<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/NCT03236974</url>
  </required_header>
  <id_info>
    <org_study_id>D6090C00002</org_study_id>
    <nct_id>NCT03236974</nct_id>
  </id_info>
  <brief_title>Study to Compare the Effects of AZD9496 vs Fulvestrant in Breast Cancer.</brief_title>
  <acronym>D6090C00002</acronym>
  <official_title>An Open Label, Randomised, Pre-surgical, Pharmacodynamics Study to Compare the Biological Effects of AZD9496 Versus Fulvestrant in Postmenopausal Women With ER Positive HER-2 Negative Primary Breast Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AstraZeneca</source>
  <oversight_info>
    <has_dmc>Yes</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 an open label randomised multicentre pre-surgical pharmacodynamics study to compare&#xD;
      and assess the biological effects of AZD9496 and fulvestrant in postmenopausal women with&#xD;
      estrogen receptor (ER) positive (ER+), human epidermal growth factor receptor 2 (HER-2)&#xD;
      negative (HER2-) primary breast cancer.&#xD;
&#xD;
      Patients will receive AZD9496 or fulvestrant and will have an on-treatment image&#xD;
&#xD;
      -guided core biopsy after 5-14 days of commencing treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an open label, randomized, multi-centre study in postmenopausal women with primary&#xD;
      ER+ HER2- breast cancer. Patients will be randomised to an oral dose of 250 mg bd AZD9496 or&#xD;
      500mg fulvestrant i.m. administered on one occasion. Patients diagnosed with primary breast&#xD;
      cancer who are scheduled for surgery with curative intent will be consented to the study&#xD;
      including consent to use the formalin fixed paraffin embedded (FFPE) diagnostic tumor biopsy&#xD;
      sample and fresh frozen tumor biopsy sample (if available) for research purposes. Patients&#xD;
      may also consent to provide an optional pretreatment fresh frozen tumor biopsy sample if this&#xD;
      was not obtained at the time of initial diagnostic biopsy. If the diagnostic biopsy was taken&#xD;
      ≥ 6 weeks prior to starting treatment or was not of sufficient quality, new tumor core&#xD;
      biopsies (FFPE and fresh frozen) must be taken. Following the screening visit, eligible&#xD;
      patients will be randomised to receive one of the following study treatments:&#xD;
&#xD;
        -  AZD9496 administered at 250 mg bd orally for 5-14 days commencing on Day 1, and&#xD;
           continuing up to the day of biopsy OR&#xD;
&#xD;
        -  fulvestrant 500 mg administered as two consecutive 5 ml intramuscular injections on Day&#xD;
           1, one in each buttock.&#xD;
&#xD;
      After the morning dose of AZD9496 on the day of biopsy dosing will be stopped. If following&#xD;
      initiation of AZD9496 treatment, dosing will be stopped if biopsy is postponed beyond Day 14.&#xD;
      Patients will be considered not evaluable for the study if biopsy is postponed beyond day 14&#xD;
      of AZD9496/fulvestrant treatment initiation. Core tumor biopsies will be taken at either the&#xD;
      time of definitive surgery or at a separate visit prior to surgery in the period between (and&#xD;
      including) day 5 and day 14. Subjects who are scheduled to start a subsequent neoadjuvant&#xD;
      therapy must have their core tumor biopsies performed before commencing neoadjuvant&#xD;
      treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 5, 2017</start_date>
  <completion_date type="Actual">February 12, 2019</completion_date>
  <primary_completion_date type="Actual">February 12, 2019</primary_completion_date>
  <phase>Phase 1</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>
    <masking_description>Not applicable, thisis an open-label study.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Pharmacodynamics changes to estrogen receptor (ER) expression following treatment with AZD9496 or fulvestrant</measure>
    <time_frame>Tumour biopsy taken at baseline within 6 weeks of planned start of study treatment; on-treatment tumour biopsy taken following 5-14 day on study treatment</time_frame>
    <description>Evaluation of AZD9496 and fulvestrant activity in the tumour by assessment of pharmacodynamics biomarker changes i.e. ER expression</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pharmacodynamics changes to progesterone receptor (PgR) expression following treatment with AZD9496 or fulvestrant</measure>
