<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/NCT03805399</url>
  </required_header>
  <id_info>
    <org_study_id>1807188-16</org_study_id>
    <nct_id>NCT03805399</nct_id>
  </id_info>
  <brief_title>FUSCC Refractory TNBC Umbrella (FUTURE)</brief_title>
  <acronym>FUTURE</acronym>
  <official_title>Precision Treatment of Refractory Triple Negative Breast Cancer Based on Molecular Subtyping --FUSCC-TNBC- Umbrella Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fudan University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fudan University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a Phase Ib/II, open-label, multi-center umbrella study evaluating the efficacy and&#xD;
      safety of multiple targeted treatment in patients with refractory metastatic TNBC.The&#xD;
      specific grouping of patients' depends on FUSCC 500+ gene panel testing and IHC subtype&#xD;
      staining.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a Phase Ib/II, open-label, multi-center,umbrella study evaluating the efficacy and&#xD;
      safety of multiple targeted treatment in patients with metastatic TNBC who had disease&#xD;
      progression during or following standard treatment with&#xD;
      chemotherapy(anthracyclines,taxanes,platinums, vinorelbine,capecitabine,and gemcitabine&#xD;
      included).300-400 patients will be screened and eligible participants will enter different&#xD;
      treatment arms according to their molecular subtype (IHC staining) and FUSCC 500+ gene panel&#xD;
      testing results. These tests would be done on their rebiopsy tumor specimen. Specifically, as&#xD;
      to TNBC molecular subtyping,FUSCC data identified the genomic aberrations that drive each&#xD;
      TNBC subtype by applying an integrative analysis combining somatic mutation, copy number&#xD;
      aberrations (CNAs) and gene expression profiles, which classified TNBC patients into four&#xD;
      subtypes, namely luminal androgen receptor (LAR), immunomodulatory (IM), basal-like immune&#xD;
      suppressed (BLIS), and mesenchymal-like (MES). Then, FUSCC conducted a IHC subtyping model to&#xD;
      replace complex genomic sequencing, which have been validated in FUSCC cohort.FUSCC 500+ gene&#xD;
      panel was developed combining public database(TCGA, METABRIC, 560WES, MSKCC-IMPACT ect.) and&#xD;
      FUSCC private TNBC database.New treatment arms may be added and/or existing treatment arms&#xD;
      may be closed during the course of the study on the basis of ongoing clinical efficacy and&#xD;
      safety as well as the current treatments available.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 18, 2018</start_date>
  <completion_date type="Anticipated">December 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2022</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>The refractory mTNBC participants will be classified into four subtypes based on immunohistochemistry tests namely luminal androgen receptor (LAR), immunomodulatory (IM), basal-like immune suppressed (BLIS), and mesenchymal (MES).Then according to gene sequencing outcomes, different subtypes would receive different targeted therapy (combined with chemotherapy in three treatment arms).</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Objective Response Rate (ORR)</measure>
    <time_frame>Randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the end of study (approximately 3 years)</time_frame>
    <description>The proportion of participants whose best outcome is complete remission or partial remission (according to RECIST1.1)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Disease Control Rate(DOR)</measure>
    <time_frame>Baseline through end of study (approximately 3 years)</time_frame>
    <description>Complete remission or partial remission or stable disease (according to RECIST1.1)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression Free Survival(PFS)</measure>
    <time_frame>Randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the end of study (approximately 3 years)</time_frame>
    <description>time to progressive disease (according to RECIST1.1)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>Randomization to death from any cause, through the end of study (approximately 3 years)</time_frame>
    <description>time to death due to any cause</description>
  </secondary_outcome>
  <number_of_arms>7</number_of_arms>
  <enrollment type="Anticipated">140</enrollment>
  <condition>Triple-negative Breast Cancer</condition>
  <arm_group>
