<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/NCT03011060</url>
  </required_header>
  <id_info>
    <org_study_id>JLUDBSCRH 001</org_study_id>
    <nct_id>NCT03011060</nct_id>
  </id_info>
  <brief_title>Sequential Neo-adjuvant Chemotherapy Followed by Capecitabine Vs. Conventional Adjuvant Chemotherapy in Breast Cancer</brief_title>
  <acronym>NACVCAC</acronym>
  <official_title>A Prospective Randomized Controlled Trail to Evaluate Efficacy and Safety of Sequential Neo-adjuvant Chemotherapy Plus Surgery Followed by Capecitabine Versus Conventional Postoperative Adjuvant Chemotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The First Hospital of Jilin University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>First Hospital of China Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Second Affiliated Hospital of Harbin Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Qingdao University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>First Affiliated Hospital Xi'an Jiaotong University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Baotou Cancer Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The First Hospital of Jilin University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates whether sequential neo-adjuvant chemotherapy plus surgery followed by&#xD;
      Capecitabine could achieve additional benefits over traditional postoperative chemotherapy.&#xD;
      In the study group, patients that do not achieve pathological complete response(pCR) will&#xD;
      receive sequential neo-adjuvant chemotherapy followed by Capecitabine. In the control group,&#xD;
      patients will be treated with postoperative adjuvant chemotherapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Neo-adjuvant chemotherapy(NAC) is a standard treatment for locally advanced breast&#xD;
      cancer(LABC). By down-staging LABC, NAC is able to make inoperable cases operable as well as&#xD;
      to make breast conserving surgery an option again for some patients.Neo-adjuvant chemotherapy&#xD;
      is more and more widely used in operable breast cancer since it provides critical information&#xD;
      on chemotherapy response. However, only 15% to 20% of the patients can benefit from&#xD;
      Neo-adjuvant chemotherapy and achieve pCR. Although we obtained the information chemotherapy&#xD;
      response for the rest of the patients who received Neo-adjuvant chemotherapy, there are still&#xD;
      controversies on how the information will be used for further treatment. Therefore, it is a&#xD;
      problem that needs resolving how these patients can benefit from the information Neo-adjuvant&#xD;
      chemotherapy provides and whether Neo-adjuvant chemotherapy can replace conventional adjuvant&#xD;
      chemotherapy at all. Our study aims to make Neo-adjuvant chemotherapy benefit more patients.&#xD;
&#xD;
      Registered patients in stage Ⅰ- Ⅲ A breast cancer is randomly split into two groups(study&#xD;
      group and control group).In the study group, patients achieving pCR will be followed up for 5&#xD;
      years while patients that do not achieve pCR after neo-adjuvant chemotherapy will be treated&#xD;
      with Capecitabine for 8 cycles after surgery. On the other hand, patients in the control&#xD;
      group will accept surgeries and conventional adjuvant chemotherapies. Follow-up study will&#xD;
      last 5 years. DFS and OS will be compared between the two groups.&#xD;
&#xD;
      This study provides an important basis and methods for the further treatment of patients&#xD;
      after neo-adjuvant chemotherapy. It discusses whether neo-adjuvant chemotherapy could replace&#xD;
      conventional adjuvant chemotherapy and become a new standard for breast cancer treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">February 2025</completion_date>
  <primary_completion_date type="Anticipated">December 2024</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Disease-free survival(DFS)</measure>
    <time_frame>5 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival(OS)</measure>
    <time_frame>5 years</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">1588</enrollment>
  <condition>Breast Neoplasm Female</condition>
  <arm_group>
