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

Primary Purpose

TNBC - Triple-Negative Breast Cancer, Breast Cancer

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Trilaciclib
Placebo
Gemcitabine
Carboplatin
Sponsored by
G1 Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for TNBC - Triple-Negative Breast Cancer focused on measuring breast cancer, gemcitabine, carboplatin, solid tumors, breast, chemotherapy, TNBC, trilaciclib, cyclin-dependent kinase 4/6 inhibitor, CDK 4/6 Inhibitor, triple-negative breast cancer, metastatic, chemotherapy-induced fatigue, HER2-negative, immunotherapy, immune checkpoint inhibitor therapy, chemotherapy-induced myelosuppression, myeloprotection, myeloprotective, PD-1/PD-L1 inhibitor therapy, advanced, stage 4, preserve, PRESERVE 2

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Age >/= 18 years of age with evaluable locally advanced unresectable or metastatic TNBC.
  2. Documentation of triple negative breast cancer (estrogen and progesterone receptor <1% and HER2-negative)

  3. Prior systemic therapies (Cohort 1 only):

    1. No prior systemic therapy in the locally advanced unresectable/metastatic setting including chemotherapy, targeted therapy, immunotherapy, or investigational agents.
    2. Prior PD-1/PD-L1 inhibitor treatment is not permitted in any setting, including in the neoadjuvant setting.
    3. Time between completion of last treatment with curative intent and first metastatic recurrence must be ≥ 6 months.

  4. Prior systemic therapies (Cohort 2 only):

    1. Documentation of PD-L1 positive status
    2. 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.
  5. 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.
  6. Archival tumor tissue must be available or a fresh biopsy must be obtained, unless approved by the Medical Monitor.
  7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  8. Adequate organ function as demonstrated by normal laboratory values

Exclusion Criteria:

  1. Prior treatment with gemcitabine in any setting.

  2. 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.

  3. Presence of central nervous system (CNS) metastases and/or leptomeningeal disease requiring immediate treatment with radiation therapy or steroids.
  4. Receipt of any cytotoxic chemotherapy within 14 days prior to the first dose of study drugs.
  5. QTcF interval >480 msec at Screening (confirmed in triplicate). For patients with ventricular pacemakers, QTcF >500 msec.
  6. Known hypersensitivity to carboplatin or other platinum-containing compounds, or mannitol
  7. Pregnant or lactating women
  8. Prior hematopoietic stem cell or bone marrow transplantation

