<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/NCT03238703</url>
  </required_header>
  <id_info>
    <org_study_id>9764</org_study_id>
    <secondary_id>NCI-2017-00724</secondary_id>
    <secondary_id>9764</secondary_id>
    <secondary_id>P30CA015704</secondary_id>
    <nct_id>NCT03238703</nct_id>
  </id_info>
  <brief_title>Endocrine Therapy in Treating Patients With HER2 Negative, Low Risk Breast Cancer</brief_title>
  <official_title>An Investigator Initiated Registry of Simple Oral Therapy for Low Risk Breast Cancer (SOLR)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fred Hutchinson Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Fred Hutchinson Cancer Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This pilot clinical trial studies how well endocrine therapy works in treating patients with&#xD;
      HER2 negative, low risk breast cancer. Estrogen can cause the growth of breast cancer cells.&#xD;
      Endocrine therapies such as aromatase inhibitors and selective estrogen receptor modulators&#xD;
      may lessen the amount of estrogen made by the body.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To estimate the conversion rate from a standard low-toxicity approach to&#xD;
      guideline-directed therapy which includes surgery +/- radiation therapy as a result of&#xD;
      progression of disease or patient/provider choice.&#xD;
&#xD;
      II. To examine factors that might differ between those who convert from the low-toxicity&#xD;
      approach to the guideline-directed therapy and those do not convert.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To measure the safety and clinical effectiveness of systemic endocrine therapy used in a&#xD;
      prolonged neoadjuvant fashion.&#xD;
&#xD;
      II. To evaluate the impact of risk-stratified care in Quality-Adjusted Life Years (QALY) and&#xD;
      QALY gains.&#xD;
&#xD;
      III. To estimate the cost savings of indefinitely delaying surgery and radiation in favor of&#xD;
      systemic endocrine therapy alone.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Patients receive exemestane orally (PO) once daily (QD), anastrozole PO QD, letrozole PO QD,&#xD;
      tamoxifen citrate PO QD, or toremifene citrate PO QD at the discretion of the treating&#xD;
      physician. Treatment continues in the absence of disease progression or unacceptable&#xD;
      toxicity.&#xD;
&#xD;
      After completion of study treatment, patients are followed up periodically.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Administrative closure based on sponsor recommendation, prior to subject enrollment&#xD;
  </why_stopped>
  <start_date type="Anticipated">September 1, 2018</start_date>
  <completion_date type="Anticipated">March 14, 2025</completion_date>
  <primary_completion_date type="Anticipated">March 14, 2023</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Conversion from oral endocrine therapy for any reason to guideline-directed therapy</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>Includes clinical or radiographic progression, patient preference, endocrine therapy intolerance or toxicity, or death from any cause. Descriptive statistics will be summarized among all patients and patients within each of the two groups (stay with oral therapy vs conversion due to any causes).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Advanced imaging (if performed on any subset of patients)</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>Will be compared to a concurrent group of patients managed in the conventional manner with upfront surgery +/- radiation therapy followed by systemic endocrine therapy. Descriptive statistics will be summarized among all patients and patients within each of the two groups (stay with oral therapy vs conversion due to any causes).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost-effectiveness and patient-centeredness outcomes defined as financial toxicity and solubility, quality of life (physical, mental, emotional changes) on endocrine therapy, and, access to support services</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>Comparisons will be made to historical benchmarks for similar patients managed in a conventional locoregional manner for early-stage breast cancer. Descriptive statistics will be summarized among all patients and patients within each of the two groups (stay with oral therapy vs conversion due to any causes).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect of age</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>Will be compared to a concurrent group of patients managed in the conventional manner with upfront surgery +/- radiation therapy followed by systemic endocrine therapy. Descriptive statistics will be summarized among all patients and patients within each of the two groups (stay with oral therapy vs conversion due to any causes).