xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06027268</url>
    </required_header>
    <id_info>
      <org_study_id>IRB00095334</org_study_id>
      <secondary_id>LCI-BRE-MTN-TPGC-001</secondary_id>
      <nct_id>NCT06027268</nct_id>
    </id_info>
    <brief_title>Phase II Trial of Trilaciclib, Pembrolizumab, Gemcitabine and Carboplatin in Metastatic Triple-Negative Breast Cancer</brief_title>
    <acronym>ToPCourT</acronym>
    <official_title>ToPCourT: A Phase II Trial of Trilaciclib, Pembrolizumab, Gemcitabine and Carboplatin in Locally Advanced Unresectable or Metastatic Triple-Negative Breast Cancer (TNBC)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Wake Forest University Health Sciences</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Merck Sharp &amp; Dohme LLC</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
      <collaborator>
        <agency>G1 Therapeutics, Inc.</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Wake Forest University Health Sciences</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this phase II study is to test the combination of trilaciclib, pembrolizumab,&#xD;
        gemcitabine, and carboplatin in locally advanced unresectable or metastatic triple-negative&#xD;
        breast cancer.&#xD;
  &#xD;
        The main questions it aims to answer are:&#xD;
  &#xD;
          -  to evaluate the anti-cancer efficacy (assess how well it works)&#xD;
  &#xD;
          -  to evaluate the safety and tolerability (how well the body can handle the treatment) of&#xD;
             this combination of anti-cancer therapy&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is an open label, single-arm, phase II trial designed to evaluate the efficacy of&#xD;
        trilaciclib, pembrolizumab, gemcitabine and carboplatin in participants with locally advanced&#xD;
        unresectable or metastatic triple-negative breast cancer. Pembrolizumab will be given for a&#xD;
        maximum of 2 years. Eligible participants will receive the study treatment until disease&#xD;
        progression, unacceptable toxicity, or withdrawal for any reason. A tumor biopsy will be&#xD;
        collected from participants in which it can be safely obtained before the first dose of&#xD;
        treatment, prior to Cycle 3 Day 1, and at the time of disease progression (optional). Blood&#xD;
        specimens for correlative studies will be collected pre-treatment Cycle 1 Day 1, prior to&#xD;
        treatment Cycle 2 Day 1, prior to treatment Cycle 3 Day 1, 3 months after the start of study&#xD;
        treatment, and 6 months after the start of study treatment.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">March 2027</completion_date>
    <primary_completion_date type="Anticipated">September 2026</primary_completion_date>
    <phase>Phase 2</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Objective Response</measure>
      <time_frame>6 months (initiation of protocol directed therapy until either a partial response is achieved or treatment discontinuation)</time_frame>
      <description>Objective according to RECIST v1.1 criteria</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Progression-free survival</measure>
      <time_frame>1 year (initiation of protocol directed therapy until documented disease progression, death, or end of follow-up period)</time_frame>
      <description>Time to disease progression per RECIST v1.1 criteria or death</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of response</measure>
      <time_frame>1 year (time from first disease assessment that shows a PR or complete response (CR) until documented disease progression, death, or end of follow-up period)</time_frame>
      <description>Duration of response will be calculated only for subjects who achieve an objective response according to RECIST v1.1 criteria (a CR or PR). Disease progression will be objectively determined as per RECIST 1.1 criteria or progression can be subjective as determined by the Investigator.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall survival</measure>
      <time_frame>1 year (initiation of protocol directed therapy until documented death, or end of follow-up period])</time_frame>
      <description>Time to date of death due to any cause while on study</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">36</enrollment>
    <condition>Metastatic Triple-Negative Breast Cancer</condition>
    <arm_group>