Sites / Locations

  • Banner M.D. Anderson Cancer Center
  • Washington Cancer Institute at MedStar Washington Hospital Center - Oncology Research
  • Florida Cancer Specialists - North (SCRI)
  • Moffitt Cancer Center
  • Maryland Oncology Hematology, P.A.
  • Saint Luke's Cancer Specialists
  • Comprehensive Cancer Genetics of Nevada
  • Duke Cancer Center
  • UPC Pinnacle Health Cancer Institute
  • Tennessee Oncology Chattanooga
  • Baptist Cancer Cancer - Oncology
  • Tennessee Oncology (SCRI)
  • Texas Oncology- Austin Central
  • Texas Oncology - Baylor Charles A. Sammons Cancer Center
  • Texas Oncology P.A.
  • Virginia Oncology Associates
  • Chris O'Brien Lifehouse
  • Sunshine Coast University Hospital
  • Peter MacCallum Cancer Centre - Oncology
  • Cabrini Health
  • Mater Hospital Sydney
  • Complex Oncology Center - Burgas
  • Medical Ctr Nadezhda Clinical
  • The First Affiliated Hospital of Chongqing Medical University
  • Sun Yat-sen University Cancer Center
  • The Fourth Hospital of Hebei Medical University
  • Anhui Provincial Hospital
  • First Affiliated Hospital of Zhengzhou University
  • Jilin Cancer Hospital
  • The First Hospital of Jilin University
  • Tianjin Cancer Hospital
  • Zhejiang Cancer Hospital
  • Fudan University Shanghai Cancer Center
  • Centre Jean Bernard
  • Centre Francois Baclesse
  • ICM-Val d'Aurelle
  • Centre Hospitalier de Poitiers
  • Pharmacie Essais Cliniques
  • Centre Leon Berard
  • High Technology Hospital MedCenter LTD
  • Acad.Fridon Todua Medical Center - Research Institute of Clinical Medicine
  • ARENSIA Exploratory Medicine Harmony Health
  • LTD Israeli-Georgian Medical Research Clinic Helsicore
  • LTD Multiprofile Clinic Consilium Medulla
  • TIM - Tbilisi Institute of Medicine LTD
  • Institute Of Clinical Oncology LTD
  • IMSP Institutul Oncologic, ARENSIA Exploratory Medicine
  • Pratia MCM Krakow
  • Med-Polonia Sp. Z o.o.
  • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi, Oddzial Chorob Rozrostowych
  • Centrum Medyczne Pratia Poznan
  • Narodowy Instytut Onkologii im. Marii Sklodowskiej - Curie - Panstwowy Instytut Badawczy
  • Instytut MSF Sp. z. o.o.
  • Saint-Petersburg State Budgetary Healthcare Institution "City Clinical Oncology Dispensary"
  • SAHI Republcx Clinical Oncology Dispensary of the Ministry of Healthcare of Tatarstan Republix
  • FSBI Russian Scientific Center of Roentgenoradiology of the MoH of Russia
  • State Budgetary Healthcare Institution of Moscow Region "Moscow Reginoal Oncology Dispensary"
  • Budgetary Healthcare Institution of Omsk Region "Clinical Oncological Dispensary"
  • Hospital General Universitario de Elche
  • Hospital Puerta de Hierro Majadahonda
  • Hospital Universitario de Badajos
  • Hospital Universitario 12 de Octubre
  • Vall d'Hebrón University Hospital
  • Hospital Clìnic de Barcelona
  • Hospital Universitario Ramón y Cajal
  • Yuri Prokopovich Spizhenko
  • Komunalne nekomertsiine pidpryiemstvo Sumskoi oblasnoi rady Sumskyi oblasnyi onkolohichnyi dyspanser
  • Komunalne nekomertsiine pidpryiemstvo Ternopilskyi oblasnyi klinichnyi onkolohichnyi dyspanser Ternopilskoi oblasnoi rady
  • Volynskyi oblasnyi medychnyi tsentr onkolohii
  • Komunalne nekomertsiine pidpryiemstvo Miska klinichna likarnia No 4 Dniprovskoi miskoi rady

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Trilaciclib + gemcitabine + carboplatin

Placebo + gemcitabine + carboplatin

Arm Description

Trilaciclib (240mg/m2) + gemcitabine (1000 mg/m2) and carboplatin (AUC 2)

The subjects in the placebo arm will follow the same schedule as the trilaciclib arm, but will receive placebo instead of trilaciclib.

Outcomes

Primary Outcome Measures

Effect on Overall Survival (OS)
(Cohort 1):To evaluate the effect of trilaciclib on overall survival (OS) compared with placebo in patients receiving first-line gemcitabine and carboplatin.
Effect on Overall Survival (OS)
(Cohort 2): To evaluate the effect of trilaciclib on OS compared with placebo in patients receiving gemcitabine and carboplatin as second-line therapy after treatment with a PD-1/PD-L1 inhibitor in the locally advanced unresectable/metastatic setting

Secondary Outcome Measures

Quality of life/Effects On Chemotherapy-Induced Fatigue
To assess the effect of trilaciclib on patients' quality of life as measured by time to first confirmed deterioration of fatigue compared with placebo in patients receiving gemcitabine and carboplatin
Myeloprotective Effects
Occurrence of cytopenias, febrile neutropenia, hospitalization due to chemotherapy-induced myelosuppression, RBC and platelet transfusions, growth factor administration, and dose reductions and delays
Progression Free Survival
To evaluate the effect of trilaciclib on progression-free survival (PFS) compared with placebo in patients receiving gemcitabine and carboplatin.

