<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/NCT02187991</url>
  </required_header>
  <id_info>
    <org_study_id>13-033</org_study_id>
    <nct_id>NCT02187991</nct_id>
  </id_info>
  <brief_title>Study to Compare Alisertib With Paclitaxel vs. Paclitaxel Alone in Metastatic or Locally Recurrent Breast Cancer</brief_title>
  <official_title>A Phase II, Multicenter, Randomized, Parallel Group Study to Compare Alisertib in Combination With Paclitaxel vs. Paclitaxel Alone in Patients With Metastatic or Locally Recurrent Breast Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>US Oncology Research</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Millennium Pharmaceuticals, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>US Oncology Research</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this clinical research study is to learn if the study drug, alisertib, in&#xD;
      combination with chemotherapy (paclitaxel), can shrink or slow tumor growth in women with&#xD;
      hormone receptor (HR)-positive, HER2-negative or HR-negative, HER2-negative (triple negative)&#xD;
      locally recurrent or metastatic breast cancer. The safety of alisertib in combination with&#xD;
      paclitaxel will also be studied. The physical state of the patient, symptoms, changes in the&#xD;
      size of the tumor, and laboratory findings obtained while on-study will help the research&#xD;
      team decide if alisertib plus paclitaxel is safe and effective in patients with this type of&#xD;
      breast cancer.&#xD;
&#xD;
      Alisertib belongs to a group of drugs called Aurora kinase inhibitors. Alisertib blocks the&#xD;
      activity of Aurora A kinase, a protein that is involved in tumor cell multiplication and&#xD;
      survival. Aurora A kinase is expressed at higher than normal levels in many types of cancer,&#xD;
      including breast cancer, and preclinical studies suggest that blocking the activity of this&#xD;
      protein can lead to the death of cancer cells.&#xD;
&#xD;
      Paclitaxel is a chemotherapy drug commonly used to treat many different kinds of cancer,&#xD;
      including metastatic breast cancer. The reason to combine alisertib and paclitaxel is that in&#xD;
      cancer therapy, combinations of drugs are often more effective as a treatment than either of&#xD;
      the same drugs used alone.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The rationale behind assessing the effectiveness of the addition of alisertib to weekly&#xD;
      paclitaxel therapy in patients with Triple Negative Breast Cancer and highly proliferative&#xD;
      ER+ and HER2- breast cancer is based on the unmet clinical need for effective strategies to&#xD;
      prevent or delay resistance to taxane therapy in the metastatic setting. Synergistic or&#xD;
      additive effects have been observed in breast cancer xenograft models which involved&#xD;
      alisertib added to either paclitaxel or docetaxel. Alisertib inhibited the Pgp-mediated&#xD;
      efflux of paclitaxel in a cell culture model. In addition, Aurora Kinase A is frequently&#xD;
      overexpressed in Triple Negative Breast Cancer (TNBC), and expression levels have been shown&#xD;
      to be prognostic in both of these breast cancer subtypes. The combination of alisertib with&#xD;
      paclitaxel has also been investigated in a Phase 1 study in patients with locally advanced or&#xD;
      metastatic ovarian and breast cancers, with preliminary evidence of activity in both tumor&#xD;
      types including 6 PRs (partial response) and 3 SD (stable disease) in 11 patients with&#xD;
      metastatic breast cancer.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">February 12, 2015</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time to Disease Progression - Tumor Response based on RECIST criteria</measure>
    <time_frame>12 months</time_frame>
    <description>Measurement of tumors (sum of longest diameters) every 8 weeks for CT/MRI and photographs, and every 12 weeks for bone scan, if applicable.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Patients with Genetic Biomarker Expression in Tumor Tissue</measure>
    <time_frame>12 months</time_frame>
    <description>Formalin-fixed paraffin embedded tissue from study patients' primary breast cancers will be retrospectively analyzed for potential biomarkers including, but not limited to expression of forkhead box protein M1 (FOXM1) and Aurora kinase A (AURKA), p53 mutation status, and degree of genomic instability</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants with Serious and Non-Serious Adverse Events</measure>
    <time_frame>12 monrhs</time_frame>
    <description>Monitoring and recording of all adverse events and serious adverse events; regular monitoring of hematology, blood chemistry, regular measurement of vital signs, physical examination (including weight); and performance status.&#xD;