      <arm_group_label>Trilaciclib, Pembrolizumab, Gemcitabine, and Carboplatin</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Trilaciclib is an agent that helps protect the bone marrow from the side effects of chemotherapy. It is given as an intravenous (IV) infusion over 30 minutes prior to gemcitabine and carboplatin. Gemcitabine is given IV over 30 minutes. Carboplatin is given over 30 minutes. Trilaciclib, gemcitabine and carboplatin are given on Days 1 and 8 every 21 days. Pembrolizumab is given IV over 30 minutes on Day 1 every 21 days.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Trilaciclib</intervention_name>
      <description>IV infusion Day 1 and Day 8 every 21 days, at dose of 240 mg/m2</description>
      <arm_group_label>Trilaciclib, Pembrolizumab, Gemcitabine, and Carboplatin</arm_group_label>
      <other_name>COSELA</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Pembrolizumab</intervention_name>
      <description>IV infusion Day 1 every 21 days, at dose of 200 mg</description>
      <arm_group_label>Trilaciclib, Pembrolizumab, Gemcitabine, and Carboplatin</arm_group_label>
      <other_name>KEYTRUDA</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Gemcitabine</intervention_name>
      <description>IV infusion Day 1 and Day 8 every 21 days, at dose 1000 mg/m2</description>
      <arm_group_label>Trilaciclib, Pembrolizumab, Gemcitabine, and Carboplatin</arm_group_label>
      <other_name>Gemzar</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Carboplatin</intervention_name>
      <description>IV infusion Day 1 and Day 8 every 21 days, at dose area under curve (AUC) 2 (maximum of 300 mg)</description>
      <arm_group_label>Trilaciclib, Pembrolizumab, Gemcitabine, and Carboplatin</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Written informed consent and HIPAA authorization for release of personal health&#xD;
               information signed by the patient&#xD;
  &#xD;
            2. Male or female with locally advanced unresectable or metastatic TNBC&#xD;
  &#xD;
            3. Age ≥ 18 years at the time of consent&#xD;
  &#xD;
            4. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1 evaluated&#xD;
               within 28 days prior to day 1 of study treatment&#xD;
  &#xD;
            5. Histological or cytological confirmation of estrogen negative and progesterone&#xD;
               negative tumor, defined as &lt; 10% staining on immunohistochemistry (IHC) and human&#xD;
               epidermal growth factor receptor type 2 (HER2)-negative, defined as IHC 0 or 1+ or&#xD;
               fluorescence in-situ hybridization (FISH) HER2: chromosome enumeration probe 17 (CEP)&#xD;
               ratio &lt;2.0 with an average copy number of &lt;4 signals/nucleus per 2018 American Society&#xD;
               of Clinical Oncology and the College of American Pathologists (ASCO CAP) criteria.&#xD;
               Patients may be enrolled regardless of their PD-L1 (programmed death ligand-1) status.&#xD;
  &#xD;
            6. Measurable disease according to response evaluation criteria in solid tumors&#xD;
  &#xD;
            7. Demonstrate adequate organ function&#xD;
  &#xD;
            8. Female patients: All females of childbearing potential must have a negative serum&#xD;
               β-human chorionic gonadotropin (hCG) test result at Screening and negative serum or&#xD;
               urine pregnancy test results within 72 hours prior to day 1 of study treatment.&#xD;
  &#xD;
            9. Subject agrees to use contraception&#xD;
  &#xD;
           10. As determined by the enrolling physician, the ability of the subject to understand and&#xD;
               comply with study procedures for the entire length of the study&#xD;
  &#xD;
           11. Tumor tissue: Willing to provide tumor tissue for research purposes&#xD;
  &#xD;
           12. Subject has a life expectancy of ≥ 12 weeks&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. More than 3 prior lines of chemotherapy for locally advanced unresectable or&#xD;
               triple-negative metastatic disease&#xD;
  &#xD;
            2. Prior therapy with the concurrent combination of gemcitabine and carboplatin in the&#xD;
               metastatic setting&#xD;
  &#xD;
            3. Active, symptomatic central nervous system (CNS) metastases and/or carcinomatous&#xD;
               meningitis or CNS metastases that are progressing on screening magnetic resonance&#xD;
               imaging (MRI) brain.&#xD;
  &#xD;
            4. Prior systemic anti-cancer therapy within 3 weeks, prior stereotactic radiotherapy&#xD;
               within 1 week, and radiation within 2 weeks of day 1 of study treatment. Participants&#xD;
               must have recovered from all radiation-related toxicities, not require&#xD;
               corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted&#xD;
               for palliative radiation to non-CNS disease.&#xD;
  &#xD;
            5. Major surgery, defined by the investigator's discretion, within 3 weeks of day 1 of&#xD;
               study treatment&#xD;
  &#xD;
            6. Not recovered from all reversible acute toxic effects of prior therapy, including&#xD;
               non-hematologic toxicities related to prior systemic therapy to ≤ Grade 1.&#xD;
               Participants with less than Grade 2 neuropathy or alopecia of any grade are an&#xD;
               exception&#xD;
  &#xD;
            7. Active infection requiring systemic therapy&#xD;
  &#xD;
            8. Pregnant or breastfeeding&#xD;
  &#xD;
            9. Participants previously diagnosed with an additional malignancy must be disease-free&#xD;
               for at least five years prior to enrollment. Exceptions include basal cell or squamous&#xD;
               cell skin cancer and in situ cervical or bladder cancer.&#xD;
  &#xD;
           10. Treatment with any investigational drug within 30 days or at least 5 half-lives,&#xD;
               whichever is longer, prior to day 1 of study treatment&#xD;
  &#xD;
           11. Uncontrolled intercurrent illness including, but not limited to, ongoing or active&#xD;
               infection, uncontrolled symptomatic congestive heart failure (Class III or IV as&#xD;
               defined by the New York Heart Association (NYHA) functional classification system),&#xD;
               unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social&#xD;
               situations/substance abuse that would limit compliance with study requirements as&#xD;
               determined by the investigator&#xD;
  &#xD;
           12. Known history of stroke or cerebrovascular event within 6 months prior to the day 1 of&#xD;
               study treatment&#xD;
  &#xD;
           13. Known hypersensitivity to carboplatin or other platinum-containing compounds,&#xD;
               gemcitabine, mannitol, or pembrolizumab&#xD;
  &#xD;
           14. History of non-infectious interstitial lung disease (ILD)/pneumonitis that required&#xD;
               steroids or current ILD/ pneumonitis.&#xD;
  &#xD;
           15. Has active autoimmune disease that has required systemic treatment in the past 2 years&#xD;
               (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive&#xD;
               drugs) prior to day 1 of study treatment. Replacement therapy (e.g., thyroxine,&#xD;
               insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary&#xD;
               insufficiency, etc.) is not considered a form of systemic treatment and is allowed&#xD;
  &#xD;
           16. Prior hematopoietic stem cell or bone marrow transplant or allogenic tissue/solid&#xD;
               organ transplant&#xD;
  &#xD;
           17. Has a known history of Human Immunodeficiency Virus (HIV) or known acquired&#xD;
               immunodeficiency syndrome (AIDS)&#xD;
  &#xD;
           18. Has known active hepatitis B (e.g., hepatitis B surface antigen [HBsAg] reactive).&#xD;
  &#xD;
           19. Has known active hepatitis C (e.g., hepatitis C virus (HCV) ribonucleic acid (RNA)&#xD;
               [qualitative] is detected).&#xD;
  &#xD;
           20. Receipt of a live, attenuated vaccine within 30 days prior to day 1 of study treatment&#xD;
               or anticipation that such a live, attenuated vaccine will be required during the study&#xD;
               treatment period. Administration of killed vaccines is allowed. Exception: Monkeypox&#xD;
               vaccine may be given if there are at least 3 days between the vaccine and initiation&#xD;
               of study treatment.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Antoinette Tan, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Wake Forest University Health Sciences</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Leah Wilson</last_name>
      <phone>(980) 442-2333</phone>
      <email>leah.j.wilson@atriumhealth.org</email>
    </overall_contact>
    <location>
      <facility>
        <name>Levine Cancer Institute</name>
        <address>
          <city>Charlotte</city>
          <state>North Carolina</state>
          <zip>28204</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Leah Wilson</last_name>
        <phone>980-442-2333</phone>
        <email>leah.j.wilson@atriumhealth.org</email>
      </contact>
      <investigator>
        <last_name>Antoinette Tan, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <reference>
