disease requiring immediate treatment with radiation therapy or steroids
Receipt of any cytotoxic chemotherapy within 14 days prior to the first dose of study drugs
QTcF interval >480 msec at Screening (confirmed in triplicate). For patients with ventricular pacemakers, QTcF >500 msec
Known hypersensitivity to carboplatin or other platinum-containing compounds, or mannitol
Pregnant or lactating women
Prior hematopoietic stem cell or bone marrow transplantation
Clear my responses

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