All patients who receive at least one dose of study drug will be evaluated for safety. Toxicities will be graded and reported according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03. Incidence and type of adverse events will be tabulated and summarized using descriptive statistics.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">175</enrollment>
  <condition>Breast Cancer</condition>
  <condition>Breast Carcinoma</condition>
  <condition>Breast Tumors</condition>
  <condition>Malignant Neoplasm of Breast</condition>
  <arm_group>
    <arm_group_label>ER+/HER2- Paclitaxel Alone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Paclitaxel 90 mg/m2 IV on days 1, 8 and 15 of a 28-day cycle</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ER+/HER2- Paclitaxel plus Alisertib</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Paclitaxel 60 mg/m2 intravenously (IV) on days 1, 8 and 15 of a 28-day cycle; Alisertib 40 mg BID on days 1-3, 8-10, and 15-17 of a 28-day cycle</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Triple Negative Paclitaxel Alone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Paclitaxel 90 mg/m2 IV on days 1, 8 and 15 of a 28-day cycle</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Triple Negative Paclitaxel plus Alisertib</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Paclitaxel 60 mg/m2 intravenously (IV) on days 1, 8 and 15 of a 28-day cycle; Alisertib 40 mg BID on days 1-3, 8-10, and 15-17 of a 28-day cycle</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Paclitaxel</intervention_name>
    <description>either 60 mg/m2 intravenously (IV) on days 1, 8 and 15 of a 28-day cycle (on Paclitaxel plus Alisertib arm) or 90 mg/m2 IV on days 1, 8 and 15 of a 28-day cycle (on Paclitaxel Alone arm)</description>
    <arm_group_label>ER+/HER2- Paclitaxel Alone</arm_group_label>
    <arm_group_label>ER+/HER2- Paclitaxel plus Alisertib</arm_group_label>
    <arm_group_label>Triple Negative Paclitaxel Alone</arm_group_label>
    <arm_group_label>Triple Negative Paclitaxel plus Alisertib</arm_group_label>
    <other_name>Taxol</other_name>
    <other_name>Abraxane</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Alisertib</intervention_name>
    <description>40 mg BID (twice a day) on days 1-3, 8-10, and 15-17 of a 28-day cycle</description>
    <arm_group_label>ER+/HER2- Paclitaxel plus Alisertib</arm_group_label>
    <arm_group_label>Triple Negative Paclitaxel plus Alisertib</arm_group_label>
    <other_name>MLN8237</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Voluntary written informed consent before performance of any study-related procedure&#xD;
             not part of normal medical care, with the understanding that consent may be withdrawn&#xD;
             by the subject at any time without prejudice to future medical care, and signed Health&#xD;
             Insurance Portability and Accountability Act (HIPAA) form.&#xD;
&#xD;
          -  Female subject (≥18 years old), who is either:&#xD;
&#xD;
               -  post-menopausal for at least one year before the screening visit, or&#xD;
&#xD;
               -  surgically sterilized, or&#xD;
&#xD;
               -  willing to use an acceptable method of birth control (i.e., a hormonal&#xD;
                  contraceptive, intra-uterine device, diaphragm with spermicide, or condom with&#xD;
                  spermicide) for the duration of the study.&#xD;
&#xD;
          -  Metastatic or locally recurrent breast cancer with histologic confirmation (on either&#xD;
             primary or metastatic tumor) of one of the following:&#xD;
&#xD;
               -  ER+, HER2- invasive breast cancer (any progesterone receptor [PgR] status)&#xD;
&#xD;
               -  Poorly differentiated and/or Grade 3 invasive TNBC, defined as:&#xD;
&#xD;
               -  HER2 negative status (based on most recently analyzed biopsy) is defined as&#xD;
                  immunohistochemistry (IHC) status of 0, 1+ or 2+ (if IHC 2+, a negative FISH test&#xD;
                  is required, i.e., HER2 fluorescence in situ hybridization (FISH) ratio &lt; 2.0&#xD;
                  with an average HER2 copy number &lt;4.0 signals/cell); ER-negative and PR-negative&#xD;
                  status is defined as ER and PgR &lt;1% nuclei positive by IHC&#xD;
&#xD;
          -  Measurable disease by modified Response Evaluation Criteria in Solid Tumors (RECIST)&#xD;
             (v1.1) or non-measurable lytic, bone-only disease (mixed blastic/lytic bone disease is&#xD;
             allowed); if patient has bone-predominant disease with no measurable disease, there&#xD;
             must be a lytic component to the bone metastases that is visible on plain X-ray or CT&#xD;
             scan that can be serially followed&#xD;
&#xD;
          -  Absolute neutrophil count (ANC) &gt; 1500/mm³, platelets &gt; 100,000/mm³, Hgb &gt; 9 g/dL.&#xD;
