<?xml version="1.0" encoding="UTF-8"?>
<clinical_study rank="418">
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  <required_header>
    <download_date>ClinicalTrials.gov processed this data on November 07, 2013</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>http://clinicaltrials.gov/show/NCT00003095</url>
  </required_header>
  <id_info>
    <org_study_id>CDR0000065813</org_study_id>
    <secondary_id>S9719</secondary_id>
    <secondary_id>U10CA032102</secondary_id>
    <nct_id>NCT00003095</nct_id>
  </id_info>
  <brief_title>S9719 Gene Damage Following Chemotherapy in Women With Stage II or Stage III Breast Cancer</brief_title>
  <official_title>S9719: Clonal Hematopoiesis as a Marker of Genetic Damage Following Adjuvant Chemotherapy for Breast Cancer: Pilot Study to Evaluate Incidence. Ancillary to S9623</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Southwest Oncology Group</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Southwest Oncology Group</source>
  <oversight_info>
    <authority>United States: Federal Government</authority>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      RATIONALE: Drugs used in chemotherapy for breast cancer may damage the genes of cells. This
      may lead to the development of secondary cancers.

      PURPOSE: Pilot study to evaluate the degree of gene damage following chemotherapy in women
      with stage II or stage III breast cancer involving four to nine axillary lymph nodes.
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      OBJECTIVES: I. Estimate the incidence of early genetic damage, defined by the presence of
      clonal hematopoiesis using the human androgen receptor assay (HUMARA), in pretreatment blood
      and bone marrow, apheresis, and two sequential post-treatment specimens from women with
      stage II/III breast cancer enrolled in SWOG-S9623. II. Detect genetic damage following
      dose-intensive adjuvant regimens for breast cancer by screening for the presence of
      defective DNA mismatch repair mechanisms and loss of heterozygosity using microsatellite
      instability assays. III. Estimate the incidence of myeloid lymphoid leukemia gene fusion
      transcripts in cases where either the HUMARA or microsatellite repeat assays are positive
      for clonal hematopoiesis. IV. Determine the frequency of RAS gene mutations (H-, K-, and
      N-RAS) following dose-intensive adjuvant regimens for breast cancer.

      OUTLINE: Prior to beginning treatment on SWOG-9623, blood samples and bone marrow aspirates
      (when available) are collected from each patient. Patients randomized to autologous
      peripheral stem cell transplant have specimens collected again at 3 months (apheresis
      aliquot and blood). At 3 and 12 months after completing chemotherapy, blood samples are
      collected from all patients. Samples are collected again from any patient presenting with a
      second malignancy in the future. DNA is collected from blood or bone marrow samples.
      Clonality at the HUMARA locus is examined. Microsatellite instability is assessed at
      multiple chromosomal loci: 7q31, 5q31, 17p12, 8p22, 11q23, and the BAT loci. If the HUMARA
      or microsatellite repeat assays are positive for clonal hematopoiesis, then specimens are
      examined for myeloid lymphoid leukemia fusion transcripts commonly reported in acute myeloid
      leukemia with 11q23 abnormalities. Specimens are also examined for RAS mutations (H-, K-,
      N-RAS). Patients do not receive the results of the genetic testing and the results do not
      influence the type or duration of treatment.

      PROJECTED ACCRUAL: This study will accrue 100 patients for each arm of SWOG-9623, for a
      total of 200 patients.
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 1997</start_date>
  <completion_date type="Actual">February 2001</completion_date>
  <primary_completion_date type="Actual">February 2001</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Observational</study_type>
  <study_design>Observational Model: Cohort, Time Perspective: Prospective</study_design>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">26</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>bone marrow transplant</arm_group_label>
    <description>bone marrow transplant</description>
  </arm_group>
  <arm_group>
    <arm_group_label>standard chemotherapy</arm_group_label>
    <description>standard chemotherapy</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      tissue and blood
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Must be enrolled in SWOG-9623 at time of registration to this study, but must not have
        started treatment Hormone receptor status: Not specified
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        DISEASE CHARACTERISTICS: Must be enrolled in SWOG-9623 at time of registration to this
        study, but must not have started treatment Hormone receptor status: Not specified