    <arm_group_label>pyrotinib with capecitabine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>If patients were LAR subtype with HER2 gene activated mutation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AR inhibitor with CDK4/6 inhibitor</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>If patients were LAR subtype without HER2 gene activated mutation, but had PIK3CA mutation, enter into arm B1; If patients were LAR subtype without HER2 gene activated mutation or PIK3CA mutation, enter into arm B2;If B2 was closed, enter into B4;</description>
  </arm_group>
  <arm_group>
    <arm_group_label>anti PD-1 with nab-paclitaxel</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>If patients were IM subtype(CD8 positive T cell more than 20%)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PARP inhibitor included therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>If patients were BLIS subtype and had a BRCA gene pathogenic mutation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BLIS with anti-VEGFR included therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>If patients were BLIS subtype and did not have a BRCA gene pathogenic mutation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MES with anti-VEGFR included therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>If patients were MES subtype and without PI3K/AKT pathway activation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>mTOR inhibitor with nab-paclitaxel</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>If patients were MES subtype and had PI3K/AKT pathway activation</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pyrotinib with Capecitabine</intervention_name>
    <description>If patients were LAR subtype with HER2 gene activated mutation, she would receive pyrotinib(EGFR-TKI) 400mg qd and capecitabine 1000mg/m2 bid (d1-d14)</description>
    <arm_group_label>pyrotinib with capecitabine</arm_group_label>
    <other_name>SHR1258</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AR inhibitor combined with everolimus(B1) or CDK4/6 inhibitor(B2),or EZH2 inhibitor (B4)</intervention_name>
    <description>B1: if patients were LAR subtype without HER2 gene activated mutation, but had PI3KCA mutation, she would receive everolimus 10mg qd combined with AR inhibitor SHR3680 240mg qd continuously ; B2: if patients were LAR subtype without HER2 gene activated mutation or PI3KCA mutation, she would receive AR inhibitor SHR3680 240mg qd combined with CDK4/6 inhibitor SHR6390 150mg qd (three week on one week off); B4: If patients were LAR subtype without HER2 gene activated mutation or PI3KCA mutation, she would receive AR inhibitor SHR3680 240mg qd combined with EZH2 inhibitor SHR2554 300mg bid continuously</description>
    <arm_group_label>AR inhibitor with CDK4/6 inhibitor</arm_group_label>
    <other_name>SHR3680 SHR6390</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>anti PD-1 with nab-paclitaxel</intervention_name>
    <description>If patients were IM subtype, she will receive PD-1 antibody SHR1210 200mg q2w and nab-paclitaxel 100mg qw (three week on one week off).</description>
    <arm_group_label>anti PD-1 with nab-paclitaxel</arm_group_label>
    <other_name>SHR1210</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PARP inhibitor included therapy</intervention_name>
    <description>If patients were BLIS subtype and had a BRCA gene pathogenic mutation, she will receive PARP inhibitor SHR3162 150mg bid and famitinib 20mg qd continuously .</description>
    <arm_group_label>PARP inhibitor included therapy</arm_group_label>
    <other_name>SHR3162</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BLIS with anti-VEGFR included therapy</intervention_name>
    <description>If patients were BLIS subtype and did not have a BRCA gene pathogenic mutation , she will receive:&#xD;
E2: apatinib 250mg qd continuously combined with VP-16 50mg qd (three week on one week off); E3: famitinib 20mg qd continuously combined with VP-16 50mg qd (three week on one week off); E4: BP102 10mg/kg d1,d15 combined with nab-paclitaxel 100mg d1,d8,d,15; q4w</description>
    <arm_group_label>BLIS with anti-VEGFR included therapy</arm_group_label>
    <other_name>YN968D1</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MES with anti-VEGFR included therapy</intervention_name>
    <description>If patients were MES subtype and without PI3K/AKT pathway activation,she will receive famitinib 20mg qd continuously combined with VP-16 50mg qd (three week on one week off).</description>
    <arm_group_label>MES with anti-VEGFR included therapy</arm_group_label>
    <other_name>YN968D1</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>mTOR inhibitor with nab-paclitaxel</intervention_name>
    <description>If patients were MES subtype and had PI3K/AKT pathway activation, she will receive mTOR inhibitor 10mg qd continuously combined with nab-paclitaxel 100mg qw (three week on one week off).</description>