             Values must be obtained without need for myeloid growth factor or platelet transfusion&#xD;
             support within 14 days, however, erythrocyte growth factor is allowed as per published&#xD;
             American Society of Clinical Oncology (ASCO) guidelines (available at:&#xD;
             http://www.asco.org/quality-guidelines/asco-ash-clinical-practice-guideline-update-use&#xD;
             -epoetin-and-darbepoetin-adult).&#xD;
&#xD;
          -  Total bilirubin ≤ 1.5 x upper limit of normal (ULN), serum glutamic-oxaloacetic&#xD;
             transaminase (SGOT) (AST) and serum glutamic-pyruvic transaminase (SGPT) (ALT) &lt; 2.5 x&#xD;
             ULN. AST and/or ALT may be up to 5 x ULN if patient has known liver metastases&#xD;
&#xD;
          -  Adequate renal function as defined by: Calculated creatinine clearance must be ≥ 30&#xD;
             mL/minute (see Cockcroft-Gault formula in Appendix 5)&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 (refer to Appendix&#xD;
             4)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous radiation therapy covering the whole pelvis&#xD;
&#xD;
          -  Suspected brain metastases, untreated brain metastases or current clinical or&#xD;
             radiologic progression of known brain metastases or requirement for steroid therapy&#xD;
             for brain metastases&#xD;
&#xD;
               -  Patients with treated brain metastases are eligible if they have been stable and&#xD;
                  off steroids for ≥ 3 weeks&#xD;
&#xD;
          -  Prior allogeneic bone marrow or organ transplantation&#xD;
&#xD;
          -  Known GI disease or GI procedures that could interfere with the oral absorption or&#xD;
             tolerance of alisertib. Examples include, but are not limited to partial gastrectomy,&#xD;
             history of small intestine surgery, and celiac disease&#xD;
&#xD;
          -  Known history of uncontrolled sleep apnea syndrome and other conditions that could&#xD;
             result in excessive daytime sleepiness, such as severe chronic obstructive pulmonary&#xD;
             disease; requirement for supplemental oxygen.&#xD;
&#xD;
          -  Requirement for administration of proton pump inhibitor, or for constant&#xD;
             administration of H2 antagonist, or pancreatic enzymes. Intermittent uses of antacids&#xD;
             or H2 antagonists are allowed as described in Section 3.4.&#xD;
&#xD;
          -  Systemic infection requiring IV antibiotic therapy within 14 days preceding the first&#xD;
             dose of study drug, or other severe infection.&#xD;
&#xD;
          -  Myocardial infarction within 6 months prior to enrollment or has New York Heart&#xD;
             Association (NYHA) Class III or IV heart failure (see Appendix 3), uncontrolled&#xD;
             angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence&#xD;
             of acute ischemia or active conduction system abnormalities. Prior to study entry, any&#xD;
             ECG abnormality at Screening has to be documented by the investigator as not medically&#xD;
             relevant.&#xD;
&#xD;
          -  Female subject who is pregnant or breast-feeding. Confirmation that the subject is not&#xD;
             pregnant must be established by a negative serum B-human chorionic gonadotropin&#xD;
             (B-hCG) pregnancy test result obtained during screening, within 72 hours prior to&#xD;
             first dose of study drug(s). Pregnancy testing is not required for post-menopausal or&#xD;
             surgically sterilized women.&#xD;
&#xD;
          -  Patient has received an investigational agent within 30 days before enrollment&#xD;
&#xD;
          -  Serious medical or psychiatric illness likely to interfere with participation in this&#xD;
             clinical study.&#xD;
&#xD;
          -  Other severe acute or chronic medical and/or psychiatric condition(s), including but&#xD;
             not limited to uncontrolled diabetes, malabsorption, resection of the pancreas or&#xD;
             upper small bowel, requirement for pancreatic enzymes, any condition that would modify&#xD;
             small bowel absorption of oral medications, or laboratory abnormalities that may&#xD;
             increase the risk associated with study participation or investigational product&#xD;
             administration or may interfere with the interpretation of study results and, in the&#xD;
             judgment of the investigator, would make the patient not eligible for enrollment for&#xD;
             this study.&#xD;
&#xD;
          -  Diagnosed or treated for another malignancy within 3 years of enrollment, with the&#xD;
             exception of complete resection of basal cell carcinoma or squamous cell carcinoma of&#xD;
             the skin, or an in situ malignancy, or a stage I cancer with a 5-year Disease Free&#xD;
