<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/NCT01676753</url>
  </required_header>
  <id_info>
    <org_study_id>16758</org_study_id>
    <secondary_id>NCI-2018-01053</secondary_id>
    <nct_id>NCT01676753</nct_id>
  </id_info>
  <brief_title>Phase 1b Trial of Dinaciclib With Pembrolizumab for Advanced Breast Cancer</brief_title>
  <official_title>A Phase 1b Trial of the Cyclin-dependent Kinase Inhibitor Dinaciclib in Combination With Pembrolizumab in Patients With Advanced Breast Cancer and Assessment of MYC Oncogene Overexpression</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jo Chien</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Merck Sharp &amp; Dohme LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, San Francisco</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this trial is to determine the safety and tolerability (maximum tolerated dose&#xD;
      (MTD)) of weekly dinaciclib in combination with pembrolizumab in patients with advanced&#xD;
      breast cancer. Once this is defined, dose expansion will be performed at this MTD in patients&#xD;
      with metastatic or locally advanced and unresectable triple negative breast cancer, to&#xD;
      evaluate the efficacy of combined dinaciclib and pembrolizumab.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVE:&#xD;
&#xD;
      I. Define the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of dinaciclib&#xD;
&#xD;
      SECONDARY OBJECTIVE:&#xD;
&#xD;
      I. Evaluation of the preliminary efficacy of this combination using RECIST 1.1 and irRECIST.&#xD;
&#xD;
      EXPLORATORY OBJECTIVE:&#xD;
&#xD;
      I. Characterizing and correlating PDL-1 and MYC overexpression with clinical response.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      This is an open-label phase Ib trial of weekly dinaciclib in combination pembrolizumab in&#xD;
      participants with advanced triple negative breast cancer. Participants will undergo a single&#xD;
      needle biopsy of a site of active disease prior to initiating treatment of Pembrolizumab and&#xD;
      dinaciclib in 21 day cycles. The dose of dinaciclib will be escalated following a toxicity&#xD;
      probability interval (TPI) design where dose-limiting toxicities (DLT) observed during the&#xD;
      first cycle will be used to determine whether additional participants should be enrolled at&#xD;
      the same, higher, or lower dose level. Treatment will continue until disease progression,&#xD;
      intolerable toxicity, or participant withdraws consent. In the event of a complete response&#xD;
      (CR), participants may elect to hold dinaciclib treatment and continue with pembrolizumab&#xD;
      alone. At the time of radiographic disease progression, dinaciclib can be resumed at the same&#xD;
      dose as at the time of discontinuation. Participants will be followed for 30 days after the&#xD;
      last dose of treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 28, 2016</start_date>
  <completion_date type="Actual">February 28, 2022</completion_date>
  <primary_completion_date type="Actual">June 30, 2020</primary_completion_date>
  <phase>Phase 1</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>Maximum tolerated dose (MTD)</measure>
    <time_frame>Up to 1 cycle (1 cycle is equal to 21 days)</time_frame>
    <description>The MTD is determined by the number of dose-limiting toxicities reported by participants in the first cycle of treatment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of participants with reported dose-limiting toxicities (DLTs)</measure>
    <time_frame>Up to 1 cycle (1 cycle is equal to 21 days)</time_frame>
    <description>Dose-limiting hematologic and non-hematologic toxicities classified using the CTCAE, will be based on events occurring during the first cycle of study drug administration. To be considered a dose-limiting toxicity, an adverse experience must be related to one or both of the study drugs, and must not be related to disease progression or intercurrent illnesses. Participants must receive Day 1 and Day 8 treatments of dinaciclib during the first cycle in order to be evaluable for DLTs (unless missed doses are due to toxicity).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Response Rate</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>Overall tumor response and time to progression will be assessed using RECIST (Response Evaluation Criteria in Solid Tumors) 1.1 criteria and immune-related RECIST (irRECIST) which takes into account the clinical condition/stability of subjects in addition to tumor imaging. The rate of participants with a confirmed response classified as Complete Response (CR, iCR) (the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to &lt;10 mm) or a Partial Response (PR, iPR) (defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters or unconfirmed progressive disease (iUPD) will be reported.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Advanced or Metastatic Breast Cancer</condition>