    <arm_group_label>mTOR inhibitor with nab-paclitaxel</arm_group_label>
    <other_name>everolimus</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ECOG Performance Status of 0, 1, or 2&#xD;
&#xD;
          -  Metastatic or locally advanced, histologically documented TNBC (absence of HER2, ER,&#xD;
             and PR expression)&#xD;
&#xD;
          -  Radiologic/objective evidence of recurrence or disease progression after available&#xD;
             standard chemotherapy regimens(anthracyclines,taxanes, platinums,&#xD;
             vinorelbine,capacitabine, and gemcitabine included) for metastatic breast cancer(MBC)&#xD;
&#xD;
          -  Availability of a representative tumor specimen that is suitable for rebiopsy, IHC&#xD;
             staining and gene sequencing&#xD;
&#xD;
          -  Adequate hematologic and end-organ function, laboratory test results, obtained within&#xD;
             14 days prior to initiation of study treatment.&#xD;
&#xD;
          -  For women of childbearing potential: agreement to remain abstinent (refrain from&#xD;
             heterosexual intercourse) or use contraceptive measures as outlined for each specific&#xD;
             treatment arm&#xD;
&#xD;
          -  Measurable disease according to Response Evaluation Criteria in Solid Tumors v1.1&#xD;
             (RECIST v1.1)&#xD;
&#xD;
          -  have the cognitive ability to understand the protocol and be willing to participate&#xD;
             and to be followed up.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Symptomatic, untreated, or actively progressing CNS metastases&#xD;
&#xD;
          -  Active or history of autoimmune disease or immune deficiency&#xD;
&#xD;
          -  Significant cardiovascular disease&#xD;
&#xD;
          -  History of malignancy other than breast cancer within 5 years prior to screening, with&#xD;
             the exception of those with a negligible risk of metastasis or death&#xD;
&#xD;
          -  Treatment with chemotherapy, radiotherapy,immunotherapy or surgery (outpatient clinic&#xD;
             surgery excluded)within3 weeks prior to initiation of study treatment.&#xD;
&#xD;
          -  Pregnancy or breastfeeding, or intention of becoming pregnant during the study&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zhimin U Shao, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fudan University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Zhimin U Shao, Professor</last_name>
    <phone>86-021-64175590</phone>
    <phone_ext>88807</phone_ext>
    <email>zhimingshao@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Zhonghua U Wang,Professor</last_name>
    <phone>86-021-64175590</phone>
    <phone_ext>88603</phone_ext>
    <email>zhonghuawang95@hotmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Fudan University Shanghai Cancer Center</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zhimin Shao M.D.</last_name>
      <phone>86-021-64175590</phone>
      <phone_ext>88807</phone_ext>
      <email>zhimingshao@yahoo.com</email>
    </contact>
    <contact_backup>
      <last_name>Yin Liu,Doctor</last_name>
      <phone>86-021-64175590</phone>
      <phone_ext>88603</phone_ext>
      <email>liuyinfudan@163.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>January 8, 2019</study_first_submitted>
  <study_first_submitted_qc>January 13, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <last_update_submitted>August 8, 2022</last_update_submitted>
  <last_update_submitted_qc>August 8, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 10, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fudan University</investigator_affiliation>
    <investigator_full_name>Zhimin Shao</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>TNBC</keyword>
  <keyword>Molecular Subtype</keyword>
  <keyword>Precision Treatment</keyword>
  <keyword>Umbrella</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>Sirolimus</mesh_term>
    <mesh_term>Paclitaxel</mesh_term>
    <mesh_term>Albumin-Bound Paclitaxel</mesh_term>
    <mesh_term>Capecitabine</mesh_term>
    <mesh_term>Everolimus</mesh_term>
    <mesh_term>Apatinib</mesh_term>
    <mesh_term>Temsirolimus</mesh_term>
    <mesh_term>MTOR Inhibitors</mesh_term>
    <mesh_term>Poly(ADP-ribose) Polymerase Inhibitors</mesh_term>
  </intervention_browse>
  <!-- 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/NCT03805399
org study id: 1807188-16
nct id: NCT03805399
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a Phase Ib/II, open-label, multi-center umbrella study evaluating the efficacy and
      safety of multiple targeted treatment in patients with refractory metastatic TNBC.The
      specific grouping of patients' depends on FUSCC 500+ gene panel testing and IHC subtype
      staining.
