Trilaciclib, a CDK 4/6 Inhibitor, in Patients Receiving Gemcitabine and Carboplatin for Metastati… (NCT04799249) | Clinical Trial Compass
CompletedPhase 3
Trilaciclib, a CDK 4/6 Inhibitor, in Patients Receiving Gemcitabine and Carboplatin for Metastatic Triple-Negative Breast Cancer (TNBC)
United States194 participantsStarted 2021-05-14
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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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
Exclusion criteria
✕. Prior treatment with gemcitabine in any setting.
✕. Prior treatment with carboplatin in the locally advanced unresectable/metastatic setting.
✕. 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.
What they're measuring
1
Effect on Overall Survival (OS)
Timeframe: Cohort 1:From date of randomization up to 39 months
2
Effect on Overall Survival (OS)
Timeframe: Cohort 2: From date of randomization up to 28 months