             Survival (DFS) of ≥ 90% (survival rates by stage are available for most cancers on the&#xD;
             American Cancer Society website).&#xD;
&#xD;
          -  Treatment with clinically significant enzyme inducers, such as the enzyme-inducing&#xD;
             antiepileptic drugs phenytoin, carbamazepine or phenobarbital, or rifampin, rifabutin,&#xD;
             rifapentine or St. John's wort within 14 days prior to the first dose of alisertib and&#xD;
             during the study.&#xD;
&#xD;
          -  Known history of human immunodeficiency virus (HIV) infection, hepatitis B, or&#xD;
             hepatitis C. Testing is not required in the absence of clinical findings or suspicion.&#xD;
             For guidance in defining active infection for hepatitis B, please refer to the WHO&#xD;
             guidelines. (World Health Organization, Global Alert and Response (GAR), Hepatitis B.&#xD;
             http://who.int/csr/disease/hepatitis/whocdscsrlyo20022/en/index4.html)&#xD;
&#xD;
          -  Prior administration of an Aurora A kinase-targeted agent, including alisertib&#xD;
&#xD;
          -  Need for ongoing therapeutic steroid therapy. Intermittent steroid use for the control&#xD;
             of nausea and vomiting is allowed. Premedication with dexamethasone prior to&#xD;
             paclitaxel administration is allowed. Topical steroid use is permitted. Inhaled&#xD;
             steroids are permitted. Replacement doses of hydrocortisone up to 15 mg/day are&#xD;
             allowed.&#xD;
&#xD;
          -  Inability to swallow oral medication or inability or unwillingness to comply with the&#xD;
             administration requirements related to alisertib.&#xD;
&#xD;
          -  Administration of myeloid growth factors or platelet transfusion within 14 days prior&#xD;
             to the first dose of study treatment.&#xD;
&#xD;
          -  More than 1 previous chemotherapy regimen for metastatic disease&#xD;
&#xD;
               -  No limit on previous endocrine therapy&#xD;
&#xD;
               -  Previous mammalian target of rapamycin (mTOR) therapy, e.g., everolimus, is&#xD;
                  allowed&#xD;
&#xD;
               -  Prior adjuvant taxane therapy is allowed, provided the disease-free interval from&#xD;
                  the end of (neo)adjuvant chemotherapy to the development of metastatic disease&#xD;
                  was ≥ 1 year&#xD;
&#xD;
               -  No prior taxane for metastatic disease&#xD;
&#xD;
          -  Peripheral neuropathy &gt; grade 1&#xD;
&#xD;
          -  Known severe hypersensitivity to paclitaxel&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joyce A. O'Shaughnessy, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>US Oncology Research, McKesson Specialty Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>22 Sites</name>
      <address>
        <city>Including Dallas And Austin</city>
        <state>Texas</state>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>July 6, 2014</study_first_submitted>
  <study_first_submitted_qc>July 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 11, 2014</study_first_posted>
  <last_update_submitted>August 10, 2023</last_update_submitted>
  <last_update_submitted_qc>August 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>metastatic breast cancer</keyword>
  <keyword>Human Epidermal Growth Factor Receptor 2-negative (HER2-) breast cancer</keyword>
  <keyword>Estrogen Receptor-positive (ER+) breast cancer</keyword>
  <keyword>Triple Negative breast cancer</keyword>
  <keyword>alisertib</keyword>
  <keyword>paclitaxel</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paclitaxel</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/NCT02187991
org study id: 13-033
nct id: NCT02187991
lead sponsor: 
collaborator: 
has dmc: Yes
The goal of this clinical research study is to learn if the study drug, alisertib, in
      combination with chemotherapy (paclitaxel), can shrink or slow tumor growth in women with
      hormone receptor (HR)-positive, HER2-negative or HR-negative, HER2-negative (triple negative)
      locally recurrent or metastatic breast cancer. The safety of alisertib in combination with
      paclitaxel will also be studied. The physical state of the patient, symptoms, changes in the
      size of the tumor, and laboratory findings obtained while on-study will help the research
      team decide if alisertib plus paclitaxel is safe and effective in patients with this type of
      breast cancer.

      Alisertib belongs to a group of drugs called Aurora kinase inhibitors. Alisertib blocks the
      activity of Aurora A kinase, a protein that is involved in tumor cell multiplication and
      survival. Aurora A kinase is expressed at higher than normal levels in many types of cancer,
      including breast cancer, and preclinical studies suggest that blocking the activity of this
      protein can lead to the death of cancer cells.