    <time_frame>Tumour biopsy taken at baseline within 6 weeks of planned start of study treatment; on-treatment tumour biopsy taken following 5-14 day on study treatment</time_frame>
    <description>Evaluation of AZD9496 and fulvestrant activity in the tumour by assessment of pharmacodynamics biomarker changes i.e. PgR expression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacodynamics changes to Ki67 protein biomarker expression following treatment with AZD9496 or fulvestrant</measure>
    <time_frame>Tumour biopsy taken at baseline within 6 weeks of planned start of study treatment; on-treatment tumour biopsy taken following 5-14 day on study treatment</time_frame>
    <description>Evaluation of AZD9496 and fulvestrant activity in the tumour by assessment of pharmacodynamics biomarker changes i.e. Ki67 protein biomarker expression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety and tolerability of AZD9496</measure>
    <time_frame>From first dose until 28 days after last dose of AZD9496</time_frame>
    <description>Safety and tolerability will be assessed in terms of adverse events (AEs), laboratory data, vital signs and ECG changes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety and tolerability of fulvestrant</measure>
    <time_frame>From first dose until 28 days after fulvestrant</time_frame>
    <description>Safety and tolerability will be assessed in terms of adverse events (AEs), laboratory data and vital signs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma concentration of AZD9496 - stand alone biopsy visit option</measure>
    <time_frame>Blood samples collected close as possible to time of biopsy, 1-2 hours after biopsy and optional 3-4 hours after biopsy</time_frame>
    <description>Determination of AZD9496 concentrations in plasma</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma concentration of fulvestrant</measure>
    <time_frame>A blood sample will be collected anytime before biopsy.</time_frame>
    <description>Determination of fulvestrant concentration in plasma</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plasma concentration of AZD9496 - on the table biopsy option</measure>
    <time_frame>Blood samples collected close as possible to time of biopsy, at least 2 hours after biopsy and 8-12 hours after last dose or at discharge which is defined as up to 12 hours after last dose</time_frame>
    <description>Determination of AZD9496 concentration in plasma</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">49</enrollment>
  <condition>Postmenopausal Women With ER+ HER2- Primary Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Standard arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Fulvestrant, 500 mg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AZD9496</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>250 mg bd taken orally for 5-14 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Standard Arm - Fulvestrant</intervention_name>
    <description>500 mg Fulvestrant administered as two consecutive 5 ml intramuscular injections on Day 1, one in each buttock</description>
    <arm_group_label>Standard arm</arm_group_label>
    <other_name>Fulvestrant</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AZD9496</intervention_name>
    <description>Administered at 250 mg bd orally for 5-14 days commencing on Day 1, and continuing up to the day of biopsy</description>
    <arm_group_label>AZD9496</arm_group_label>
    <other_name>Study drug</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          1. Signed and dated informed consent form (ICF)&#xD;
&#xD;
          2. Women &gt;=18 years&#xD;
&#xD;
          3. Patients with newly diagnosed resectable primary breast cancer scheduled to undergo&#xD;
             treatment with curative intent by surgery&#xD;
&#xD;
          4. Histologically confirmed invasive breast cancer involving a palpable tumor of any&#xD;
             size, or a tumor with an ultrasound assessed diameter of ≥ 1.0 cm&#xD;
&#xD;
          5. Any clinical nodal status&#xD;
&#xD;
          6. ER+breast cancer&#xD;
&#xD;
          7. HER2- breast cancer defined as a negative in situ hybridization test or an&#xD;
             immno-histochemistry (IHC) status of 0 or 1+&#xD;
&#xD;
          8. Eastern Co-operative Oncology group (ECOG) performance status 0-1&#xD;
&#xD;
