<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/NCT02970682</url>
  </required_header>
  <id_info>
    <org_study_id>EVG001BC</org_study_id>
    <nct_id>NCT02970682</nct_id>
  </id_info>
  <brief_title>SFX-01 in the Treatment and Evaluation of Metastatic Breast Cancer</brief_title>
  <acronym>STEM</acronym>
  <official_title>STEM: A Multicentre Phase 2 Study of SFX-01 Treatment and Evaluation in Patients With Estrogen Receptor (ER) Positive and Human Epidermal Growth Factor Receptor 2 (HER2) Negative Metastatic Breast Cancer Progressing on Either an Aromatase Inhibitor (AI) or Tamoxifen or Fulvestrant</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Evgen Pharma</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Premier Research Group plc</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Evgen Pharma</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a Phase 2 study to demonstrate the safety and efficacy of SFX-01 when used in&#xD;
      combination with aromatase inhibitors (AIs), tamoxifen and fulvestrant.&#xD;
&#xD;
      Patients will be enrolled into one of three study arms (SFX-01 in combination with AI,&#xD;
      tamoxifen or fulvestrant) based on their current therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The trial is a phase 2, parallel group design in patients with ER positive metastatic breast&#xD;
      cancer.&#xD;
&#xD;
      This study will be a multicentre study conducted over an 18 month period. Patients who are&#xD;
      taking either a third generation AI, tamoxifen or fulvestrant and have a documented evidence&#xD;
      of progressive disease after achieving a best response of stable disease (for at least 6&#xD;
      months) or an objective response of CR or PR on the current treatment indicating the&#xD;
      development of secondary resistance to current therapy will be entered into the study having&#xD;
      undergone a screening period to continue receiving the same treatment with the addition of&#xD;
      SFX-01.&#xD;
&#xD;
      At least 60 patients will be enrolled into one of three arms in a 1:1:1 ratio, i.e. 20&#xD;
      patients per arm. Enrolment will be based on current treatment.&#xD;
&#xD;
      Treatment Arm A: All patients will continue to receive their AI and, at the start of the&#xD;
      study (D1), patients will additionally take SFX-01.&#xD;
&#xD;
      Treatment Arm B: All patients will continue to receive tamoxifen and, at the start of the&#xD;
      study (D1), patients will additionally take SFX-01&#xD;
&#xD;
      Treatment Arm C: All patients will continue to receive fulvestrant 500 mg IM in 28 day Cycles&#xD;
      and, at the start of the study (D1), patients will additionally take SFX-01.&#xD;
&#xD;
      Patient participation will include a Screening Phase, a Treatment Phase, and a Follow-up&#xD;
      Phase of up to 28 weeks post D1 of dosing. The Screening Phase will be up to 28 days prior to&#xD;
      enrolment. The Treatment Phase will extend from enrolment until the patient is discontinued&#xD;
      from study treatment. The Follow-up Phase will be a maximum of 28 weeks and extend from the&#xD;
      time of study entry until 30 days after the patient discontinues trial therapy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2016</start_date>
  <completion_date type="Actual">March 2019</completion_date>
  <primary_completion_date type="Actual">January 2019</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Treatment-Emergent Adverse Events [Safety and Tolerability])</measure>
    <time_frame>28 weeks</time_frame>
    <description>To determine the safety and tolerability of SFX-01 in combination with AI, tamoxifen and fulvestrant</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical benefit rate</measure>
    <time_frame>24 weeks</time_frame>
    <description>To determine clinical benefit rate (CBR) (CR+PR+SD) at 24 weeks using RECIST v1.1</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Objective Response rate</measure>
    <time_frame>24 Weeks</time_frame>
    <description>To determine objective response rate (ORR) (CR+PR) at 24 weeks using RECIST v1.1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time To Response</measure>
    <time_frame>24 weeks</time_frame>
    <description>To determine time to response</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Progression</measure>
    <time_frame>24 Weeks</time_frame>
    <description>To determine time to progression (TTP)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression Free Survival</measure>
    <time_frame>24 Weeks</time_frame>
    <description>To determine progression free survival (PFS) at 24 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>24 Weeks</time_frame>
    <description>To determine overall survival (OS) at 24 weeks</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Benefit</measure>
    <time_frame>24 Weeks</time_frame>