      Paclitaxel is a chemotherapy drug commonly used to treat many different kinds of cancer,
      including metastatic breast cancer. The reason to combine alisertib and paclitaxel is that in
      cancer therapy, combinations of drugs are often more effective as a treatment than either of
      the same drugs used alone.
The rationale behind assessing the effectiveness of the addition of alisertib to weekly
      paclitaxel therapy in patients with Triple Negative Breast Cancer and highly proliferative
      ER+ and HER2- breast cancer is based on the unmet clinical need for effective strategies to
      prevent or delay resistance to taxane therapy in the metastatic setting. Synergistic or
      additive effects have been observed in breast cancer xenograft models which involved
      alisertib added to either paclitaxel or docetaxel. Alisertib inhibited the Pgp-mediated
      efflux of paclitaxel in a cell culture model. In addition, Aurora Kinase A is frequently
      overexpressed in Triple Negative Breast Cancer (TNBC), and expression levels have been shown
      to be prognostic in both of these breast cancer subtypes. The combination of alisertib with
      paclitaxel has also been investigated in a Phase 1 study in patients with locally advanced or
      metastatic ovarian and breast cancers, with preliminary evidence of activity in both tumor
      types including 6 PRs (partial response) and 3 SD (stable disease) in 11 patients with
      metastatic breast cancer.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Time to Disease Progression - Tumor Response based on RECIST criteria
time frame: 12 months
description: Measurement of tumors (sum of longest diameters) every 8 weeks for CT/MRI and photographs, and every 12 weeks for bone scan, if applicable.
measure: Number of Patients with Genetic Biomarker Expression in Tumor Tissue
time frame: 12 months
description: Formalin-fixed paraffin embedded tissue from study patients' primary breast cancers will be retrospectively analyzed for potential biomarkers including, but not limited to expression of forkhead box protein M1 (FOXM1) and Aurora kinase A (AURKA), p53 mutation status, and degree of genomic instability
measure: Number of Participants with Serious and Non-Serious Adverse Events
time frame: 12 monrhs
description: Monitoring and recording of all adverse events and serious adverse events; regular monitoring of hematology, blood chemistry, regular measurement of vital signs, physical examination (including weight); and performance status.
All patients who receive at least one dose of study drug will be evaluated for safety. Toxicities will be graded and reported according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03. Incidence and type of adverse events will be tabulated and summarized using descriptive statistics.
arm group label: ER+/HER2- Paclitaxel Alone
arm group type: Active Comparator
description: Paclitaxel 90 mg/m2 IV on days 1, 8 and 15 of a 28-day cycle
arm group label: ER+/HER2- Paclitaxel plus Alisertib
arm group type: Experimental
description: Paclitaxel 60 mg/m2 intravenously (IV) on days 1, 8 and 15 of a 28-day cycle; Alisertib 40 mg BID on days 1-3, 8-10, and 15-17 of a 28-day cycle
arm group label: Triple Negative Paclitaxel Alone
arm group type: Active Comparator
description: Paclitaxel 90 mg/m2 IV on days 1, 8 and 15 of a 28-day cycle
arm group label: Triple Negative Paclitaxel plus Alisertib
arm group type: Experimental
description: Paclitaxel 60 mg/m2 intravenously (IV) on days 1, 8 and 15 of a 28-day cycle; Alisertib 40 mg BID on days 1-3, 8-10, and 15-17 of a 28-day cycle
intervention type: Drug
intervention name: Paclitaxel
description: either 60 mg/m2 intravenously (IV) on days 1, 8 and 15 of a 28-day cycle (on Paclitaxel plus Alisertib arm) or 90 mg/m2 IV on days 1, 8 and 15 of a 28-day cycle (on Paclitaxel Alone arm)
arm group label: ER+/HER2- Paclitaxel Alone
arm group label: ER+/HER2- Paclitaxel plus Alisertib
arm group label: Triple Negative Paclitaxel Alone
arm group label: Triple Negative Paclitaxel plus Alisertib
other name: Taxol
other name: Abraxane
intervention type: Drug
intervention name: Alisertib
description: 40 mg BID (twice a day) on days 1-3, 8-10, and 15-17 of a 28-day cycle
arm group label: ER+/HER2- Paclitaxel plus Alisertib
arm group label: Triple Negative Paclitaxel plus Alisertib
other name: MLN8237
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Joyce A. O'Shaughnessy, MD
role: Principal Investigator
affiliation: US Oncology Research, McKesson Specialty Health
facility: 
country: United States
responsible party type: Sponsor
mesh term: Breast Neoplasms
mesh term: Neoplasms
mesh term: Paclitaxel