  <condition>Triple Negative Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Treatment (Dinaciclib, Pembrolizumab)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Pembrolizumab will be administered on Day 1, every 3 weeks at a fixed dose of 200 mg IV. Dinaciclib will be administered D1 and D8 of a 21 day cycle by 2-hour intravenous infusion starting at Dose Level (DL) 1 of 12 mg/m^2. Further dose escalation cohorts are defined as follows: DL 2: 18 mg/m^2, DL 3: 25 mg/m^2, DL 4: 33 mg/m^2, and DL 5: 50 mg/m^2</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dinaciclib</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Treatment (Dinaciclib, Pembrolizumab)</arm_group_label>
    <other_name>SCH727965</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pembrolizumab</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Treatment (Dinaciclib, Pembrolizumab)</arm_group_label>
    <other_name>Keytruda</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        INCLUSION CRITERIA:&#xD;
&#xD;
          1. Histologically or cytologically documented, incurable, unresectable locally advanced,&#xD;
             or metastatic breast cancer&#xD;
&#xD;
          2. Histologically documented metastatic or locally advanced unresectable breast cancer&#xD;
             that is ER and progesterone receptor (PR) &lt;10% expression and does not over-express&#xD;
             Hormone Estrogen Receptor-Positive (HER2) protein (Immunohistochemistry (IHC) 0, 1+,&#xD;
             or 2+ and Fluorescent in situ hybridization (FISH) &lt;2.0)&#xD;
&#xD;
          3. Patient must consent to a biopsy of a site of disease unless the only site of disease&#xD;
             is lung/pleura, bone, or deemed unsafe by the principal investigator&#xD;
&#xD;
          4. Patient is male or female and ≥18 years of age on the day of signing informed consent.&#xD;
&#xD;
          5. Patient must have performance status of 0-1 on the Eastern Cooperative Oncology Group&#xD;
             (ECOG) Performance Scale and life expectancy &gt; 3 months&#xD;
&#xD;
          6. Patient must have evaluable disease&#xD;
&#xD;
          7. Patient must have adequate organ function as indicated by the following laboratory&#xD;
             values:&#xD;
&#xD;
             Hematological&#xD;
&#xD;
               -  Absolute neutrophil count (ANC) ≥ 1,500 /μL&#xD;
&#xD;
               -  Platelets ≥ 100,000 /μL&#xD;
&#xD;
               -  Hemoglobin ≥ 9 g/dL&#xD;
&#xD;
             Renal&#xD;
&#xD;
               -  Serum creatinine or calculated creatinine clearance ≤ 1.5 x upper limit of normal&#xD;
                  (ULN) OR&#xD;
&#xD;
               -  ≥ 60 mL/min for patients with creatinine levels &gt; 1.5 x institutional ULN&#xD;
&#xD;
             Hepatic&#xD;
&#xD;
               -  Serum total bilirubin ≤ 1.5 x ULN OR direct bilirubin ≤ ULN for patients with&#xD;
                  total bilirubin levels &gt; 1.5 x ULN&#xD;
&#xD;
               -  Aspartate aminotransferase (AST) / serum glutamic-oxaloacetic transaminase (SGOT)&#xD;
                  and alanine aminotransferase (ALT) / serum glutamic-pyruvic transaminase (SGPT) ≤&#xD;
                  2.5 x ULN, ≤ 5 x ULN if liver metastasis&#xD;
&#xD;
             Coagulation&#xD;
&#xD;
               -  Prothrombin time (PT)/International Normalized Ratio (INR) ≤ 1.2 x ULN&#xD;
&#xD;
               -  Partial thromboplastin time (PTT) ≤ 1.2 x ULN&#xD;
&#xD;
          8. Female patient of childbearing potential must have a negative serum or urine pregnancy&#xD;
             test β-human chorionic gonadotropin (hCG) within 72 hours prior to first doses of&#xD;
             study medication . If the urine test is positive or cannot be confirmed as negative, a&#xD;
             serum pregnancy test will be required.&#xD;
&#xD;
          9. Female subjects of childbearing potential must be willing to use an adequate method of&#xD;
             contraception for the course of the study through 120 days after the last dose of&#xD;
             study medication.&#xD;
&#xD;
             Note: Abstinence is acceptable if this is the usual lifestyle and preferred&#xD;
             contraception for the subject.&#xD;
&#xD;