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect of comorbidity severity interaction</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>Will be compared to a concurrent group of patients managed in the conventional manner with upfront surgery +/- radiation therapy followed by systemic endocrine therapy. Descriptive statistics will be summarized among all patients and patients within each of the two groups (stay with oral therapy vs conversion due to any causes).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect of type of endocrine therapy type (selective estrogen receptor modifier versus aromatase inhibitor)</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>Will be compared to a concurrent group of patients managed in the conventional manner with upfront surgery +/- radiation therapy followed by systemic endocrine therapy. Descriptive statistics will be summarized among all patients and patients within each of the two groups (stay with oral therapy vs conversion due to any causes).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effects emanating from tertiary care</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>Will be compared to a concurrent group of patients managed in the conventional manner with upfront surgery +/- radiation therapy followed by systemic endocrine therapy. Descriptive statistics will be summarized among all patients and patients within each of the two groups (stay with oral therapy vs conversion due to any causes).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression of disease while on primary endocrine therapy, as measured objectively by routine diagnostic breast imaging (mammography and/or ultrasound)</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>Descriptive statistics will be summarized among all patients and patients within each of the two groups (stay with oral therapy vs conversion due to any causes).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>HER2/Neu Negative</condition>
  <condition>Invasive Breast Carcinoma</condition>
  <condition>Postmenopausal</condition>
  <condition>Stage 0 Breast Cancer</condition>
  <condition>Stage IA Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Treatment (AI, SERM)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive exemestane PO QD, anastrozole PO QD, letrozole PO QD, tamoxifen citrate PO QD, or toremifene citrate PO QD at the discretion of the treating physician. Treatment continues in the absence of disease progression or unacceptable toxicity.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Anastrozole</intervention_name>
    <description>Given PO</description>
    <arm_group_label>Treatment (AI, SERM)</arm_group_label>
    <other_name>Anastrazole</other_name>
    <other_name>Arimidex</other_name>
    <other_name>ICI D1033</other_name>
    <other_name>ICI-D1033</other_name>
    <other_name>ZD-1033</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Exemestane</intervention_name>
    <description>Given PO</description>
    <arm_group_label>Treatment (AI, SERM)</arm_group_label>
    <other_name>Aromasin</other_name>
    <other_name>FCE-24304</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Laboratory Biomarker Analysis</intervention_name>
    <description>Correlative studies</description>
    <arm_group_label>Treatment (AI, SERM)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Letrozole</intervention_name>
    <description>Given PO</description>
    <arm_group_label>Treatment (AI, SERM)</arm_group_label>
    <other_name>CGS 20267</other_name>
    <other_name>Femara</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Quality-of-Life Assessment</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Treatment (AI, SERM)</arm_group_label>
    <other_name>Quality of Life Assessment</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire Administration</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Treatment (AI, SERM)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tamoxifen Citrate</intervention_name>
    <description>Given PO</description>
    <arm_group_label>Treatment (AI, SERM)</arm_group_label>
    <other_name>Apo-Tamox</other_name>
    <other_name>Clonoxifen</other_name>
    <other_name>Dignotamoxi</other_name>
    <other_name>Ebefen</other_name>
    <other_name>Emblon</other_name>
    <other_name>Estroxyn</other_name>
    <other_name>Fentamox</other_name>
    <other_name>Gen-Tamoxifen</other_name>
    <other_name>Genox</other_name>
    <other_name>ICI 46,474</other_name>
    <other_name>ICI-46474</other_name>
    <other_name>Jenoxifen</other_name>
    <other_name>Kessar</other_name>
    <other_name>Ledertam</other_name>
    <other_name>Lesporene</other_name>
    <other_name>Nolgen</other_name>
    <other_name>Noltam</other_name>
    <other_name>Nolvadex</other_name>
    <other_name>Nolvadex-D</other_name>
    <other_name>Nourytam</other_name>
    <other_name>Novo-Tamoxifen</other_name>
    <other_name>Novofen</other_name>
    <other_name>Noxitem</other_name>
    <other_name>Oestrifen</other_name>
    <other_name>Oncotam</other_name>
    <other_name>PMS-Tamoxifen</other_name>
    <other_name>Soltamox</other_name>