      <citation>Tan AR, Wright GS, Thummala AR, Danso MA, Popovic L, Pluard TJ, Han HS, Vojnovic Z, Vasev N, Ma L, Richards DA, Wilks ST, Milenkovic D, Yang Z, Antal JM, Morris SR, O'Shaughnessy J. Trilaciclib plus chemotherapy versus chemotherapy alone in patients with metastatic triple-negative breast cancer: a multicentre, randomised, open-label, phase 2 trial. Lancet Oncol. 2019 Nov;20(11):1587-1601. doi: 10.1016/S1470-2045(19)30616-3. Epub 2019 Sep 28.</citation>
      <PMID>31575503</PMID>
    </reference>
    <reference>
      <citation>Tan AR, Wright GS, Thummala AR, Danso MA, Popovic L, Pluard TJ, Han HS, Vojnovic Z, Vasev N, Ma L, Richards DA, Wilks ST, Milenkovic D, Xiao J, Sorrentino J, Horton J, O'Shaughnessy J. Trilaciclib Prior to Chemotherapy in Patients with Metastatic Triple-Negative Breast Cancer: Final Efficacy and Subgroup Analysis from a Randomized Phase II Study. Clin Cancer Res. 2022 Feb 15;28(4):629-636. doi: 10.1158/1078-0432.CCR-21-2272.</citation>
      <PMID>34887261</PMID>
    </reference>
    <reference>
      <citation>Tan AR, O'Shaughnessy J, Cao S, Ahn S, Yi JS. Investigating potential immune mechanisms of trilaciclib administered prior to chemotherapy in patients with metastatic triple-negative breast cancer. Breast Cancer Res Treat. 2023 Sep;201(2):307-316. doi: 10.1007/s10549-023-07009-8. Epub 2023 Jul 7.</citation>
      <PMID>37418031</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Breast-Female</keyword>
    <keyword>Breast-Male</keyword>
    <keyword>Triple-Negative Breast Cancer</keyword>
    <keyword>Metastatic</keyword>
    <keyword>Locally advanced unresectable</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Breast Neoplasms</mesh_term>
      <mesh_term>Triple Negative Breast Neoplasms</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Carboplatin</mesh_term>
      <mesh_term>Gemcitabine</mesh_term>
      <mesh_term>Pembrolizumab</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06027268
  org study id: IRB00095334
  secondary id: LCI-BRE-MTN-TPGC-001
  nct id: NCT06027268
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: No
  The goal of this phase II study is to test the combination of trilaciclib, pembrolizumab,
        gemcitabine, and carboplatin in locally advanced unresectable or metastatic triple-negative
        breast cancer.
  
        The main questions it aims to answer are:
  
          -  to evaluate the anti-cancer efficacy (assess how well it works)
  
          -  to evaluate the safety and tolerability (how well the body can handle the treatment) of
             this combination of anti-cancer therapy
  This is an open label, single-arm, phase II trial designed to evaluate the efficacy of
        trilaciclib, pembrolizumab, gemcitabine and carboplatin in participants with locally advanced
        unresectable or metastatic triple-negative breast cancer. Pembrolizumab will be given for a
        maximum of 2 years. Eligible participants will receive the study treatment until disease
        progression, unacceptable toxicity, or withdrawal for any reason. A tumor biopsy will be
        collected from participants in which it can be safely obtained before the first dose of
        treatment, prior to Cycle 3 Day 1, and at the time of disease progression (optional). Blood
        specimens for correlative studies will be collected pre-treatment Cycle 1 Day 1, prior to
        treatment Cycle 2 Day 1, prior to treatment Cycle 3 Day 1, 3 months after the start of study
        treatment, and 6 months after the start of study treatment.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Objective Response
  time frame: 6 months (initiation of protocol directed therapy until either a partial response is achieved or treatment discontinuation)
  description: Objective according to RECIST v1.1 criteria
  measure: Progression-free survival
  time frame: 1 year (initiation of protocol directed therapy until documented disease progression, death, or end of follow-up period)
  description: Time to disease progression per RECIST v1.1 criteria or death
  measure: Duration of response
  time frame: 1 year (time from first disease assessment that shows a PR or complete response (CR) until documented disease progression, death, or end of follow-up period)
  description: Duration of response will be calculated only for subjects who achieve an objective response according to RECIST v1.1 criteria (a CR or PR). Disease progression will be objectively determined as per RECIST 1.1 criteria or progression can be subjective as determined by the Investigator.