         10. Male subjects of childbearing potential must agree to use an adequate method of&#xD;
             contraception starting with the first dose of study therapy through 120 days after the&#xD;
             last dose of study therapy. Note: Abstinence is acceptable if this is the usual&#xD;
             lifestyle and preferred contraception for the subject.&#xD;
&#xD;
         11. Patient has voluntarily agreed to participate by giving written informed consent&#xD;
&#xD;
         12. Concomitant use of bisphosphonates or nuclear factor-κB (RANK) ligand inhibitors is&#xD;
             allowed.&#xD;
&#xD;
        EXCLUSION CRITERIA:&#xD;
&#xD;
          1. Patient who has had radiotherapy within 1 week (or unresolved radiation-related&#xD;
             toxicities), chemotherapy within 2 weeks or 5 half-lives, whichever is longer (6 weeks&#xD;
             for nitrosoureas, mitomycin C or bevacizumab), anti-cancer monoclonal antibody for&#xD;
             direct anti-neoplastic treatment within 3 weeks, or who has not recovered from&#xD;
             toxicity due to previous agents administered. If the patient has residual toxicity&#xD;
             from prior treatment, toxicity must be ≤ Grade 1 (except for neuropathy and alopecia).&#xD;
&#xD;
          2. &gt; 2 lines of prior chemotherapy in the metastatic setting&#xD;
&#xD;
          3. Serum lactate dehydrogenase (LDH) &gt; 1.5x institutional ULN&#xD;
&#xD;
          4. Patients less than 2 weeks post major surgical procedure (all surgical wounds must be&#xD;
             fully healed). For the purpose of this criterion, a major surgical procedure is&#xD;
             defined as one requiring the administration of general anesthesia.&#xD;
&#xD;
          5. Patient is currently participating in a study with an investigational compound or&#xD;
             device.&#xD;
&#xD;
          6. Patient has known active central nervous system (CNS) metastases and/or carcinomatous&#xD;
             meningitis. However, patients with CNS metastases who have completed a course of&#xD;
             therapy would be eligible for the study provided they are clinically stable for at&#xD;
             least 4 weeks prior to entry as defined as: (1) no evidence of new or enlarging CNS&#xD;
             metastasis on brain imaging within 4 weeks of enrollment (2) off steroids for 2 weeks.&#xD;
             Patients with clinically insignificant brain metastases that do not require treatment&#xD;
             are eligible.&#xD;
&#xD;
          7. Patient has a primary central nervous system tumor&#xD;
&#xD;
          8. Patient has known hypersensitivity to the components of study drug or its analogs.&#xD;
&#xD;
          9. Patient has a history or current evidence of clinically significant heart disease&#xD;
             including:&#xD;
&#xD;
               -  Clinically significant congestive heart failure, unstable angina pectoris,&#xD;
&#xD;
               -  Clinically significant cardiac arrhythmia,&#xD;
&#xD;
               -  Myocardial infarction during the last 6 months, and/or a current ECG tracing that&#xD;
                  is abnormal in the opinion of the treating Investigator,&#xD;
&#xD;
               -  QTc prolongation &gt;480 msec (Bazett's Formula),&#xD;
&#xD;
               -  Congenitally long QT syndrome, and/or current anti-arrhythmic therapy&#xD;
&#xD;
         10. Patient with evidence of clinically significant bradycardia (HR &lt;50), or a history of&#xD;
             clinically significant bradyarrhythmias such as sick sinus syndrome, 2nd degree&#xD;
             atrioventricular (AV) block (Mobitz Type 2), Patient with uncontrolled hypertension&#xD;
             (≥140/90 mmHg). Patients who are controlled on antihypertensive medication will be&#xD;
             allowed to enter the study.&#xD;
&#xD;
         11. Patient has a history or current evidence of any condition, therapy, or lab&#xD;
             abnormality that might confound the results of the study, interfere with the patient's&#xD;
             participation for the full duration of the study, or is not in the best interest of&#xD;
             the patient to participate, in the opinion of the treating investigator.&#xD;
&#xD;
         12. Patient has known psychiatric or substance abuse disorders that would interfere with&#xD;
             cooperation with the requirements of the trial&#xD;
&#xD;
         13. Patient is, at the time of signing informed consent, a regular user of any illicit&#xD;
             drugs or had a recent history (within the last year) of drug or alcohol abuse.&#xD;
&#xD;
