xml: <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/NCT06042569</url>
    </required_header>
    <id_info>
      <org_study_id>21374</org_study_id>
      <secondary_id>NCI-2023-06506</secondary_id>
      <secondary_id>21374</secondary_id>
      <secondary_id>P30CA033572</secondary_id>
      <nct_id>NCT06042569</nct_id>
    </id_info>
    <brief_title>Dose-Reduced Docetaxel With Cyclophosphamide for the Treatment of Vulnerable Older Women With Stage I-III HER2 Negative Breast Cancer, the DOROTHY Trial</brief_title>
    <official_title>Dose Reduction of Docetaxel-Based Chemotherapy in Vulnerable Older Women With Early-Stage Breast Cancer (DOROTHY)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>City of Hope Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Cancer Institute (NCI)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>City of Hope Medical Center</source>
    <oversight_info>
      <has_dmc>Yes</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 phase II trial tests how well dose-reduced docetaxel combined with cyclophosphamide&#xD;
        works in treating older women with early stage (stage I-III) HER2 negative breast cancer&#xD;
        vulnerable to toxicity. Chemotherapy drugs, such as docetaxel and cyclophosphamide, work in&#xD;
        different ways to stop the growth of tumor cells, either by killing the cells, by stopping&#xD;
        them from dividing, or by stopping them from spreading. Docetaxel and cyclophosphamide are&#xD;
        commonly used, but is not well tolerated at the standard dose and can affect the way older&#xD;
        patients feel physically and emotionally. Giving dose-reduced docetaxel combined with&#xD;
        cyclophosphamide may be an effective treatment option and improve quality of life in&#xD;
        vulnerable older women with stage I-III HER2 negative breast cancer.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        PRIMARY OBJECTIVE:&#xD;
  &#xD;
        I. Compare the relative dose intensity (RDI) of reduced- versus (vs.) standard-dose docetaxel&#xD;
        dosing strategies.&#xD;
  &#xD;
        SECONDARY OBJECTIVE:&#xD;
  &#xD;
        I. Compare treatment tolerability of reduced- vs. standard-dose docetaxel dosing strategies.&#xD;
  &#xD;
        OUTLINE: Patients are randomized to 1 of 2 arms.&#xD;
  &#xD;
        ARM I: Patients receive dose-reduced docetaxel intravenously (IV) over 60 minutes and&#xD;
        cyclophosphamide IV over 30 minutes on day 1 of each cycle. Treatment repeats every 21 days&#xD;
        for 4 cycles in the absence of disease progression or unacceptable toxicity.&#xD;
  &#xD;
        ARM II: Patients receive standard dose docetaxel IV over 60 minutes and cyclophosphamide IV&#xD;
        over 30 minutes on day 1 of each cycle. Treatment repeats every 21 days for 4 cycles in the&#xD;
        absence of disease progression or unacceptable toxicity.&#xD;
  &#xD;
        After completion of study treatment, patients are followed up at 30 days then at least twice&#xD;
        yearly for 2 years.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 14, 2023</start_date>
    <completion_date type="Anticipated">August 6, 2026</completion_date>
    <primary_completion_date type="Anticipated">August 6, 2026</primary_completion_date>
    <phase>Phase 2</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Investigator)</masking>
      <masking_description>Randomization module also conceals allocation from other study personnel except the biostatistician and the designated study coordinator by limiting their user's right.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Relative dose intensity (RDI)</measure>
      <time_frame>At completion of 4 cycles, up to 12 weeks (each cycle is every three weeks)</time_frame>
      <description>RDI is defined as the ratio of actual dose intensity received to the standard dose intensity, ranging from 0 to 100%. The RDI between the two arms will be compared using T-test, RDI difference and 90% confidence interval. A one-sided p-value &lt; 0.05 will be considered statistically significant.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Treatment success</measure>
      <time_frame>At completion of 4 cycles, up to 12 weeks (Each cycle is three weeks)</time_frame>
      <description>Treatment success is defined as the proportion of patients who receive all 4 planned cycles of chemotherapy without unacceptable toxicity (grade 3-4), hospitalization/death at the end of treatment, and without decline in physical function status. Proportion of treatment success between the 2 arms will be compared using Chi-square test. A one-sided p-value of &lt; 0.05 will be considered statistically significant.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient-reported symptomatic toxicities</measure>