          9. Post-menopausal status defined as meeting at least one of the following criteria: Have&#xD;
             undergone a bilateral oophorectomy; Age ≥60 years; Age ≥50 years and with cessation of&#xD;
             regular menses ≥12 months and with an intact uterus in the absence of oral&#xD;
             contraception or hormone-replacement therapy (HRT) prior to the diagnosis of breast&#xD;
             cancer; Age &lt;60 years and with cessation of regular menses ≥12 months and follicle&#xD;
             stimulating hormone (FSH) and oestradiol levels in the postmenopausal range&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          1. Pre-treatment biopsy sample not likely to provide adequate tissue sections for the&#xD;
             biomarker assays&#xD;
&#xD;
          2. Previous systemic or local treatment for the new primary breast cancer currently under&#xD;
             investigation (including surgery, radiotherapy, cytotoxic and endocrine treatments)&#xD;
&#xD;
          3. Inflammatory breast cancer&#xD;
&#xD;
          4. Evidence of metastases&#xD;
&#xD;
          5. Patients currently receiving medications or herbal supplements known to be strong&#xD;
             inhibitors/inducers of CYP3A4/5 or strong inhibitors of CYP2C8 or that are sensitive&#xD;
             substrates of CYP2C8 inhibition&#xD;
&#xD;
          6. Concurrent treatment with other experimental drugs within 4 weeks prior to receiving&#xD;
             study treatment&#xD;
&#xD;
          7. Use of hormone-replacement therapy from &lt;4 weeks of the diagnostic/baseline core&#xD;
             biopsy to the start of trial treatment&#xD;
&#xD;
          8. Patients with second primary cancer. Any endocrine therapies or other anti-cancer&#xD;
             therapies must have been ceased at least 12 months prior to enrollment.&#xD;
&#xD;
          9. Any of the following cardiac criteria:&#xD;
&#xD;
               -  Mean resting QT interval corrected for heart rate (QTc) &gt; 470 msec obtained from&#xD;
                  3 ECGs using Fridericia's formula&#xD;
&#xD;
               -  Any clinically important abnormalities in rhythm, conduction or morphology of&#xD;
                  resting ECG&#xD;
&#xD;
               -  Any factors that increase the risk of QTc prolongation or risk of arrhythmic&#xD;
                  events&#xD;
&#xD;
         10. Experience of any of the following in the preceding 6 months: coronary artery bypass&#xD;
             graft (CABG), angioplasty, vascular stent, myocardial infarction (MI), angina&#xD;
             pectoris, congestive heart failure New York Heart Association (NYHA) Grade ≥2,&#xD;
             cerebrovascular accident (CVA), transient ischaemic attack (TIA), deep venous or&#xD;
             arterial thrombosis, pulmonary embolism, bleeding diathesis (i.e., disseminated&#xD;
             intravascular coagulation, clotting factor deficiency) or requirement of anticoagulant&#xD;
             therapy&#xD;
&#xD;
         11. As judged by the Investigator, any evidence of severe or uncontrolled systemic&#xD;
             diseases,&#xD;
&#xD;
         12. Uncontrolled symptomatic thyroid dysfunction (hyperthyroidism or hypothyroidism).&#xD;
&#xD;
         13. Unexplained symptomatic endometrial disorders.&#xD;
&#xD;
         14. Refractory nausea and vomiting, uncontrolled chronic GI diseases, inability to swallow&#xD;
             the formulated product or previous significant bowel resection that would preclude&#xD;
             adequate absorption of AZD9496.&#xD;
&#xD;
         15. Inadequate bone marrow reserve or organ function as demonstrated by any of the&#xD;
             following laboratory values: absolute neutrophil count &lt; 1.5 x 109/L, Platelet count &lt;&#xD;
             100 x 109/L, Haemoglobin &lt; 90 g/L, alanine aminotransferase (ALT) &gt; 2.5x upper limit&#xD;
             of normal (ULN), aspartate aminotransferase (AST) &gt; 2.5 x ULN, Total bilirubin &gt; 1.5 x&#xD;
             ULN or &gt; 3 x in case of Gilbert's Syndrome, glomerular filtration rate &lt; 50 mL/min&#xD;
&#xD;
         16. Direct involvement in the planning and conduct of the study&#xD;
&#xD;
         17. History of hypersensitivity to AZD9496&#xD;
&#xD;
         18. History of hypersensitivity to fulvestrant and/or castor oil&#xD;
&#xD;
         19. Judgment by the investigator that the patient should not participate in the study if&#xD;