         14. Patient is pregnant or breastfeeding, or expecting to conceive or father children&#xD;
             within the projected duration of the study&#xD;
&#xD;
         15. Patient is known to be Human Immunodeficiency Virus (HIV)-positive&#xD;
&#xD;
         16. Patient has known history of active Hepatitis A, B, or C&#xD;
&#xD;
         17. Patients who have known allergic reactions to IV contrast dye despite standard&#xD;
             prophylaxis&#xD;
&#xD;
         18. Patients who require medications that are strong CYP3A4 inhibitors or inducers.&#xD;
&#xD;
         19. Patients who have discontinued any of these medications must have a wash-out period of&#xD;
             at least 5 days or at least 5 half-lives of the drug (whichever is longer) prior to&#xD;
             the first dose of dinaciclib (Refer to Appendix 2 Drugs that interact strongly with&#xD;
             CYP3A4).&#xD;
&#xD;
         20. Patients requiring warfarin therapy are excluded, low molecular weight heparin is&#xD;
             permitted.&#xD;
&#xD;
         21. Patient has a diagnosis of immunodeficiency or is receiving ongoing immunosuppressive&#xD;
             therapy, including systemic or enteric corticosteroids except for non-systemically&#xD;
             absorbed treatments (such as inhaled or topical steroid therapy for asthma, chronic&#xD;
             obstructive pulmonary disease, allergic rhinitis). Patient must be off systemic&#xD;
             steroid or any other form of immunosuppressive therapy within 7 days prior to first&#xD;
             dose of trial treatment.&#xD;
&#xD;
         22. Patient is diagnosed with active autoimmune disease that has required systemic&#xD;
             treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids&#xD;
             or immunosuppressive drugs). Note: replacement therapy (e.g., thyroxine, insulin, or&#xD;
             physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency)&#xD;
             is not considered a form of systemic treatment.&#xD;
&#xD;
         23. Patient has history of interstitial lung disease or known history of, or any evidence&#xD;
             of active, noninfectious pneumonitis.&#xD;
&#xD;
         24. Patient has history of severe allergic, anaphylactic, or other hypersensitivity&#xD;
             reactions to chimeric or humanized antibodies or prior allogeneic bone marrow&#xD;
             transplantation or prior solid organ transplantation.&#xD;
&#xD;
         25. Has received a live vaccine within 30 days of planned start of study therapy. Note:&#xD;
             Seasonal influenza vaccines for injection are generally inactivated flu vaccines and&#xD;
             are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live&#xD;
             attenuated vaccines, and are not allowed.&#xD;
&#xD;
        Inclusion of women and minorities:&#xD;
&#xD;
        Both men and women and members of all races and ethnic groups are eligible for this trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>A. Jo Chien, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Francisco</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of California, San Francisco</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94143</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>August 24, 2012</study_first_submitted>
  <study_first_submitted_qc>August 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 31, 2012</study_first_posted>
  <last_update_submitted>September 16, 2022</last_update_submitted>
  <last_update_submitted_qc>September 16, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 21, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of California, San Francisco</investigator_affiliation>
    <investigator_full_name>Jo Chien</investigator_full_name>
    <investigator_title>UCSF Assistant Clinical Professor</investigator_title>
  </responsible_party>
  <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>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>


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/NCT01676753
org study id: 16758
secondary id: NCI-2018-01053
nct id: NCT01676753
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this trial is to determine the safety and tolerability (maximum tolerated dose
      (MTD)) of weekly dinaciclib in combination with pembrolizumab in patients with advanced
      breast cancer. Once this is defined, dose expansion will be performed at this MTD in patients
      with metastatic or locally advanced and unresectable triple negative breast cancer, to
      evaluate the efficacy of combined dinaciclib and pembrolizumab.