      <time_frame>At each chemotherapy cycle for 4 cycles, end of treatment and at 3, 6, 12 and 24 months after treatment ends)(Each cycle is three weeks).</time_frame>
      <description>Toxicities will be described using the National Cancer Institute (NCI) Patient Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE). Patient reported outcomes will evaluate how well symptoms reported correlate/agree with clinician reported adverse events.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Differences in PRO-CTCAE and clinician-reported toxicities</measure>
      <time_frame>At each chemotherapy cycle for 4 cycles and at 3, 6, 12, and 24 months after treatment ends (Each cycle is three weeks).</time_frame>
      <description>Treatment related toxicities grade 3 or higher experienced by patients between the 2 arms will be described using NCI-CTCAE version (v) 5.0. Chi-square or Fisher exact test will be used to explore the difference in terms of rate of PRO-CTCAE and clinician reported CTCAE between the 2 arms at the end of chemotherapy. Agreement proportions between PRO-CTCAE and clinician reported CTCAE will be explored and calculated for the 2 arms combined.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient satisfaction</measure>
      <time_frame>Up to 3 months after treatment ends</time_frame>
      <description>Patient-reported satisfaction will be measured using the Was It Worth It questionnaire. Data will be scored and summarized according to their scoring manual. Chi-square or Fisher exact test will be used to compare the proportion of patients who consider it worthwhile to undergo treatment, the proportion of patients who would undergo the treatment again, and the proportionof patients who would recommend the treatment to others between the 2 arms.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in function and health status</measure>
      <time_frame>At baseline and at 3, 6, 12 and 24 months after treatment ends</time_frame>
      <description>Elements of the Geriatric Assessment (GA) will be used to calculate the deficit accumulation index for each patient on each study arm over time. Trajectories of change in function will be examined. Data will be scored and summarized according to the GA scoring manual.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of adverse events</measure>
      <time_frame>At every 3 weeks up to completion of study treatment</time_frame>
      <description>Toxicity experienced by patients for each arm at each cycle will be described using NCI CTCAE v 5.0. Hematologic and non-hematologic toxicities will be examined by grade, type and offending agent.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Invasive disease-free survival</measure>
      <time_frame>Up to 2 years</time_frame>
      <description>Defined as an occurrence of ipsilateral invasive breast cancer recurrence, regional invasive breast cancer recurrence, distant recurrence, death attributable to any cause, contralateral invasive breast cancer and second non-breast invasive cancer.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Local recurrences</measure>
      <time_frame>Up to 3 years</time_frame>
      <description>Local recurrence will be defined as the number of in-breast, chest wall after mastectomy and axillary recurrences.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Distant recurrences</measure>
      <time_frame>Up to 2 years</time_frame>
      <description>Distant recurrence will be defined as the number of recurrences occurring with or without localized recurrence that have occurred distant to the breast.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall survival</measure>
      <time_frame>From registration to death due to any cause up to 24 months</time_frame>
      <description>Breast cancer-specific survival and cause of death will also be examined.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Progression-free survival</measure>
      <time_frame>From registration to the earliest of progression or death due to any cause up to 24 months</time_frame>
      <description>The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse. In a clinical trial, measuring the progression-free survival is one way to see how well a new treatment works.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">174</enrollment>
    <condition>Anatomic Stage I Breast Cancer AJCC v8</condition>
    <condition>Anatomic Stage II Breast Cancer AJCC v8</condition>
    <condition>Anatomic Stage III Breast Cancer AJCC v8</condition>