             unlikely to comply with study procedures, restrictions and requirements In addition,&#xD;
             the following is considered a criterion for exclusion from the exploratory genetic&#xD;
             research: Previous allogeneic bone marrow transplant; Non-leukocyte depleted whole&#xD;
             blood transfusion within 120 days of the date of the genetic sample collection&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>120 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Erlangen</city>
        <zip>91054</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Minden</city>
        <zip>32429</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>München</city>
        <zip>81377</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Schwerin</city>
        <zip>19049</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Derby</city>
        <zip>DE22 3DT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Edinburgh</city>
        <zip>EH4 2XU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>London</city>
        <zip>EC1M 6BQ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>London</city>
        <zip>SE1 9RT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>London</city>
        <zip>W12 0NN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Manchester</city>
        <zip>M23 9LT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Poole</city>
        <zip>BH15 2JB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Sutton In Ashfield</city>
        <zip>NG17 4JL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
    <country>United Kingdom</country>
  </location_countries>
  <link>
    <url>https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Search</url>
    <description>Results of this clinical trial are available on www.astrazenecaclinicaltrials.com</description>
  </link>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>July 18, 2017</study_first_submitted>
  <study_first_submitted_qc>August 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 2, 2017</study_first_posted>
  <last_update_submitted>February 5, 2020</last_update_submitted>
  <last_update_submitted_qc>February 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 6, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fulvestrant</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03236974
org study id: D6090C00002
nct id: NCT03236974
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This is an open label randomised multicentre pre-surgical pharmacodynamics study to compare
      and assess the biological effects of AZD9496 and fulvestrant in postmenopausal women with
      estrogen receptor (ER) positive (ER+), human epidermal growth factor receptor 2 (HER-2)
      negative (HER2-) primary breast cancer.

      Patients will receive AZD9496 or fulvestrant and will have an on-treatment image

      -guided core biopsy after 5-14 days of commencing treatment.
This is an open label, randomized, multi-centre study in postmenopausal women with primary
      ER+ HER2- breast cancer. Patients will be randomised to an oral dose of 250 mg bd AZD9496 or
      500mg fulvestrant i.m. administered on one occasion. Patients diagnosed with primary breast
      cancer who are scheduled for surgery with curative intent will be consented to the study
      including consent to use the formalin fixed paraffin embedded (FFPE) diagnostic tumor biopsy
      sample and fresh frozen tumor biopsy sample (if available) for research purposes. Patients
      may also consent to provide an optional pretreatment fresh frozen tumor biopsy sample if this
      was not obtained at the time of initial diagnostic biopsy. If the diagnostic biopsy was taken
      ≥ 6 weeks prior to starting treatment or was not of sufficient quality, new tumor core
      biopsies (FFPE and fresh frozen) must be taken. Following the screening visit, eligible
      patients will be randomised to receive one of the following study treatments:

        -  AZD9496 administered at 250 mg bd orally for 5-14 days commencing on Day 1, and
           continuing up to the day of biopsy OR

        -  fulvestrant 500 mg administered as two consecutive 5 ml intramuscular injections on Day
           1, one in each buttock.

      After the morning dose of AZD9496 on the day of biopsy dosing will be stopped. If following
      initiation of AZD9496 treatment, dosing will be stopped if biopsy is postponed beyond Day 14.