  measure: Overall survival
  time frame: 1 year (initiation of protocol directed therapy until documented death, or end of follow-up period])
  description: Time to date of death due to any cause while on study
  arm group label: Trilaciclib, Pembrolizumab, Gemcitabine, and Carboplatin
  arm group type: Experimental
  description: Trilaciclib is an agent that helps protect the bone marrow from the side effects of chemotherapy. It is given as an intravenous (IV) infusion over 30 minutes prior to gemcitabine and carboplatin. Gemcitabine is given IV over 30 minutes. Carboplatin is given over 30 minutes. Trilaciclib, gemcitabine and carboplatin are given on Days 1 and 8 every 21 days. Pembrolizumab is given IV over 30 minutes on Day 1 every 21 days.
  intervention type: Drug
  intervention name: Trilaciclib
  description: IV infusion Day 1 and Day 8 every 21 days, at dose of 240 mg/m2
  arm group label: Trilaciclib, Pembrolizumab, Gemcitabine, and Carboplatin
  other name: COSELA
  intervention type: Drug
  intervention name: Pembrolizumab
  description: IV infusion Day 1 every 21 days, at dose of 200 mg
  arm group label: Trilaciclib, Pembrolizumab, Gemcitabine, and Carboplatin
  other name: KEYTRUDA
  intervention type: Drug
  intervention name: Gemcitabine
  description: IV infusion Day 1 and Day 8 every 21 days, at dose 1000 mg/m2
  arm group label: Trilaciclib, Pembrolizumab, Gemcitabine, and Carboplatin
  other name: Gemzar
  intervention type: Drug
  intervention name: Carboplatin
  description: IV infusion Day 1 and Day 8 every 21 days, at dose area under curve (AUC) 2 (maximum of 300 mg)
  arm group label: Trilaciclib, Pembrolizumab, Gemcitabine, and Carboplatin
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Antoinette Tan, MD
  role: Principal Investigator
  affiliation: Wake Forest University Health Sciences
  last name: Leah Wilson
  phone: (980) 442-2333
  email: leah.j.wilson@atriumhealth.org
  facility: 
  contact: 
  investigator: 
  country: United States
  citation: Tan AR, Wright GS, Thummala AR, Danso MA, Popovic L, Pluard TJ, Han HS, Vojnovic Z, Vasev N, Ma L, Richards DA, Wilks ST, Milenkovic D, Yang Z, Antal JM, Morris SR, O'Shaughnessy J. Trilaciclib plus chemotherapy versus chemotherapy alone in patients with metastatic triple-negative breast cancer: a multicentre, randomised, open-label, phase 2 trial. Lancet Oncol. 2019 Nov;20(11):1587-1601. doi: 10.1016/S1470-2045(19)30616-3. Epub 2019 Sep 28.
  PMID: 31575503
  citation: Tan AR, Wright GS, Thummala AR, Danso MA, Popovic L, Pluard TJ, Han HS, Vojnovic Z, Vasev N, Ma L, Richards DA, Wilks ST, Milenkovic D, Xiao J, Sorrentino J, Horton J, O'Shaughnessy J. Trilaciclib Prior to Chemotherapy in Patients with Metastatic Triple-Negative Breast Cancer: Final Efficacy and Subgroup Analysis from a Randomized Phase II Study. Clin Cancer Res. 2022 Feb 15;28(4):629-636. doi: 10.1158/1078-0432.CCR-21-2272.
  PMID: 34887261
  citation: Tan AR, O'Shaughnessy J, Cao S, Ahn S, Yi JS. Investigating potential immune mechanisms of trilaciclib administered prior to chemotherapy in patients with metastatic triple-negative breast cancer. Breast Cancer Res Treat. 2023 Sep;201(2):307-316. doi: 10.1007/s10549-023-07009-8. Epub 2023 Jul 7.
  PMID: 37418031
  responsible party type: Sponsor
  mesh term: Breast Neoplasms
  mesh term: Triple Negative Breast Neoplasms
  mesh term: Carboplatin
  mesh term: Gemcitabine
  mesh term: Pembrolizumab
  sharing ipd: No