    <condition>HER2-Negative Breast Carcinoma</condition>
    <arm_group>
      <arm_group_label>Arm I: (Dose-reduced docetaxel, cyclophosphamide)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients receive dose-reduced docetaxel IV over 60 minutes and cyclophosphamide IV over 30 minutes on day 1 of each cycle. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Arm II: (Standard dose docetaxel, cyclophosphamide)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Patients receive standard dose docetaxel IV over 60 minutes and cyclophosphamide IV over 30 minutes on day 1 of each cycle. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Cyclophosphamide</intervention_name>
      <description>Given IV</description>
      <arm_group_label>Arm I: (Dose-reduced docetaxel, cyclophosphamide)</arm_group_label>
      <arm_group_label>Arm II: (Standard dose docetaxel, cyclophosphamide)</arm_group_label>
      <other_name>(-)-Cyclophosphamide</other_name>
      <other_name>2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate</other_name>
      <other_name>Carloxan</other_name>
      <other_name>Ciclofosfamida</other_name>
      <other_name>Ciclofosfamide</other_name>
      <other_name>Cicloxal</other_name>
      <other_name>Clafen</other_name>
      <other_name>Claphene</other_name>
      <other_name>CP monohydrate</other_name>
      <other_name>CTX</other_name>
      <other_name>CYCLO-cell</other_name>
      <other_name>Cycloblastin</other_name>
      <other_name>Cycloblastine</other_name>
      <other_name>Cyclophospham</other_name>
      <other_name>Cyclophosphamid monohydrate</other_name>
      <other_name>Cyclophosphamide Monohydrate</other_name>
      <other_name>Cyclophosphamidum</other_name>
      <other_name>Cyclophosphan</other_name>
      <other_name>Cyclophosphane</other_name>
      <other_name>Cyclophosphanum</other_name>
      <other_name>Cyclostin</other_name>
      <other_name>Cyclostine</other_name>
      <other_name>Cytophosphan</other_name>
      <other_name>Cytophosphane</other_name>
      <other_name>Cytoxan</other_name>
      <other_name>Fosfaseron</other_name>
      <other_name>Genoxal</other_name>
      <other_name>Genuxal</other_name>
      <other_name>Ledoxina</other_name>
      <other_name>Mitoxan</other_name>
      <other_name>Neosar</other_name>
      <other_name>Revimmune</other_name>
      <other_name>Syklofosfamid</other_name>
      <other_name>WR- 138719</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Docetaxel</intervention_name>
      <description>Given IV</description>
      <arm_group_label>Arm I: (Dose-reduced docetaxel, cyclophosphamide)</arm_group_label>
      <arm_group_label>Arm II: (Standard dose docetaxel, cyclophosphamide)</arm_group_label>
      <other_name>Docecad</other_name>
      <other_name>RP56976</other_name>
      <other_name>Taxotere</other_name>
      <other_name>Taxotere Injection Concentrate</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Medical Chart Review</intervention_name>
      <description>Ancillary studies</description>
      <arm_group_label>Arm I: (Dose-reduced docetaxel, cyclophosphamide)</arm_group_label>
      <arm_group_label>Arm II: (Standard dose docetaxel, cyclophosphamide)</arm_group_label>
      <other_name>Chart Review</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Questionnaire Administration</intervention_name>
      <description>Ancillary studies</description>
      <arm_group_label>Arm I: (Dose-reduced docetaxel, cyclophosphamide)</arm_group_label>
      <arm_group_label>Arm II: (Standard dose docetaxel, cyclophosphamide)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Ability to provided informed consent or a legally authorized representative is able to&#xD;
               consent on behalf of the patient&#xD;
  &#xD;
            -  Willing to answer questionnaires as part of their participation&#xD;
  &#xD;
            -  Age: &gt;= 65 years by the time of study registration&#xD;
  &#xD;
            -  Cancer and Aging Research Group- Breast Cancer (CARG-BC) score &gt;= 6&#xD;
  &#xD;
            -  Histologically or cytologically confirmed breast cancer(s) that is human epidermal&#xD;
               growth factor receptor 2 negative (HER2-negative) per the most recent 2018 American&#xD;
               Society of Clinical Oncology College of American Pathologists (ASCO CAP) guidelines&#xD;
               relapsed/ refractory disease&#xD;
  &#xD;
            -  Estrogen receptor and progesterone receptor immunohistochemistry (IHC) status must be&#xD;
               known; any estrogen receptor (ER)/progesterone receptor (PR) status is eligible&#xD;
  &#xD;
            -  Non-metastatic, invasive breast cancer (scans are not required to document&#xD;