    <description>To determine clinical benefit by measuring duration of response compared to duration of response to prior ET</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to next Treatment</measure>
    <time_frame>24 weeks</time_frame>
    <description>To determine time to next treatment</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Breast Neoplasm</condition>
  <arm_group>
    <arm_group_label>Aromatase Inhibitor</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SFX-01 with Aromatase Inhibitor SFX-01 when used in combination with aromatase inhibitors. All patients will continue to receive their AI and, at the start of the study (D1), patients will take SFX-01, which is provided as 300 mg capsules, one to be taken twice daily, 12 hours apart, after food (preferably within 2 hours).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fulvestrant</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SFX-01 with Fulvestrant SFX-01 when used in combination with fulvestrant. All patients will continue to receive fulvestrant 500 mg IM in 28 day cycles. As patients will already have been taking this, a repeat loading dose is not necessary. Commencing on study D1 patients will take SFX-01, which is provided as 300 mg capsules, one to be taken twice daily, 12 hours apart, after food (preferably within 2 hours).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tamoxifen</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SFX-01 with Tamoxifen SFX-01 when used in combination with tamoxifen All patients will continue to receive tamoxifen and, at the start of the study (D1), patients will take SFX-01, which is provided as 300 mg capsules, one to be taken twice daily, 12 hours apart after food (preferably within 2 hours).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SFX-01</intervention_name>
    <description>Stabilised Sulforaphane</description>
    <arm_group_label>Aromatase Inhibitor</arm_group_label>
    <arm_group_label>Fulvestrant</arm_group_label>
    <arm_group_label>Tamoxifen</arm_group_label>
    <other_name>Sulforadex</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fulvestrant</intervention_name>
    <description>Fulvestrant</description>
    <arm_group_label>Fulvestrant</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tamoxifen</intervention_name>
    <description>Tamoxifen</description>
    <arm_group_label>Tamoxifen</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Aromatase Inhibitors</intervention_name>
    <arm_group_label>Aromatase Inhibitor</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female patients 18 years or older (the patient must be the legal age limit to&#xD;
             give informed consent within the jurisdiction the study is taking place in);&#xD;
&#xD;
          2. Patients with histologically confirmed estrogen receptor positive (ER+) breast cancer.&#xD;
             ER is considered positive if a percentage score of ≥10% of tumour cells staining&#xD;
             positive for ER;&#xD;
&#xD;
          3. Histological confirmation of HER2 negative breast cancer on primary tumour at&#xD;
             diagnosis or on biopsy of a metastasis. HER2 negative is defined by the ASCO/CAP&#xD;
             guidelines;&#xD;
&#xD;
          4. Patients with clinical or histological confirmation of metastatic or locally advanced&#xD;
             disease not amenable to curative surgical resection;&#xD;
&#xD;
          5. Patients must have at least one site of measurable disease, defined as at least one&#xD;
             lesion that can be accurately measured in at least one dimension (longest diameter to&#xD;
             be recorded) ≥ 10 mm with spiral CT scan or MRI scan (malignant lymph nodes should be&#xD;
             ≥15mm to be considered measurable); all sites of disease should be noted and followed&#xD;
             in accordance with RECIST v1.1. (A lytic or mixed lytic-blastic bone lesion with a&#xD;
             soft tissue component assessed on CT/MRI can be measurable if the minimum size&#xD;
             criteria are met. Blastic bone lesions and bone lesions assessed on bone scan,&#xD;
             positron emission therapy (PET) or plain films are non-measurable);&#xD;
&#xD;
          6. Patients must have an anticipated life expectancy of at least 12 weeks;&#xD;
&#xD;
          7. Adequate bone marrow, renal and hepatic function defined as:&#xD;
&#xD;
               -  Haemoglobin &gt; 9 g/dL;&#xD;
&#xD;
               -  Absolute neutrophil count &gt; 1.0 x 109/L;&#xD;
&#xD;
               -  Platelets &gt; 100 x 109/L;&#xD;
&#xD;
               -  Total bilirubin within normal limits, except those with Gilberts syndrome for&#xD;
                  whom this must be &lt;2.5 x ULN;&#xD;
&#xD;
               -  AST(SGOT) or ALT(SGPT) &lt; 2.5 x ULN;&#xD;
&#xD;
               -  Calculated creatinine clearance &gt; 30 ml/min (Appendix 2);&#xD;
&#xD;