        PATIENT CHARACTERISTICS: Age: Adult Sex: Female Menopausal status: Not specified
        Performance status: See Disease Characteristics Life expectancy: SWOG 0 or 1
        Hematopoietic: See Disease Characteristics Hepatic: See Disease Characteristics Renal: See
        Disease Characteristics

        PRIOR CONCURRENT THERAPY: See Disease Characteristics
      </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>Marilyn L. Slovak, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Beckman Research Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>MBCCOP - University of South Alabama</name>
      <address>
        <city>Mobile</city>
        <state>Alabama</state>
        <zip>36688</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CCOP - Greater Phoenix</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85006-2726</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Veterans Affairs Medical Center - Phoenix (Hayden)</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85012</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arizona Cancer Center</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85724</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Veterans Affairs Medical Center - Tucson</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85723</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Arkansas for Medical Sciences</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Veterans Affairs Medical Center - Little Rock (McClellan)</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Veterans Affairs Medical Center - Long Beach</name>
      <address>
        <city>Long Beach</city>
        <state>California</state>
        <zip>90822</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>USC/Norris Comprehensive Cancer Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033-0800</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beckman Research Institute, City of Hope</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>91010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jonsson Comprehensive Cancer Center, UCLA</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095-1781</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Veterans Affairs Outpatient Clinic - Martinez</name>
      <address>
        <city>Martinez</city>
        <state>California</state>
        <zip>94553</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CCOP - Bay Area Tumor Institute</name>
      <address>
        <city>Oakland</city>
        <state>California</state>
        <zip>94609-3305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chao Family Comprehensive Cancer Center</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92868</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California Davis Medical Center</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CCOP - Santa Rosa Memorial Hospital</name>
      <address>
        <city>Santa Rosa</city>
        <state>California</state>
        <zip>95403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>David Grant Medical Center</name>
      <address>
        <city>Travis Air Force Base</city>
        <state>California</state>
        <zip>94535</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Colorado Cancer Center</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80262</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Veterans Affairs Medical Center - Denver</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80220</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CCOP - Atlanta Regional</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30342-1701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dwight David Eisenhower Army Medical Center</name>
      <address>
        <city>Fort Gordon</city>
        <state>Georgia</state>
        <zip>30905-5650</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Research Center of Hawaii</name>
      <address>
        <city>Honolulu</city>
        <state>Hawaii</state>
        <zip>96813</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CCOP - Central Illinois</name>
      <address>
        <city>Decatur</city>
        <state>Illinois</state>
        <zip>62526</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)</name>
      <address>
        <city>Hines</city>
        <state>Illinois</state>
        <zip>60141</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Loyola University Medical Center</name>
      <address>
        <city>Maywood</city>
        <state>Illinois</state>
        <zip>60153</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Kansas Medical Center</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66160-7357</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CCOP - Wichita</name>
      <address>
        <city>Wichita</city>
        <state>Kansas</state>
        <zip>67214-3882</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Veterans Affairs Medical Center - Wichita</name>
      <address>
        <city>Wichita</city>
        <state>Kansas</state>
        <zip>67218</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Albert B. Chandler Medical Center, University of Kentucky</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40536-0084</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Veterans Affairs Medical Center - Lexington</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40511-1093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MBCCOP - LSU Medical Center</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tulane University School of Medicine</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Veterans Affairs Medical Center - New Orleans</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Louisiana State University Health Sciences Center - Shreveport</name>
      <address>
        <city>Shreveport</city>
        <state>Louisiana</state>
        <zip>71130-3932</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Veterans Affairs Medical Center - Shreveport</name>
      <address>
        <city>Shreveport</city>
        <state>Louisiana</state>
        <zip>71130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boston Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Veterans Affairs Medical Center - Boston (Jamaica Plain)</name>
      <address>
        <city>Jamaica Plain</city>
        <state>Massachusetts</state>
        <zip>02130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Michigan Comprehensive Cancer Center</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109-0752</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Veterans Affairs Medical Center - Ann Arbor</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henry Ford Hospital</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Barbara Ann Karmanos Cancer Institute</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Veterans Affairs Medical Center - Detroit</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48201-1932</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CCOP - Grand Rapids Clinical Oncology Program</name>