               non-metastatic disease- any staging work-up is up to the treating providers'&#xD;
               discretion)&#xD;
  &#xD;
            -  Recommended to have either standard dose neoadjuvant docetaxel, cyclophosphamide (TC)&#xD;
               chemotherapy or adjuvant TC chemotherapy per their treating provider. Participant may&#xD;
               be on immunotherapy concurrently with the protocol regimen at the discretion of the&#xD;
               treating physician&#xD;
  &#xD;
            -  Any surgery, nodal assessment, radiation, hormonal therapy is left up to the treating&#xD;
               provider but should not occur concurrently with study therapy&#xD;
  &#xD;
            -  Any patient who received pre-operative hormonal therapy and who is then recommended&#xD;
               for neo/adjuvant chemotherapy is eligible, though hormonal therapy should be held&#xD;
               during study treatment administration&#xD;
  &#xD;
            -  For patients with bilateral or multifocal/multicentric breast cancers, the following&#xD;
               criteria must be met to enroll: (1) both cancer are HER2 negative, AND (2) the&#xD;
               provider feels the patient will benefit from TC for at least one of the cancers&#xD;
  &#xD;
            -  Patients who do not speak or read English are eligible as long as adequate interpreter&#xD;
               services are available or the surveys are available in the preferred language (i.e.&#xD;
               the Geriatric Assessment [GA] and Patient Reported Outcomes [PRO] surveys are&#xD;
               available in many languages)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Participants who have already received any chemotherapy for their current breast&#xD;
               cancer&#xD;
  &#xD;
            -  Patients with recurrent and/or metastatic disease will be excluded. Prior diagnoses of&#xD;
               breast cancers (including ductal carcinoma in situ [DCIS]) are allowed, provided that&#xD;
               the treating provider feels that the current cancer most likely represents a new&#xD;
               primary breast cancer and not recurrent disease&#xD;
  &#xD;
            -  History of allergic reactions attributed to compounds of similar chemical or biologic&#xD;
               composition to cyclophosphamide and/or docetaxel&#xD;
  &#xD;
            -  Past treatment with the regimen TC for prior breast cancer&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>65 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Joanne E Mortimer</last_name>
      <role>Principal Investigator</role>
      <affiliation>City of Hope Medical Center</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>City of Hope Medical Center</name>
        <address>
          <city>Duarte</city>
          <state>California</state>
          <zip>91010</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Joanne E. Mortimer</last_name>
        <phone>626-256-4673</phone>
        <email>JMortimer@coh.org</email>
      </contact>
      <investigator>
        <last_name>Joanne E. Mortimer</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 7, 2023</study_first_submitted>
    <study_first_submitted_qc>September 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 15, 2023</last_update_submitted>
    <last_update_submitted_qc>September 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</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>Cyclophosphamide</mesh_term>
      <mesh_term>Docetaxel</mesh_term>
    </intervention_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06042569
  org study id: 21374
  secondary id: NCI-2023-06506
  secondary id: 21374
  secondary id: P30CA033572
  nct id: NCT06042569
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  This phase II trial tests how well dose-reduced docetaxel combined with cyclophosphamide
        works in treating older women with early stage (stage I-III) HER2 negative breast cancer
        vulnerable to toxicity. Chemotherapy drugs, such as docetaxel and cyclophosphamide, work in
        different ways to stop the growth of tumor cells, either by killing the cells, by stopping
        them from dividing, or by stopping them from spreading. Docetaxel and cyclophosphamide are
        commonly used, but is not well tolerated at the standard dose and can affect the way older
        patients feel physically and emotionally. Giving dose-reduced docetaxel combined with
        cyclophosphamide may be an effective treatment option and improve quality of life in
        vulnerable older women with stage I-III HER2 negative breast cancer.
