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

Completed · Phase 3 · Has a placebo group

Conditions studied: TNBC - Triple-Negative Breast Cancer, Breast Cancer

In brief

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.

Key facts

Study ID

NCT04799249

Run by

G1 Therapeutics, Inc.

People needed

194

Starts

2021-05-14

Expected to finish

2024-05-24

Last updated by the study team

2024-08-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 washout period for radiation therapy. Patients should be recovered from the effects of radiation.
• Archival tumor tissue must be available or a fresh biopsy must be obtained, unless approved by the Medical Monitor.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Adequate organ function as demonstrated by normal laboratory values

You may not qualify if…

• 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

Where it is running

• Washington Cancer Institute at MedStar Washington Hospital Center - Oncology Research — Washington D.C., District of Columbia, United States
• Florida Cancer Specialists - North (SCRI) — St. Petersburg, Florida, United States
• Moffitt Cancer Center — Tampa, Florida, United States
• Maryland Oncology Hematology, P.A. — Clinton, Maryland, United States
• Saint Luke's Cancer Specialists — Kansas City, Missouri, United States
• Comprehensive Cancer Genetics of Nevada — Las Vegas, Nevada, United States
• Duke Cancer Center — Durham, North Carolina, United States
• UPC Pinnacle Health Cancer Institute — Pittsburgh, Pennsylvania, United States
• Tennessee Oncology Chattanooga — Chattanooga, Tennessee, United States
• Baptist Cancer Cancer - Oncology — Memphis, Tennessee, United States
• Tennessee Oncology (SCRI) — Nashville, Tennessee, United States
• Texas Oncology- Austin Central — Austin, Texas, United States
• Texas Oncology - Baylor Charles A. Sammons Cancer Center — Dallas, Texas, United States
• Texas Oncology P.A. — Tyler, Texas, United States
• Virginia Oncology Associates — Norfolk, Virginia, United States
• Chris O'Brien Lifehouse — Camperdown, New South Wales, Australia
• Sunshine Coast University Hospital — Birtinya, Queensland, Australia
• Peter MacCallum Cancer Centre - Oncology — East Melbourne, Victoria, Australia
• Cabrini Health — Malvern, Victoria, Australia
• Mater Hospital Sydney — North Sydney, Australia
• Complex Oncology Center - Burgas — Burgas, Bulgaria
• Medical Ctr Nadezhda Clinical — Sofia, Bulgaria
• Cancer Hospital Chinese Academy of Medical Sciences — Chaoyang, Beijing Municipality, China
• The First Affiliated Hospital of Chongqing Medical University — Yuzhong, Chongqing Municipality, China
• Banner M.D. Anderson Cancer Center — Gilbert, Arizona, United States

Full record on ClinicalTrials.gov

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