      <address>
        <city>Grand Rapids</city>
        <state>Michigan</state>
        <zip>49503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Providence Hospital - Southfield</name>
      <address>
        <city>Southfield</city>
        <state>Michigan</state>
        <zip>48075-9975</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Veterans Affairs Medical Center - Biloxi</name>
      <address>
        <city>Biloxi</city>
        <state>Mississippi</state>
        <zip>39531-2410</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Mississippi Medical Center</name>
      <address>
        <city>Jackson</city>
        <state>Mississippi</state>
        <zip>39216-4505</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Veterans Affairs Medical Center - Jackson</name>
      <address>
        <city>Jackson</city>
        <state>Mississippi</state>
        <zip>39216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Keesler Medical Center - Keesler AFB</name>
      <address>
        <city>Keesler AFB</city>
        <state>Mississippi</state>
        <zip>39534-2576</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Veterans Affairs Medical Center - Kansas City</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64128</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CCOP - Kansas City</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64131</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CCOP - St. Louis-Cape Girardeau</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63141</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Louis University Health Sciences Center</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110-0250</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CCOP - Cancer Research for the Ozarks</name>
      <address>
        <city>Springfield</city>
        <state>Missouri</state>
        <zip>65807</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CCOP - Montana Cancer Consortium</name>
      <address>
        <city>Billings</city>
        <state>Montana</state>
        <zip>59101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MBCCOP - University of New Mexico HSC</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87131</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Veterans Affairs Medical Center - Albuquerque</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87108-5138</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Herbert Irving Comprehensive Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Barrett Cancer Center, The University Hospital</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Veterans Affairs Medical Center - Cincinnati</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45220-2288</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic Taussig Cancer Center</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CCOP - Columbus</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43206</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Veterans Affairs Medical Center - Dayton</name>
      <address>
        <city>Dayton</city>
        <state>Ohio</state>
        <zip>45428</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CCOP - Dayton</name>
      <address>
        <city>Kettering</city>
        <state>Ohio</state>
        <zip>45429</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oklahoma Medical Research Foundation</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Veterans Affairs Medical Center - Oklahoma City</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CCOP - Columbia River Program</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oregon Cancer Center at Oregon Health Sciences University</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97201-3098</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Veterans Affairs Medical Center - Portland</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CCOP - Greenville</name>
      <address>
        <city>Greenville</city>
        <state>South Carolina</state>
        <zip>29615</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CCOP - Upstate Carolina</name>
      <address>
        <city>Spartanburg</city>
        <state>South Carolina</state>
        <zip>29303</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brooke Army Medical Center</name>
      <address>
        <city>Fort Sam Houston</city>
        <state>Texas</state>
        <zip>78234</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas Medical Branch</name>
      <address>
        <city>Galveston</city>
        <state>Texas</state>
        <zip>77555-1329</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Tech University Health Science Center</name>
      <address>
        <city>Lubbock</city>
        <state>Texas</state>
        <zip>79423</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas Health Science Center at San Antonio</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78284-7811</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Veterans Affairs Medical Center - San Antonio (Murphy)</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78284</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CCOP - Scott and White Hospital</name>
      <address>
        <city>Temple</city>
        <state>Texas</state>
        <zip>76508</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Veterans Affairs Medical Center - Temple</name>
      <address>
        <city>Temple</city>
        <state>Texas</state>
        <zip>76504</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Huntsman Cancer Institute</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84132</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Veterans Affairs Medical Center - Salt Lake City</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84148</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CCOP - Virginia Mason Research Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Veterans Affairs Medical Center - Seattle</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Swedish Cancer Institute</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CCOP - Northwest</name>
      <address>
        <city>Tacoma</city>
        <state>Washington</state>
        <zip>98405-0986</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://cancer.gov/clinicaltrials/SWOG-S9719</url>
    <description>Clinical trial summary from the National Cancer Institute's PDQ® database</description>
  </link>
  <verification_date>November 2013</verification_date>
  <lastchanged_date>November 7, 2013</lastchanged_date>
  <firstreceived_date>November 1, 1999</firstreceived_date>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>stage II breast cancer</keyword>
  <keyword>stage III breast cancer</keyword>
  <is_fda_regulated>No</is_fda_regulated>
  <has_expanded_access>No</has_expanded_access>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm  -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                -->
</clinical_study>