Full Information

First Posted
February 18, 2021
Last Updated
May 1, 2023
Sponsor
G1 Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04799249
Brief Title
Trilaciclib, a CDK 4/6 Inhibitor, in Patients Receiving Gemcitabine and Carboplatin for Metastatic Triple-Negative Breast Cancer (TNBC)
Acronym
PRESERVE 2
Official Title
A Phase 3, Randomized, Double-Blind Study of Trilaciclib or Placebo in Patients Receiving First- or Second-Line Gemcitabine and Carboplatin Chemotherapy for Locally Advanced Unresectable or Metastatic Triple-Negative Breast Cancer (PRESERVE 2)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 15, 2021 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
October 25, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
G1 Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
TNBC - Triple-Negative Breast Cancer, Breast Cancer
Keywords
breast cancer, gemcitabine, carboplatin, solid tumors, breast, chemotherapy, TNBC, trilaciclib, cyclin-dependent kinase 4/6 inhibitor, CDK 4/6 Inhibitor, triple-negative breast cancer, metastatic, chemotherapy-induced fatigue, HER2-negative, immunotherapy, immune checkpoint inhibitor therapy, chemotherapy-induced myelosuppression, myeloprotection, myeloprotective, PD-1/PD-L1 inhibitor therapy, advanced, stage 4, preserve, PRESERVE 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
Double-Blind Trial
Allocation
Randomized
Enrollment
194 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Trilaciclib + gemcitabine + carboplatin
Arm Type
Experimental
Arm Description
Trilaciclib (240mg/m2) + gemcitabine (1000 mg/m2) and carboplatin (AUC 2)
Arm Title
Placebo + gemcitabine + carboplatin
Arm Type
Placebo Comparator
Arm Description
The subjects in the placebo arm will follow the same schedule as the trilaciclib arm, but will receive placebo instead of trilaciclib.
Intervention Type
Drug
Intervention Name(s)
Trilaciclib
Other Intervention Name(s)
G1T28, COSELA
Intervention Description
Trilaciclib administered IV over 30mins prior to chemotherapy on Day 1 and Day 8 of each 21-day cycle.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
0.9% normal saline, 5 % Dextrose in water (D5W)
Intervention Description
Placebo administered IV over 30mins prior to chemotherapy on Day 1 and Day 8 of each 21-day cycle.
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
Gemcitabine administered IV on Day 1 and Day 8 of each 21-day cycle.
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Carboplatin administered IV on Day 1 and Day 8 of each 21-day cycle.
Primary Outcome Measure Information:
Title
Effect on Overall Survival (OS)
Description
(Cohort 1):To evaluate the effect of trilaciclib on overall survival (OS) compared with placebo in patients receiving first-line gemcitabine and carboplatin.
Time Frame
Cohort 1:From date of randomization up to 39 months
Title
Effect on Overall Survival (OS)
Description
(Cohort 2): To evaluate the effect of trilaciclib on OS compared with placebo in patients receiving gemcitabine and carboplatin as second-line therapy after treatment with a PD-1/PD-L1 inhibitor in the locally advanced unresectable/metastatic setting
Time Frame
Cohort 2: From date of randomization up to 28 months
Secondary Outcome Measure Information:
Title
Quality of life/Effects On Chemotherapy-Induced Fatigue
Description
To assess the effect of trilaciclib on patients' quality of life as measured by time to first confirmed deterioration of fatigue compared with placebo in patients receiving gemcitabine and carboplatin
Time Frame
Cycle 1 Day 1 (each cycle is 21 days) up to 14 months
Title
Myeloprotective Effects
Description
Occurrence of cytopenias, febrile neutropenia, hospitalization due to chemotherapy-induced myelosuppression, RBC and platelet transfusions, growth factor administration, and dose reductions and delays
Time Frame
Cycle 1 Day 1 (each cycle is 21 days) up to 14 months
Title
Progression Free Survival
Description
To evaluate the effect of trilaciclib on progression-free survival (PFS) compared with placebo in patients receiving gemcitabine and carboplatin.