          8. Eastern Cooperative Oncology Group (ECOG) performance status &lt; 2;&#xD;
&#xD;
          9. Must currently be on either a third generation aromatase inhibitor, tamoxifen or&#xD;
             fulvestrant and have a documented evidence of progressive disease after:&#xD;
&#xD;
               1. taking ET as adjuvant therapy for &gt;2 years or&#xD;
&#xD;
               2. achieving a best response of stable disease (for at least 6 months) or an&#xD;
                  objective response of CR or PR on the current treatment both indicating the&#xD;
                  development of secondary resistance to current therapy;&#xD;
&#xD;
         10. Suitable for continuing endocrine therapy according to the treating clinician. The&#xD;
             window of discontinuation must not exceed 4 weeks.&#xD;
&#xD;
         11. All patients (or their legally acceptable representatives) must have signed an&#xD;
             informed consent document indicating that they understand the purpose of and&#xD;
             procedures required for the study and are willing to participate in the study.&#xD;
&#xD;
         12. No more than 3 lines of endocrine therapy for metastatic/locally advanced breast&#xD;
             cancer including the treatment that the patient is receiving at the time of study&#xD;
             entry. This can include targeted agents alongside endocrine therapy such as, but not&#xD;
             limited to, everolimus and palbociclib. Ovarian function suppression therapy is not an&#xD;
             exclusion for females who are premenopausal and on an ET that can be continued&#xD;
             throughout the study.&#xD;
&#xD;
         13. No more than one prior line of chemotherapy/targeted therapy for metastatic/locally&#xD;
             advanced breast cancer.&#xD;
&#xD;
         14. Patients with adequately controlled hepatitis C or hepatitis B surface antigen.&#xD;
&#xD;
         15. No residual toxicity &gt; grade 1 from prior antineoplastic therapy with the exception of&#xD;
             peripheral neuropathy or neuropathic pain which must be stable (as per investigator&#xD;
             assessment);&#xD;
&#xD;
         16. Sexually active male and female patients of childbearing potential must agree to use&#xD;
             an effective method of birth control (e.g., barrier methods with spermicides, oral or&#xD;
             parenteral contraceptives and/or intrauterine devices) during the entire duration of&#xD;
             the study and for 6 months after final administration of study drug. Note that&#xD;
             sterility in female patients must be confirmed in the patients' medical records and be&#xD;
             defined as any of the following: surgical hysterectomy or bilateral oophorectomy,&#xD;
             bilateral tubular ligation, natural menopause with last menses &gt;1 year ago; radiation&#xD;
             induced oophorectomy with last menses &gt;1 year ago; chemotherapy induced menopause with&#xD;
             1 year interval since last menses; male patients whose female partner(s) is (are)&#xD;
             pregnant must use a condom from the time of the first administration of SFX-01 until 3&#xD;
             months following administration of last dose;&#xD;
&#xD;
         17. Female patients of childbearing potential must have a negative serum or urine&#xD;
             pregnancy test at day 1 of the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Rapidly progressive visceral disease not suitable for further endocrine therapy;&#xD;
&#xD;
          2. Currently on chemotherapy or any other combination treatment for their MBC other than&#xD;
             AI, tamoxifen or fulvestrant;&#xD;
&#xD;
          3. Radiotherapy less than 2 weeks prior to study entry;&#xD;
&#xD;
          4. Major surgery (excluding placement of vascular access) within 4 weeks before the first&#xD;
             dose of study treatment;&#xD;
&#xD;
          5. Spinal cord compression or brain metastases unless treated and radiologically stable&#xD;
             for &gt; 6weeks post treatment and not requiring steroids for at least 4 weeks prior to&#xD;
             start of study treatment;&#xD;
&#xD;
          6. As judged by the Investigator, any evidence of severe or uncontrolled systemic&#xD;
             diseases, including active infection including hepatitis B, hepatitis C and human&#xD;
             immunodeficiency virus (HIV). Screening for chronic conditions is not required;&#xD;
&#xD;
          7. Refractory nausea and vomiting, patients with malabsorption syndrome, diseases&#xD;
             significantly affecting gastrointestinal function, resection of the stomach or small&#xD;
             bowel, or difficulty in swallowing and retaining oral medications;&#xD;
&#xD;
          8. An existing serious disease, illness, or condition that will prevent participation or&#xD;
             compliance with study procedures;&#xD;