  PRIMARY OBJECTIVE:
  
        I. Compare the relative dose intensity (RDI) of reduced- versus (vs.) standard-dose docetaxel
        dosing strategies.
  
        SECONDARY OBJECTIVE:
  
        I. Compare treatment tolerability of reduced- vs. standard-dose docetaxel dosing strategies.
  
        OUTLINE: Patients are randomized to 1 of 2 arms.
  
        ARM I: Patients receive dose-reduced docetaxel intravenously (IV) over 60 minutes and
        cyclophosphamide IV over 30 minutes on day 1 of each cycle. Treatment repeats every 21 days
        for 4 cycles in the absence of disease progression or unacceptable toxicity.
  
        ARM II: Patients receive standard dose docetaxel IV over 60 minutes and cyclophosphamide IV
        over 30 minutes on day 1 of each cycle. Treatment repeats every 21 days for 4 cycles in the
        absence of disease progression or unacceptable toxicity.
  
        After completion of study treatment, patients are followed up at 30 days then at least twice
        yearly for 2 years.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Investigator)
  masking description: Randomization module also conceals allocation from other study personnel except the biostatistician and the designated study coordinator by limiting their user's right.
  measure: Relative dose intensity (RDI)
  time frame: At completion of 4 cycles, up to 12 weeks (each cycle is every three weeks)
  description: RDI is defined as the ratio of actual dose intensity received to the standard dose intensity, ranging from 0 to 100%. The RDI between the two arms will be compared using T-test, RDI difference and 90% confidence interval. A one-sided p-value < 0.05 will be considered statistically significant.
  measure: Treatment success
  time frame: At completion of 4 cycles, up to 12 weeks (Each cycle is three weeks)
  description: Treatment success is defined as the proportion of patients who receive all 4 planned cycles of chemotherapy without unacceptable toxicity (grade 3-4), hospitalization/death at the end of treatment, and without decline in physical function status. Proportion of treatment success between the 2 arms will be compared using Chi-square test. A one-sided p-value of < 0.05 will be considered statistically significant.
  measure: Patient-reported symptomatic toxicities
  time frame: At each chemotherapy cycle for 4 cycles, end of treatment and at 3, 6, 12 and 24 months after treatment ends)(Each cycle is three weeks).
  description: Toxicities will be described using the National Cancer Institute (NCI) Patient Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE). Patient reported outcomes will evaluate how well symptoms reported correlate/agree with clinician reported adverse events.
  measure: Differences in PRO-CTCAE and clinician-reported toxicities
  time frame: At each chemotherapy cycle for 4 cycles and at 3, 6, 12, and 24 months after treatment ends (Each cycle is three weeks).
  description: Treatment related toxicities grade 3 or higher experienced by patients between the 2 arms will be described using NCI-CTCAE version (v) 5.0. Chi-square or Fisher exact test will be used to explore the difference in terms of rate of PRO-CTCAE and clinician reported CTCAE between the 2 arms at the end of chemotherapy. Agreement proportions between PRO-CTCAE and clinician reported CTCAE will be explored and calculated for the 2 arms combined.
  measure: Patient satisfaction
  time frame: Up to 3 months after treatment ends
  description: Patient-reported satisfaction will be measured using the Was It Worth It questionnaire. Data will be scored and summarized according to their scoring manual. Chi-square or Fisher exact test will be used to compare the proportion of patients who consider it worthwhile to undergo treatment, the proportion of patients who would undergo the treatment again, and the proportionof patients who would recommend the treatment to others between the 2 arms.
  measure: Changes in function and health status
  time frame: At baseline and at 3, 6, 12 and 24 months after treatment ends
  description: Elements of the Geriatric Assessment (GA) will be used to calculate the deficit accumulation index for each patient on each study arm over time. Trajectories of change in function will be examined. Data will be scored and summarized according to the GA scoring manual.
  measure: Incidence of adverse events
  time frame: At every 3 weeks up to completion of study treatment
  description: Toxicity experienced by patients for each arm at each cycle will be described using NCI CTCAE v 5.0. Hematologic and non-hematologic toxicities will be examined by grade, type and offending agent.