Time Frame
From date of randomization up to 14 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Contact
Organizational Affiliation
G1 Therapeutics, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Banner M.D. Anderson Cancer Center
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85234
Country
United States
Facility Name
Washington Cancer Institute at MedStar Washington Hospital Center - Oncology Research
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Florida Cancer Specialists - North (SCRI)
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Maryland Oncology Hematology, P.A.
City
Clinton
State/Province
Maryland
ZIP/Postal Code
20735
Country
United States
Facility Name
Saint Luke's Cancer Specialists
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Comprehensive Cancer Genetics of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Duke Cancer Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
UPC Pinnacle Health Cancer Institute
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Tennessee Oncology Chattanooga
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Baptist Cancer Cancer - Oncology
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Tennessee Oncology (SCRI)
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Texas Oncology- Austin Central
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Texas Oncology - Baylor Charles A. Sammons Cancer Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Texas Oncology P.A.
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
Facility Name
Virginia Oncology Associates
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Chris O'Brien Lifehouse
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Sunshine Coast University Hospital
City
Birtinya
State/Province
Queensland
ZIP/Postal Code
4575
Country
Australia
Facility Name
Peter MacCallum Cancer Centre - Oncology
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
08006
Country
Australia
Facility Name
Cabrini Health
City
Malvern
State/Province
Victoria
ZIP/Postal Code
3144
Country
Australia
Facility Name
Mater Hospital Sydney
City
North Sydney
ZIP/Postal Code
2060
Country
Australia
Facility Name
Complex Oncology Center - Burgas
City
Burgas
ZIP/Postal Code
8000
Country
Bulgaria
Facility Name
Medical Ctr Nadezhda Clinical
City
Sofia
ZIP/Postal Code
1330
Country
Bulgaria
Facility Name
The First Affiliated Hospital of Chongqing Medical University
City
Yuzhong
State/Province
Chongqing
ZIP/Postal Code
401122
Country
China
Facility Name
Sun Yat-sen University Cancer Center
City
Yuexiu
State/Province
Guangzhou
ZIP/Postal Code
510060
Country
China
Facility Name
The Fourth Hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050011
Country
China
Facility Name
Anhui Provincial Hospital
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150081
Country
China
Facility Name
First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450052
Country
China
Facility Name
Jilin Cancer Hospital
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Facility Name
The First Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Facility Name
Tianjin Cancer Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
ZIP/Postal Code
450052
Country
China
Facility Name
Centre Jean Bernard
City
Le Mans
State/Province
Europe
ZIP/Postal Code
72000
Country
France
Facility Name
Centre Francois Baclesse
City
Caen
ZIP/Postal Code
14000
Country
France
Facility Name
ICM-Val d'Aurelle
City
Montpellier
ZIP/Postal Code
34298
Country
France
Facility Name
Centre Hospitalier de Poitiers
City
Poitiers
ZIP/Postal Code
86000
Country
France
Facility Name
Pharmacie Essais Cliniques
City
Toulouse
ZIP/Postal Code
31100
Country
France
Facility Name
Centre Leon Berard
City
Villejuif
ZIP/Postal Code
94800
Country
France
Facility Name
High Technology Hospital MedCenter LTD
City
Batumi
State/Province
Ajaria
ZIP/Postal Code
6010
Country
Georgia
Facility Name
Acad.Fridon Todua Medical Center - Research Institute of Clinical Medicine
City
Tbilisi
ZIP/Postal Code
0112
Country
Georgia
Facility Name
ARENSIA Exploratory Medicine Harmony Health
City
Tbilisi