PRIMARY OBJECTIVE:

      I. Define the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of dinaciclib

      SECONDARY OBJECTIVE:

      I. Evaluation of the preliminary efficacy of this combination using RECIST 1.1 and irRECIST.

      EXPLORATORY OBJECTIVE:

      I. Characterizing and correlating PDL-1 and MYC overexpression with clinical response.

      OUTLINE:

      This is an open-label phase Ib trial of weekly dinaciclib in combination pembrolizumab in
      participants with advanced triple negative breast cancer. Participants will undergo a single
      needle biopsy of a site of active disease prior to initiating treatment of Pembrolizumab and
      dinaciclib in 21 day cycles. The dose of dinaciclib will be escalated following a toxicity
      probability interval (TPI) design where dose-limiting toxicities (DLT) observed during the
      first cycle will be used to determine whether additional participants should be enrolled at
      the same, higher, or lower dose level. Treatment will continue until disease progression,
      intolerable toxicity, or participant withdraws consent. In the event of a complete response
      (CR), participants may elect to hold dinaciclib treatment and continue with pembrolizumab
      alone. At the time of radiographic disease progression, dinaciclib can be resumed at the same
      dose as at the time of discontinuation. Participants will be followed for 30 days after the
      last dose of treatment.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Maximum tolerated dose (MTD)
time frame: Up to 1 cycle (1 cycle is equal to 21 days)
description: The MTD is determined by the number of dose-limiting toxicities reported by participants in the first cycle of treatment.
measure: Proportion of participants with reported dose-limiting toxicities (DLTs)
time frame: Up to 1 cycle (1 cycle is equal to 21 days)
description: Dose-limiting hematologic and non-hematologic toxicities classified using the CTCAE, will be based on events occurring during the first cycle of study drug administration. To be considered a dose-limiting toxicity, an adverse experience must be related to one or both of the study drugs, and must not be related to disease progression or intercurrent illnesses. Participants must receive Day 1 and Day 8 treatments of dinaciclib during the first cycle in order to be evaluable for DLTs (unless missed doses are due to toxicity).
measure: Overall Response Rate
time frame: Up to 3 years
description: Overall tumor response and time to progression will be assessed using RECIST (Response Evaluation Criteria in Solid Tumors) 1.1 criteria and immune-related RECIST (irRECIST) which takes into account the clinical condition/stability of subjects in addition to tumor imaging. The rate of participants with a confirmed response classified as Complete Response (CR, iCR) (the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm) or a Partial Response (PR, iPR) (defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters or unconfirmed progressive disease (iUPD) will be reported.
arm group label: Treatment (Dinaciclib, Pembrolizumab)
arm group type: Experimental
description: Pembrolizumab will be administered on Day 1, every 3 weeks at a fixed dose of 200 mg IV. Dinaciclib will be administered D1 and D8 of a 21 day cycle by 2-hour intravenous infusion starting at Dose Level (DL) 1 of 12 mg/m^2. Further dose escalation cohorts are defined as follows: DL 2: 18 mg/m^2, DL 3: 25 mg/m^2, DL 4: 33 mg/m^2, and DL 5: 50 mg/m^2
intervention type: Drug
intervention name: Dinaciclib
description: Given IV
arm group label: Treatment (Dinaciclib, Pembrolizumab)
other name: SCH727965
intervention type: Drug
intervention name: Pembrolizumab
description: Given IV
arm group label: Treatment (Dinaciclib, Pembrolizumab)
other name: Keytruda
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: A. Jo Chien, MD
role: Principal Investigator
affiliation: University of California, San Francisco
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: University of California, San Francisco
investigator full name: Jo Chien
investigator title: UCSF Assistant Clinical Professor
mesh term: Breast Neoplasms
mesh term: Triple Negative Breast Neoplasms
mesh term: Pembrolizumab
sharing ipd: No