    <other_name>TAM</other_name>
    <other_name>Tamax</other_name>
    <other_name>Tamaxin</other_name>
    <other_name>Tamifen</other_name>
    <other_name>Tamizam</other_name>
    <other_name>Tamofen</other_name>
    <other_name>Tamoxasta</other_name>
    <other_name>Tamoxifeni Citras</other_name>
    <other_name>Zemide</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Toremifene Citrate</intervention_name>
    <description>Given PO</description>
    <arm_group_label>Treatment (AI, SERM)</arm_group_label>
    <other_name>Acapodene</other_name>
    <other_name>Fareston</other_name>
    <other_name>FC-1157a</other_name>
    <other_name>GTx-006</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Able to provide written informed consent&#xD;
&#xD;
          -  A diagnosis of invasive breast cancer, with or without an in situ component, that is:&#xD;
&#xD;
               -  Originally identified by screening mammography&#xD;
&#xD;
               -  Characterized by standard diagnostic mammography +/- breast ultrasound&#xD;
&#xD;
               -  Clinically node negative&#xD;
&#xD;
               -  Confirmed by breast magnetic resonance imaging (MRI) in a facility that maintains&#xD;
                  active American College of Radiology (ACR) accreditation to be of low clinical&#xD;
                  stage (=&lt; 2 cm, node negative, unifocal invasive)&#xD;
&#xD;
               -  Estrogen receptor (ER) and progesterone receptor (PR) Allred scored, each &gt; 5/8&#xD;
&#xD;
               -  Her2 negative using American Society of Clinical Oncology (ASCO)-College of&#xD;
                  American Pathologists (CAP) guidelines&#xD;
&#xD;
               -  ki-67 proliferation scored, &lt; 20%&#xD;
&#xD;
               -  Clinical Nottingham grade 1 or 2&#xD;
&#xD;
               -  Scored on the MammaPrint 70-gene breast cancer recurrence assay as low risk&#xD;
&#xD;
          -  Prior to the discovery of the breast cancer, clinically post-menopausal as defined as:&#xD;
             i) one or more years from last menses; or ii) history of oophorectomy; or iii)&#xD;
             follicle stimulating hormone (FSH) test result in the post-menopause reference range&#xD;
&#xD;
          -  Willing to accept oral endocrine therapy with a third generation aromatase inhibitor&#xD;
             (AI) or selective estrogen receptor modifier (SERM)&#xD;
&#xD;
          -  Willing to undergo routine surveillance with breast ultrasound and/or mammography&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known contraindication to aromatase inhibitor or SERM therapy&#xD;
&#xD;
          -  Pregnant at time of or within prior year of diagnosis&#xD;
&#xD;
          -  Clinically detected or palpable disease prior to biopsy in either breast or&#xD;
             ipsilateral axilla&#xD;
&#xD;
          -  Prior history of invasive breast cancer or ductal breast carcinoma in situ (DCIS)&#xD;
&#xD;
          -  Prior use of aromatase inhibitor therapy apart from assisted reproduction&#xD;
&#xD;
          -  Prior use of SERM&#xD;
&#xD;
          -  Unmanaged/uncontrolled mental health disorder&#xD;
&#xD;
          -  Life expectancy &lt; 6 months (m) for any cause&#xD;
&#xD;
          -  Biopsy confirmed multifocal, multicentric, or contralateral disease that is invasive&#xD;
             or non-invasive&#xD;
&#xD;
          -  DCIS with focal invasion&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Vijayakrishna Gadi</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fred Hutch/University of Washington Cancer Consortium</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fred Hutch/University of Washington Cancer Consortium</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>July 31, 2017</study_first_submitted>
  <study_first_submitted_qc>July 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2017</study_first_posted>
  <last_update_submitted>December 26, 2018</last_update_submitted>
  <last_update_submitted_qc>December 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 27, 2018</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>
    <mesh_term>Breast Carcinoma In Situ</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tamoxifen</mesh_term>
    <mesh_term>Toremifene</mesh_term>
    <mesh_term>Letrozole</mesh_term>
    <mesh_term>Anastrozole</mesh_term>
    <mesh_term>Exemestane</mesh_term>
    <mesh_term>Citric Acid</mesh_term>
    <mesh_term>Sodium Citrate</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/NCT03238703
org study id: 9764
secondary id: NCI-2017-00724
secondary id: 9764
secondary id: P30CA015704
nct id: NCT03238703
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This pilot clinical trial studies how well endocrine therapy works in treating patients with
      HER2 negative, low risk breast cancer. Estrogen can cause the growth of breast cancer cells.
      Endocrine therapies such as aromatase inhibitors and selective estrogen receptor modulators
      may lessen the amount of estrogen made by the body.
PRIMARY OBJECTIVES:

      I. To estimate the conversion rate from a standard low-toxicity approach to
      guideline-directed therapy which includes surgery +/- radiation therapy as a result of
      progression of disease or patient/provider choice.

      II. To examine factors that might differ between those who convert from the low-toxicity
      approach to the guideline-directed therapy and those do not convert.

      SECONDARY OBJECTIVES:

      I. To measure the safety and clinical effectiveness of systemic endocrine therapy used in a
      prolonged neoadjuvant fashion.

      II. To evaluate the impact of risk-stratified care in Quality-Adjusted Life Years (QALY) and
      QALY gains.

      III. To estimate the cost savings of indefinitely delaying surgery and radiation in favor of
      systemic endocrine therapy alone.

      OUTLINE:

      Patients receive exemestane orally (PO) once daily (QD), anastrozole PO QD, letrozole PO QD,
      tamoxifen citrate PO QD, or toremifene citrate PO QD at the discretion of the treating
      physician. Treatment continues in the absence of disease progression or unacceptable
      toxicity.

      After completion of study treatment, patients are followed up periodically.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Conversion from oral endocrine therapy for any reason to guideline-directed therapy
time frame: Up to 5 years
description: Includes clinical or radiographic progression, patient preference, endocrine therapy intolerance or toxicity, or death from any cause. Descriptive statistics will be summarized among all patients and patients within each of the two groups (stay with oral therapy vs conversion due to any causes).
measure: Advanced imaging (if performed on any subset of patients)
time frame: Up to 5 years
description: Will be compared to a concurrent group of patients managed in the conventional manner with upfront surgery +/- radiation therapy followed by systemic endocrine therapy. Descriptive statistics will be summarized among all patients and patients within each of the two groups (stay with oral therapy vs conversion due to any causes).
measure: Cost-effectiveness and patient-centeredness outcomes defined as financial toxicity and solubility, quality of life (physical, mental, emotional changes) on endocrine therapy, and, access to support services
time frame: Up to 5 years
description: Comparisons will be made to historical benchmarks for similar patients managed in a conventional locoregional manner for early-stage breast cancer. Descriptive statistics will be summarized among all patients and patients within each of the two groups (stay with oral therapy vs conversion due to any causes).
measure: Effect of age
time frame: Up to 5 years
description: Will be compared to a concurrent group of patients managed in the conventional manner with upfront surgery +/- radiation therapy followed by systemic endocrine therapy. Descriptive statistics will be summarized among all patients and patients within each of the two groups (stay with oral therapy vs conversion due to any causes).
measure: Effect of comorbidity severity interaction
time frame: Up to 5 years
description: Will be compared to a concurrent group of patients managed in the conventional manner with upfront surgery +/- radiation therapy followed by systemic endocrine therapy. Descriptive statistics will be summarized among all patients and patients within each of the two groups (stay with oral therapy vs conversion due to any causes).
measure: Effect of type of endocrine therapy type (selective estrogen receptor modifier versus aromatase inhibitor)
time frame: Up to 5 years
description: Will be compared to a concurrent group of patients managed in the conventional manner with upfront surgery +/- radiation therapy followed by systemic endocrine therapy. Descriptive statistics will be summarized among all patients and patients within each of the two groups (stay with oral therapy vs conversion due to any causes).