ZIP/Postal Code
0112
Country
Georgia
Facility Name
LTD Israeli-Georgian Medical Research Clinic Helsicore
City
Tbilisi
ZIP/Postal Code
0112
Country
Georgia
Facility Name
LTD Multiprofile Clinic Consilium Medulla
City
Tbilisi
ZIP/Postal Code
0186
Country
Georgia
Facility Name
TIM - Tbilisi Institute of Medicine LTD
City
Tbilisi
ZIP/Postal Code
0186
Country
Georgia
Facility Name
Institute Of Clinical Oncology LTD
City
Tbilisi
ZIP/Postal Code
159
Country
Georgia
Facility Name
IMSP Institutul Oncologic, ARENSIA Exploratory Medicine
City
Chisinau
ZIP/Postal Code
MD-2025
Country
Moldova, Republic of
Facility Name
Pratia MCM Krakow
City
Krakow
State/Province
Malopolskie
ZIP/Postal Code
30-510
Country
Poland
Facility Name
Med-Polonia Sp. Z o.o.
City
Poznan
State/Province
Wielkopolskie
ZIP/Postal Code
60-569
Country
Poland
Facility Name
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi, Oddzial Chorob Rozrostowych
City
Lodz
ZIP/Postal Code
93-513
Country
Poland
Facility Name
Centrum Medyczne Pratia Poznan
City
Skorzewo
ZIP/Postal Code
60-185
Country
Poland
Facility Name
Narodowy Instytut Onkologii im. Marii Sklodowskiej - Curie - Panstwowy Instytut Badawczy
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Instytut MSF Sp. z. o.o.
City
Łódź
ZIP/Postal Code
90-302
Country
Poland
Facility Name
Saint-Petersburg State Budgetary Healthcare Institution "City Clinical Oncology Dispensary"
City
Moscow
State/Province
Balashikha
ZIP/Postal Code
143900
Country
Russian Federation
Facility Name
SAHI Republcx Clinical Oncology Dispensary of the Ministry of Healthcare of Tatarstan Republix
City
Kazan
ZIP/Postal Code
420029
Country
Russian Federation
Facility Name
FSBI Russian Scientific Center of Roentgenoradiology of the MoH of Russia
City
Moscow
ZIP/Postal Code
117997
Country
Russian Federation
Facility Name
State Budgetary Healthcare Institution of Moscow Region "Moscow Reginoal Oncology Dispensary"
City
Moscow
ZIP/Postal Code
143900
Country
Russian Federation
Facility Name
Budgetary Healthcare Institution of Omsk Region "Clinical Oncological Dispensary"
City
Omsk
ZIP/Postal Code
644013
Country
Russian Federation
Facility Name
Hospital General Universitario de Elche
City
Elche
State/Province
Alicante
ZIP/Postal Code
03203
Country
Spain
Facility Name
Hospital Puerta de Hierro Majadahonda
City
Madrid
State/Province
Majadahonda
ZIP/Postal Code
28222
Country
Spain
Facility Name
Hospital Universitario de Badajos
City
Badajoz
ZIP/Postal Code
06006
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Vall d'Hebrón University Hospital
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clìnic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Universitario Ramón y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Yuri Prokopovich Spizhenko
City
Kapitanivka
State/Province
Kyivska Oblast
ZIP/Postal Code
08112
Country
Ukraine
Facility Name
Komunalne nekomertsiine pidpryiemstvo Sumskoi oblasnoi rady Sumskyi oblasnyi onkolohichnyi dyspanser
City
Sumy
State/Province
Sums'ka Oblast
ZIP/Postal Code
40022
Country
Ukraine
Facility Name
Komunalne nekomertsiine pidpryiemstvo Ternopilskyi oblasnyi klinichnyi onkolohichnyi dyspanser Ternopilskoi oblasnoi rady
City
Ternopil
State/Province
Ternopil's'ka Oblast
ZIP/Postal Code
46023
Country
Ukraine
Facility Name
Volynskyi oblasnyi medychnyi tsentr onkolohii
City
Lutsk
State/Province
Volyns'ka Oblast
ZIP/Postal Code
63000
Country
Ukraine
Facility Name
Komunalne nekomertsiine pidpryiemstvo Miska klinichna likarnia No 4 Dniprovskoi miskoi rady
City
Dnipro
ZIP/Postal Code
49102
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
36135712
Citation
Goel S, Tan AR, Rugo HS, Aftimos P, Andric Z, Beelen A, Zhang J, Yi JS, Malik R, O'Shaughnessy J. Trilaciclib prior to gemcitabine plus carboplatin for metastatic triple-negative breast cancer: phase III PRESERVE 2. Future Oncol. 2022 Oct;18(33):3701-3711. doi: 10.2217/fon-2022-0773. Epub 2022 Sep 22.
Results Reference
derived

Learn more about this trial

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

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