Breast Cancer Clinical Trial
Trilaciclib, a CDK 4/6 Inhibitor, in Patients Receiving Gemcitabine and Carboplatin for Metastatic Triple-Negative Breast Cancer (TNBC)
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.
Full Description
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.
Eligibility Criteria
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 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
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
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There are 101 Locations for this study
Birmingham Alabama, 35235, United States More Info
Principal Investigator
Chandler Arizona, 85224, United States More Info
Principal Investigator
Gilbert Arizona, 85234, United States More Info
Principal Investigator
Santa Barbara California, 93105, United States More Info
Principal Investigator
Washington District of Columbia, 20010, United States More Info
Principal Investigator
Saint Petersburg Florida, 33705, United States More Info
Principal Investigator
Tampa Florida, 33612, United States More Info
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Niles Illinois, 60005, United States More Info
Principal Investigator
Baltimore Maryland, 21021, United States More Info
Principal Investigator
Clinton Maryland, 20735, United States More Info
Principal Investigator
Kansas City Missouri, 64111, United States More Info
Principal Investigator
Las Vegas Nevada, 89128, United States More Info
Principal Investigator
Charlotte North Carolina, 28204, United States More Info
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Durham North Carolina, 27710, United States More Info
Principal Investigator
Portland Oregon, 97225, United States More Info
Principal Investigator
Pittsburgh Pennsylvania, 15232, United States More Info
Principal Investigator
Willow Grove Pennsylvania, 19090, United States More Info
Principal Investigator
Chattanooga Tennessee, 37404, United States More Info
Principal Investigator
Memphis Tennessee, 38120, United States More Info
Principal Investigator
Nashville Tennessee, 37203, United States More Info
Principal Investigator
Austin Texas, 78731, United States More Info
Principal Investigator
Dallas Texas, 75231, United States More Info
Principal Investigator
Dallas Texas, 75246, United States More Info
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El Paso Texas, 79912, United States More Info
Principal Investigator
Houston Texas, 77024, United States More Info
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Houston Texas, 77070, United States More Info
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Irving Texas, 75063, United States More Info
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Tyler Texas, 75702, United States More Info
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Fairfax Virginia, 22031, United States More Info
Principal Investigator
Norfolk Virginia, 23502, United States More Info
Principal Investigator
Camperdown New South Wales, 2050, Australia More Info
Principal Investigator
Birtinya Queensland, 4575, Australia More Info
Principal Investigator
East Melbourne Victoria, 08006, Australia More Info
Principal Investigator
Malvern Victoria, 3144, Australia More Info
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North Sydney , 2060, Australia More Info
Principal Investigator
Burgas , 8000, Bulgaria More Info
Principal Investigator
Gabrovo , 5300, Bulgaria More Info
Principal Investigator
Sofia , 1330, Bulgaria More Info
Principal Investigator
Sofia , 1407, Bulgaria More Info
Principal Investigator
Hefei Anhui, 23000, China More Info
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Chaoyang Beijing, 10002, China More Info
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Yuzhong Chongqing, 40112, China More Info
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Yuexiu Guangzhou, 51006, China More Info
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Shijiazhuang Hebei, 05001, China More Info
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Harbin Heilongjiang, 15008, China More Info
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Zhengzhou Henan, 45005, China More Info
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Nanjing Jiangsu, 21000, China More Info
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Changchun Jilin, 13002, China More Info
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Changchun Jilin, 13002, China More Info
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Tianjin Tianjin, 30006, China More Info
Principal Investigator
Hangzhou Zhejiang, 31002, China More Info
Principal Investigator
Shanghai , 45005, China More Info
Principal Investigator
Caen Europe, 14000, France More Info
Principal Investigator
Le Mans Europe, 72000, France More Info
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Poitiers Europe, 86000, France More Info
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Villejuif Europe, 94800, France More Info
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Montpellier , 34298, France More Info
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Nantes , 44000, France More Info
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Toulouse , 31100, France More Info
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Batumi Ajaria, 6010', Georgia More Info
Principal Investigator
Batumi Ajaria, 6010, Georgia More Info
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Tbilisi , 0112, Georgia More Info
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Tbilisi , 0112, Georgia More Info
Principal Investigator
Tbilisi , 0112, Georgia More Info
Principal Investigator
Tbilisi , 0114, Georgia More Info
Principal Investigator
Tbilisi , 0159, Georgia More Info
Principal Investigator
Tbilisi , 0179, Georgia More Info
Principal Investigator
Tbilisi , 0186, Georgia More Info
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Tbilisi , 0186, Georgia More Info
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Tbilisi , 0186, Georgia More Info
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Tbilisi , 159, Georgia More Info
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Chisinau , MD-20, Moldova, Republic of More Info
Principal Investigator
Krakow Malopolskie, 30-51, Poland More Info
Principal Investigator
Poznan Wielkopolskie, 60-56, Poland More Info
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Lodz , 93-51, Poland More Info
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Skorzewo , 60-18, Poland More Info
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Warszawa , 02-78, Poland More Info
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Wroclaw , 51-12, Poland More Info
Principal Investigator
Åódź , 90-30, Poland More Info
Principal Investigator
Moscow Balashikha, 14390, Russian Federation More Info
Principal Investigator
Moscow Krasnogorsk, 14342, Russian Federation More Info
Principal Investigator
Moscow Vsevolozhsky, 18866, Russian Federation More Info
Principal Investigator
Kazan , 42002, Russian Federation More Info
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Moscow , 11799, Russian Federation More Info
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Moscow , 12146, Russian Federation More Info
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Moscow , 14390, Russian Federation More Info
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Saint-Petersburg, , 19711, Russian Federation More Info
Principal Investigator
Belgrade , 11000, Serbia More Info
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Belgrade , 11000, Serbia More Info
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Belgrade , 11000, Serbia More Info
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Nis , 18000, Serbia More Info
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Sremska Kamenica , 21204, Serbia More Info
Principal Investigator
Elche Alicante, 03203, Spain More Info
Principal Investigator
Sevilla AndalucÃa, 41013, Spain More Info
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Madrid Majadahonda, 28222, Spain More Info
Principal Investigator
Badajoz , 06006, Spain More Info
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Barcelona , 08035, Spain More Info
Principal Investigator
Barcelona , 08035, Spain More Info
Principal Investigator
Barcelona , 08036, Spain More Info
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Barcelona , 08190, Spain More Info
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Madrid , 28034, Spain More Info
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Palma de Mallorca , 07120, Spain More Info
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Sevilla , 41009, Spain More Info
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Kryvyi Rih Dnipropetrovska, 50048, Ukraine More Info
Principal Investigator
Kapitanivka Kyivska Oblast, 08112, Ukraine More Info
Principal Investigator
Sumy Sums'ka Oblast, 40022, Ukraine More Info
Principal Investigator
Ternopil Ternopil's'ka Oblast, 46023, Ukraine More Info
Principal Investigator
Vinnytsia Vinnyts'ka Oblast, 21029, Ukraine More Info
Principal Investigator
Lutsk Volyns'ka Oblast, 63000, Ukraine More Info
Principal Investigator
Zaporizhzhia , 69040, Ukraine More Info
Principal Investigator
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