measure: Effects emanating from tertiary care
time frame: Up to 5 years
description: Will be compared to a concurrent group of patients managed in the conventional manner with upfront surgery +/- radiation therapy followed by systemic endocrine therapy. Descriptive statistics will be summarized among all patients and patients within each of the two groups (stay with oral therapy vs conversion due to any causes).
measure: Progression of disease while on primary endocrine therapy, as measured objectively by routine diagnostic breast imaging (mammography and/or ultrasound)
time frame: Up to 5 years
description: Descriptive statistics will be summarized among all patients and patients within each of the two groups (stay with oral therapy vs conversion due to any causes).
arm group label: Treatment (AI, SERM)
arm group type: Experimental
description: Patients receive exemestane PO QD, anastrozole PO QD, letrozole PO QD, tamoxifen citrate PO QD, or toremifene citrate PO QD at the discretion of the treating physician. Treatment continues in the absence of disease progression or unacceptable toxicity.
intervention type: Drug
intervention name: Anastrozole
description: Given PO
arm group label: Treatment (AI, SERM)
other name: Anastrazole
other name: Arimidex
other name: ICI D1033
other name: ICI-D1033
other name: ZD-1033
intervention type: Drug
intervention name: Exemestane
description: Given PO
arm group label: Treatment (AI, SERM)
other name: Aromasin
other name: FCE-24304
intervention type: Other
intervention name: Laboratory Biomarker Analysis
description: Correlative studies
arm group label: Treatment (AI, SERM)
intervention type: Drug
intervention name: Letrozole
description: Given PO
arm group label: Treatment (AI, SERM)
other name: CGS 20267
other name: Femara
intervention type: Other
intervention name: Quality-of-Life Assessment
description: Ancillary studies
arm group label: Treatment (AI, SERM)
other name: Quality of Life Assessment
intervention type: Other
intervention name: Questionnaire Administration
description: Ancillary studies
arm group label: Treatment (AI, SERM)
intervention type: Drug
intervention name: Tamoxifen Citrate
description: Given PO
arm group label: Treatment (AI, SERM)
other name: Apo-Tamox
other name: Clonoxifen
other name: Dignotamoxi
other name: Ebefen
other name: Emblon
other name: Estroxyn
other name: Fentamox
other name: Gen-Tamoxifen
other name: Genox
other name: ICI 46,474
other name: ICI-46474
other name: Jenoxifen
other name: Kessar
other name: Ledertam
other name: Lesporene
other name: Nolgen
other name: Noltam
other name: Nolvadex
other name: Nolvadex-D
other name: Nourytam
other name: Novo-Tamoxifen
other name: Novofen
other name: Noxitem
other name: Oestrifen
other name: Oncotam
other name: PMS-Tamoxifen
other name: Soltamox
other name: TAM
other name: Tamax
other name: Tamaxin
other name: Tamifen
other name: Tamizam
other name: Tamofen
other name: Tamoxasta
other name: Tamoxifeni Citras
other name: Zemide
intervention type: Drug
intervention name: Toremifene Citrate
description: Given PO
arm group label: Treatment (AI, SERM)
other name: Acapodene
other name: Fareston
other name: FC-1157a
other name: GTx-006
criteria: 
gender: Female
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
last name: Vijayakrishna Gadi
role: Principal Investigator
affiliation: Fred Hutch/University of Washington Cancer Consortium
facility: 
country: United States
responsible party type: Sponsor
mesh term: Breast Neoplasms
mesh term: Breast Carcinoma In Situ
mesh term: Tamoxifen
mesh term: Toremifene
mesh term: Letrozole
mesh term: Anastrozole
mesh term: Exemestane
mesh term: Citric Acid
mesh term: Sodium Citrate
sharing ipd: No