This is a Phase Ib/II, open-label, multi-center,umbrella study evaluating the efficacy and
      safety of multiple targeted treatment in patients with metastatic TNBC who had disease
      progression during or following standard treatment with
      chemotherapy(anthracyclines,taxanes,platinums, vinorelbine,capecitabine,and gemcitabine
      included).300-400 patients will be screened and eligible participants will enter different
      treatment arms according to their molecular subtype (IHC staining) and FUSCC 500+ gene panel
      testing results. These tests would be done on their rebiopsy tumor specimen. Specifically, as
      to TNBC molecular subtyping,FUSCC data identified the genomic aberrations that drive each
      TNBC subtype by applying an integrative analysis combining somatic mutation, copy number
      aberrations (CNAs) and gene expression profiles, which classified TNBC patients into four
      subtypes, namely luminal androgen receptor (LAR), immunomodulatory (IM), basal-like immune
      suppressed (BLIS), and mesenchymal-like (MES). Then, FUSCC conducted a IHC subtyping model to
      replace complex genomic sequencing, which have been validated in FUSCC cohort.FUSCC 500+ gene
      panel was developed combining public database(TCGA, METABRIC, 560WES, MSKCC-IMPACT ect.) and
      FUSCC private TNBC database.New treatment arms may be added and/or existing treatment arms
      may be closed during the course of the study on the basis of ongoing clinical efficacy and
      safety as well as the current treatments available.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: The refractory mTNBC participants will be classified into four subtypes based on immunohistochemistry tests namely luminal androgen receptor (LAR), immunomodulatory (IM), basal-like immune suppressed (BLIS), and mesenchymal (MES).Then according to gene sequencing outcomes, different subtypes would receive different targeted therapy (combined with chemotherapy in three treatment arms).
primary purpose: Treatment
masking: None (Open Label)
measure: Objective Response Rate (ORR)
time frame: Randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the end of study (approximately 3 years)
description: The proportion of participants whose best outcome is complete remission or partial remission (according to RECIST1.1)
measure: Disease Control Rate(DOR)
time frame: Baseline through end of study (approximately 3 years)
description: Complete remission or partial remission or stable disease (according to RECIST1.1)
measure: Progression Free Survival(PFS)
time frame: Randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the end of study (approximately 3 years)
description: time to progressive disease (according to RECIST1.1)
measure: Overall Survival (OS)
time frame: Randomization to death from any cause, through the end of study (approximately 3 years)
description: time to death due to any cause
arm group label: pyrotinib with capecitabine
arm group type: Experimental
description: If patients were LAR subtype with HER2 gene activated mutation
arm group label: AR inhibitor with CDK4/6 inhibitor
arm group type: Experimental
description: If patients were LAR subtype without HER2 gene activated mutation, but had PIK3CA mutation, enter into arm B1; If patients were LAR subtype without HER2 gene activated mutation or PIK3CA mutation, enter into arm B2;If B2 was closed, enter into B4;
arm group label: anti PD-1 with nab-paclitaxel
arm group type: Experimental
description: If patients were IM subtype(CD8 positive T cell more than 20%)
arm group label: PARP inhibitor included therapy
arm group type: Experimental
description: If patients were BLIS subtype and had a BRCA gene pathogenic mutation
arm group label: BLIS with anti-VEGFR included therapy
arm group type: Experimental
description: If patients were BLIS subtype and did not have a BRCA gene pathogenic mutation
arm group label: MES with anti-VEGFR included therapy
arm group type: Experimental