&#xD;
          9. Patients with unresolved or unstable serious toxicity from prior administration of&#xD;
             another investigational drug and/or prior cancer treatment;&#xD;
&#xD;
         10. Diagnosed or treated for a malignancy other than breast cancer within 1 year, or who&#xD;
             were previously diagnosed with a malignancy other than breast cancer and have any&#xD;
             radiographic or biochemical marker evidence of malignancy. Patients with completely&#xD;
             resected basal cell carcinoma, squamous cell carcinoma of the skin, or in situ&#xD;
             malignancy (other than breast) are not excluded.&#xD;
&#xD;
         11. Concurrent treatment with another investigational agent or participated in another&#xD;
             investigational trial unless adequate washout period per the investigational drug PK&#xD;
             has been achieved (usually this is 5 half lives of a product);&#xD;
&#xD;
         12. Females who are pregnant, wishing to become pregnant or breast feeding.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sacha Howell, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Christie NHS Foundation Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Grand Hopital de Charleroi, Service D'Oncologie-Hematologie</name>
      <address>
        <city>Charleroi</city>
        <zip>6000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint-Luc hospital, Brussels</name>
      <address>
        <city>Woluwe-Saint-Lambert</city>
        <zip>1200</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ICO René Gauducheau, St Herblain</name>
      <address>
        <city>Nantes</city>
        <state>Loire Atlantique</state>
        <zip>44805</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Granollers Hospital, Granollers,</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Ramon Y Cajal</name>
      <address>
        <city>Madrid</city>
        <zip>100</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Christie NHS Foundation Trust</name>
      <address>
        <city>Manchester</city>
        <state>Greater Manchester</state>
        <zip>M20 4BX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospitals Birmingham NHS Foundation</name>
      <address>
        <city>Birmingham</city>
        <zip>B15 2TH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Bournemouth &amp; Christchurch Hospitals NHS</name>
      <address>
        <city>Bournemouth</city>
        <zip>BH7 7DW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Academic unit of Clinical Oncology</name>
      <address>
        <city>Sheffield</city>
        <zip>S10 2SJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Albert &amp; Edward Infirmary</name>
      <address>
        <city>Wigan</city>
        <zip>WN1 2WN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>France</country>
    <country>Spain</country>
    <country>United Kingdom</country>
  </location_countries>
  <removed_countries>
    <country>Czech Republic</country>
  </removed_countries>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>November 15, 2016</study_first_submitted>
  <study_first_submitted_qc>November 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2016</study_first_posted>
  <last_update_submitted>July 11, 2019</last_update_submitted>
  <last_update_submitted_qc>July 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 12, 2019</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>Tamoxifen</mesh_term>
    <mesh_term>Fulvestrant</mesh_term>
    <mesh_term>Aromatase Inhibitors</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/NCT02970682
org study id: EVG001BC
nct id: NCT02970682
lead sponsor: 
collaborator: 
has dmc: No
This is a Phase 2 study to demonstrate the safety and efficacy of SFX-01 when used in
      combination with aromatase inhibitors (AIs), tamoxifen and fulvestrant.

      Patients will be enrolled into one of three study arms (SFX-01 in combination with AI,
      tamoxifen or fulvestrant) based on their current therapy.
The trial is a phase 2, parallel group design in patients with ER positive metastatic breast
      cancer.

      This study will be a multicentre study conducted over an 18 month period. Patients who are
      taking either a third generation AI, tamoxifen or fulvestrant and have a documented evidence
      of progressive disease after achieving a best response of stable disease (for at least 6
      months) or an objective response of CR or PR on the current treatment indicating the
      development of secondary resistance to current therapy will be entered into the study having
      undergone a screening period to continue receiving the same treatment with the addition of
      SFX-01.

      At least 60 patients will be enrolled into one of three arms in a 1:1:1 ratio, i.e. 20
      patients per arm. Enrolment will be based on current treatment.