      Patients will be considered not evaluable for the study if biopsy is postponed beyond day 14
      of AZD9496/fulvestrant treatment initiation. Core tumor biopsies will be taken at either the
      time of definitive surgery or at a separate visit prior to surgery in the period between (and
      including) day 5 and day 14. Subjects who are scheduled to start a subsequent neoadjuvant
      therapy must have their core tumor biopsies performed before commencing neoadjuvant
      treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
masking description: Not applicable, thisis an open-label study.
measure: Pharmacodynamics changes to estrogen receptor (ER) expression following treatment with AZD9496 or fulvestrant
time frame: Tumour biopsy taken at baseline within 6 weeks of planned start of study treatment; on-treatment tumour biopsy taken following 5-14 day on study treatment
description: Evaluation of AZD9496 and fulvestrant activity in the tumour by assessment of pharmacodynamics biomarker changes i.e. ER expression
measure: Pharmacodynamics changes to progesterone receptor (PgR) expression following treatment with AZD9496 or fulvestrant
time frame: Tumour biopsy taken at baseline within 6 weeks of planned start of study treatment; on-treatment tumour biopsy taken following 5-14 day on study treatment
description: Evaluation of AZD9496 and fulvestrant activity in the tumour by assessment of pharmacodynamics biomarker changes i.e. PgR expression
measure: Pharmacodynamics changes to Ki67 protein biomarker expression following treatment with AZD9496 or fulvestrant
time frame: Tumour biopsy taken at baseline within 6 weeks of planned start of study treatment; on-treatment tumour biopsy taken following 5-14 day on study treatment
description: Evaluation of AZD9496 and fulvestrant activity in the tumour by assessment of pharmacodynamics biomarker changes i.e. Ki67 protein biomarker expression
measure: Safety and tolerability of AZD9496
time frame: From first dose until 28 days after last dose of AZD9496
description: Safety and tolerability will be assessed in terms of adverse events (AEs), laboratory data, vital signs and ECG changes.
measure: Safety and tolerability of fulvestrant
time frame: From first dose until 28 days after fulvestrant
description: Safety and tolerability will be assessed in terms of adverse events (AEs), laboratory data and vital signs
measure: Plasma concentration of AZD9496 - stand alone biopsy visit option
time frame: Blood samples collected close as possible to time of biopsy, 1-2 hours after biopsy and optional 3-4 hours after biopsy
description: Determination of AZD9496 concentrations in plasma
measure: Plasma concentration of fulvestrant
time frame: A blood sample will be collected anytime before biopsy.
description: Determination of fulvestrant concentration in plasma
measure: Plasma concentration of AZD9496 - on the table biopsy option
time frame: Blood samples collected close as possible to time of biopsy, at least 2 hours after biopsy and 8-12 hours after last dose or at discharge which is defined as up to 12 hours after last dose
description: Determination of AZD9496 concentration in plasma
arm group label: Standard arm
arm group type: Active Comparator
description: Fulvestrant, 500 mg
arm group label: AZD9496
arm group type: Experimental
description: 250 mg bd taken orally for 5-14 days
intervention type: Drug
intervention name: Standard Arm - Fulvestrant
description: 500 mg Fulvestrant administered as two consecutive 5 ml intramuscular injections on Day 1, one in each buttock
arm group label: Standard arm
other name: Fulvestrant
intervention type: Drug
intervention name: AZD9496
description: Administered at 250 mg bd orally for 5-14 days commencing on Day 1, and continuing up to the day of biopsy
arm group label: AZD9496
other name: Study drug
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 120 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Germany
country: United Kingdom
url: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Search
description: Results of this clinical trial are available on www.astrazenecaclinicaltrials.com
responsible party type: Sponsor
mesh term: Breast Neoplasms
mesh term: Fulvestrant
sharing ipd: Undecided