  measure: Invasive disease-free survival
  time frame: Up to 2 years
  description: Defined as an occurrence of ipsilateral invasive breast cancer recurrence, regional invasive breast cancer recurrence, distant recurrence, death attributable to any cause, contralateral invasive breast cancer and second non-breast invasive cancer.
  measure: Local recurrences
  time frame: Up to 3 years
  description: Local recurrence will be defined as the number of in-breast, chest wall after mastectomy and axillary recurrences.
  measure: Distant recurrences
  time frame: Up to 2 years
  description: Distant recurrence will be defined as the number of recurrences occurring with or without localized recurrence that have occurred distant to the breast.
  measure: Overall survival
  time frame: From registration to death due to any cause up to 24 months
  description: Breast cancer-specific survival and cause of death will also be examined.
  measure: Progression-free survival
  time frame: From registration to the earliest of progression or death due to any cause up to 24 months
  description: The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse. In a clinical trial, measuring the progression-free survival is one way to see how well a new treatment works.
  arm group label: Arm I: (Dose-reduced docetaxel, cyclophosphamide)
  arm group type: Experimental
  description: Patients receive dose-reduced docetaxel IV over 60 minutes and cyclophosphamide IV over 30 minutes on day 1 of each cycle. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity.
  arm group label: Arm II: (Standard dose docetaxel, cyclophosphamide)
  arm group type: Active Comparator
  description: Patients receive standard dose docetaxel IV over 60 minutes and cyclophosphamide IV over 30 minutes on day 1 of each cycle. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity.
  intervention type: Drug
  intervention name: Cyclophosphamide
  description: Given IV
  arm group label: Arm I: (Dose-reduced docetaxel, cyclophosphamide)
  arm group label: Arm II: (Standard dose docetaxel, cyclophosphamide)
  other name: (-)-Cyclophosphamide
  other name: 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate
  other name: Carloxan
  other name: Ciclofosfamida
  other name: Ciclofosfamide
  other name: Cicloxal
  other name: Clafen
  other name: Claphene
  other name: CP monohydrate
  other name: CTX
  other name: CYCLO-cell
  other name: Cycloblastin
  other name: Cycloblastine
  other name: Cyclophospham
  other name: Cyclophosphamid monohydrate
  other name: Cyclophosphamide Monohydrate
  other name: Cyclophosphamidum
  other name: Cyclophosphan
  other name: Cyclophosphane
  other name: Cyclophosphanum
  other name: Cyclostin
  other name: Cyclostine
  other name: Cytophosphan
  other name: Cytophosphane
  other name: Cytoxan
  other name: Fosfaseron
  other name: Genoxal
  other name: Genuxal
  other name: Ledoxina
  other name: Mitoxan
  other name: Neosar
  other name: Revimmune
  other name: Syklofosfamid
  other name: WR- 138719
  intervention type: Drug
  intervention name: Docetaxel
  description: Given IV
  arm group label: Arm I: (Dose-reduced docetaxel, cyclophosphamide)
  arm group label: Arm II: (Standard dose docetaxel, cyclophosphamide)
  other name: Docecad
  other name: RP56976
  other name: Taxotere
  other name: Taxotere Injection Concentrate
  intervention type: Other
  intervention name: Medical Chart Review
  description: Ancillary studies
  arm group label: Arm I: (Dose-reduced docetaxel, cyclophosphamide)
  arm group label: Arm II: (Standard dose docetaxel, cyclophosphamide)
  other name: Chart Review
  intervention type: Other
  intervention name: Questionnaire Administration
  description: Ancillary studies
  arm group label: Arm I: (Dose-reduced docetaxel, cyclophosphamide)
  arm group label: Arm II: (Standard dose docetaxel, cyclophosphamide)
  criteria: 
  gender: All
  minimum age: 65 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Joanne E Mortimer
  role: Principal Investigator
  affiliation: City of Hope Medical Center
  facility: 
  contact: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Breast Neoplasms
  mesh term: Cyclophosphamide
  mesh term: Docetaxel