      Treatment Arm A: All patients will continue to receive their AI and, at the start of the
      study (D1), patients will additionally take SFX-01.

      Treatment Arm B: All patients will continue to receive tamoxifen and, at the start of the
      study (D1), patients will additionally take SFX-01

      Treatment Arm C: All patients will continue to receive fulvestrant 500 mg IM in 28 day Cycles
      and, at the start of the study (D1), patients will additionally take SFX-01.

      Patient participation will include a Screening Phase, a Treatment Phase, and a Follow-up
      Phase of up to 28 weeks post D1 of dosing. The Screening Phase will be up to 28 days prior to
      enrolment. The Treatment Phase will extend from enrolment until the patient is discontinued
      from study treatment. The Follow-up Phase will be a maximum of 28 weeks and extend from the
      time of study entry until 30 days after the patient discontinues trial therapy.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Treatment-Emergent Adverse Events [Safety and Tolerability])
time frame: 28 weeks
description: To determine the safety and tolerability of SFX-01 in combination with AI, tamoxifen and fulvestrant
measure: Clinical benefit rate
time frame: 24 weeks
description: To determine clinical benefit rate (CBR) (CR+PR+SD) at 24 weeks using RECIST v1.1
measure: Objective Response rate
time frame: 24 Weeks
description: To determine objective response rate (ORR) (CR+PR) at 24 weeks using RECIST v1.1
measure: Time To Response
time frame: 24 weeks
description: To determine time to response
measure: Time to Progression
time frame: 24 Weeks
description: To determine time to progression (TTP)
measure: Progression Free Survival
time frame: 24 Weeks
description: To determine progression free survival (PFS) at 24 weeks
measure: Overall Survival
time frame: 24 Weeks
description: To determine overall survival (OS) at 24 weeks
measure: Clinical Benefit
time frame: 24 Weeks
description: To determine clinical benefit by measuring duration of response compared to duration of response to prior ET
measure: Time to next Treatment
time frame: 24 weeks
description: To determine time to next treatment
arm group label: Aromatase Inhibitor
arm group type: Experimental
description: SFX-01 with Aromatase Inhibitor SFX-01 when used in combination with aromatase inhibitors. All patients will continue to receive their AI and, at the start of the study (D1), patients will take SFX-01, which is provided as 300 mg capsules, one to be taken twice daily, 12 hours apart, after food (preferably within 2 hours).
arm group label: Fulvestrant
arm group type: Experimental
description: SFX-01 with Fulvestrant SFX-01 when used in combination with fulvestrant. All patients will continue to receive fulvestrant 500 mg IM in 28 day cycles. As patients will already have been taking this, a repeat loading dose is not necessary. Commencing on study D1 patients will take SFX-01, which is provided as 300 mg capsules, one to be taken twice daily, 12 hours apart, after food (preferably within 2 hours).
arm group label: Tamoxifen
arm group type: Experimental
description: SFX-01 with Tamoxifen SFX-01 when used in combination with tamoxifen All patients will continue to receive tamoxifen and, at the start of the study (D1), patients will take SFX-01, which is provided as 300 mg capsules, one to be taken twice daily, 12 hours apart after food (preferably within 2 hours).
intervention type: Drug
intervention name: SFX-01
description: Stabilised Sulforaphane
arm group label: Aromatase Inhibitor
arm group label: Fulvestrant
arm group label: Tamoxifen
other name: Sulforadex
intervention type: Drug
intervention name: Fulvestrant
description: Fulvestrant
arm group label: Fulvestrant
intervention type: Drug
intervention name: Tamoxifen
description: Tamoxifen
arm group label: Tamoxifen
intervention type: Drug
intervention name: Aromatase Inhibitors
arm group label: Aromatase Inhibitor
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sacha Howell, MD PhD
role: Principal Investigator
affiliation: The Christie NHS Foundation Trust
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Belgium
country: France
country: Spain
country: United Kingdom
country: Czech Republic
responsible party type: Sponsor
mesh term: Breast Neoplasms
mesh term: Tamoxifen
mesh term: Fulvestrant
mesh term: Aromatase Inhibitors
sharing ipd: No