description: If patients were MES subtype and without PI3K/AKT pathway activation
arm group label: mTOR inhibitor with nab-paclitaxel
arm group type: Experimental
description: If patients were MES subtype and had PI3K/AKT pathway activation
intervention type: Drug
intervention name: Pyrotinib with Capecitabine
description: If patients were LAR subtype with HER2 gene activated mutation, she would receive pyrotinib(EGFR-TKI) 400mg qd and capecitabine 1000mg/m2 bid (d1-d14)
arm group label: pyrotinib with capecitabine
other name: SHR1258
intervention type: Drug
intervention name: AR inhibitor combined with everolimus(B1) or CDK4/6 inhibitor(B2),or EZH2 inhibitor (B4)
description: B1: if patients were LAR subtype without HER2 gene activated mutation, but had PI3KCA mutation, she would receive everolimus 10mg qd combined with AR inhibitor SHR3680 240mg qd continuously ; B2: if patients were LAR subtype without HER2 gene activated mutation or PI3KCA mutation, she would receive AR inhibitor SHR3680 240mg qd combined with CDK4/6 inhibitor SHR6390 150mg qd (three week on one week off); B4: If patients were LAR subtype without HER2 gene activated mutation or PI3KCA mutation, she would receive AR inhibitor SHR3680 240mg qd combined with EZH2 inhibitor SHR2554 300mg bid continuously
arm group label: AR inhibitor with CDK4/6 inhibitor
other name: SHR3680 SHR6390
intervention type: Drug
intervention name: anti PD-1 with nab-paclitaxel
description: If patients were IM subtype, she will receive PD-1 antibody SHR1210 200mg q2w and nab-paclitaxel 100mg qw (three week on one week off).
arm group label: anti PD-1 with nab-paclitaxel
other name: SHR1210
intervention type: Drug
intervention name: PARP inhibitor included therapy
description: If patients were BLIS subtype and had a BRCA gene pathogenic mutation, she will receive PARP inhibitor SHR3162 150mg bid and famitinib 20mg qd continuously .
arm group label: PARP inhibitor included therapy
other name: SHR3162
intervention type: Drug
intervention name: BLIS with anti-VEGFR included therapy
description: If patients were BLIS subtype and did not have a BRCA gene pathogenic mutation , she will receive:
E2: apatinib 250mg qd continuously combined with VP-16 50mg qd (three week on one week off); E3: famitinib 20mg qd continuously combined with VP-16 50mg qd (three week on one week off); E4: BP102 10mg/kg d1,d15 combined with nab-paclitaxel 100mg d1,d8,d,15; q4w
arm group label: BLIS with anti-VEGFR included therapy
other name: YN968D1
intervention type: Drug
intervention name: MES with anti-VEGFR included therapy
description: If patients were MES subtype and without PI3K/AKT pathway activation,she will receive famitinib 20mg qd continuously combined with VP-16 50mg qd (three week on one week off).
arm group label: MES with anti-VEGFR included therapy
other name: YN968D1
intervention type: Drug
intervention name: mTOR inhibitor with nab-paclitaxel
description: If patients were MES subtype and had PI3K/AKT pathway activation, she will receive mTOR inhibitor 10mg qd continuously combined with nab-paclitaxel 100mg qw (three week on one week off).
arm group label: mTOR inhibitor with nab-paclitaxel
other name: everolimus
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Zhimin U Shao, Professor
role: Principal Investigator
affiliation: Fudan University
last name: Zhimin U Shao, Professor
phone: 86-021-64175590
phone ext: 88807
email: zhimingshao@yahoo.com
last name: Zhonghua U Wang,Professor
phone: 86-021-64175590
phone ext: 88603
email: zhonghuawang95@hotmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Fudan University
investigator full name: Zhimin Shao
investigator title: Professor
mesh term: Breast Neoplasms
mesh term: Triple Negative Breast Neoplasms
mesh term: Sirolimus
mesh term: Paclitaxel
mesh term: Albumin-Bound Paclitaxel
mesh term: Capecitabine
mesh term: Everolimus
mesh term: Apatinib
mesh term: Temsirolimus
mesh term: MTOR Inhibitors
mesh term: Poly(ADP-ribose) Polymerase Inhibitors