    <arm_group_label>NAC not achieving pCR</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in the study group will accept neo-adjuvant chemotherapy. Among these patients, those who do not achieve pCR after neo-adjuvant chemotherapy will be treated with Capecitabine after surgery. And then they will be followed up for 5 years.&#xD;
Capecitabine 1000mg/m2 tablets twice a day for 8 cycles.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NAC achieving pCR</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in the study group will accept neo-adjuvant chemotherapy. In these patients, those who reach to pCR after neo-adjuvant chemotherapy will be followed up for 5 years after surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Adjuvant Chemotherapy</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients in the control group will accept surgeries and corresponding adjuvant chemotherapy.They will be followed up for 5 years after adjuvant chemotherapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Neo-adjuvant Chemotherapy</intervention_name>
    <description>A preoperative chemotherapy based on anthracyclines and taxanes.</description>
    <arm_group_label>NAC achieving pCR</arm_group_label>
    <arm_group_label>NAC not achieving pCR</arm_group_label>
    <other_name>Preoperative Chemotherapy</other_name>
    <other_name>Primary Chemotherapy</other_name>
    <other_name>Induction Chemotherapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Capecitabine</intervention_name>
    <description>Capecitabine 1000mg/m2 tablets twice a day for 8 cycles.</description>
    <arm_group_label>NAC not achieving pCR</arm_group_label>
    <other_name>Xeloda</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Pathologically confirmed unilateral invasive carcinoma (all pathological types);&#xD;
&#xD;
          2. No gross or microscopic residual tumor after resection;&#xD;
&#xD;
          3. Clinical stage Ⅰ-stage Ⅲ A, no absolute surgical contraindications;&#xD;
&#xD;
          4. Eastern Cooperative Oncology Group(ECOG) score ≤1;&#xD;
&#xD;
          5. Accepting adjuvant chemotherapy within 15 days after surgery;&#xD;
&#xD;
          6. No peripheral neuropathy;&#xD;
&#xD;
          7. Normal bone marrow and organ functions:&#xD;
&#xD;
               1. Bone marrow function: ANC≥1500/mm3，PLT≥100000/mm3，HGB≥8g/dl&#xD;
&#xD;
               2. Renal function: serum creatinine≤1.5 times the upper limit of normal(ULN), Liver&#xD;
                  function: total bilirubin ≤1.5 times the upper limit of normal，AST≤2.5 times the&#xD;
                  upper limit of normal，alanine aminotransferase(ALT)≤2.5 times the upper limit of&#xD;
                  normal&#xD;
&#xD;
               3. Cardiac function:LVEF≥50%&#xD;
&#xD;
          8. Signed informed consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with the history of oral fluorouracil chemotherapy or Chinese medicine&#xD;
             treatment;&#xD;
&#xD;
          2. Patients with organ dysfunction:&#xD;
&#xD;
               1. Renal function: serum creatinine&gt;1.5 times the upper limit of normal&#xD;
&#xD;
               2. Liver function: total bilirubin&gt;1.5 times the upper limit of normal，AST&gt;1.5 times&#xD;
                  the upper limit of normal, alanine aminotransferase(ALT)&gt;1.5 times the upper&#xD;
                  limit of normal or alkaline phosphatase (ALP) &gt;2.5 times the upper limit of&#xD;
                  normal&#xD;
&#xD;
               3. Cardiac function：LVEF&lt;50%;&#xD;
&#xD;
          3. Human epidermal growth factor receptor-2(HER-2) positive patients who cannot receive&#xD;
             Herceptin treatment with a left ventricular ejection fraction(LVEF) less than 55%;&#xD;
&#xD;
          4. Patients allergic to docetaxel, capecitabine, epirubicin and cyclophosphamide;&#xD;
&#xD;
          5. Patients with severe systemic disease and/or uncontrollable infections;&#xD;
&#xD;
          6. Patients with previous malignancies, including contralateral breast cancer;&#xD;
&#xD;
          7. Patients with severe cardiovascular and cerebrovascular disease(i.e. Unstable angina,&#xD;
             chronic cardiac failure, uncontrollable high blood pressure of &gt;150/90 mmhg,&#xD;
             myocardial infarction and cerebrovascular accident) history within 6 months before&#xD;
             randomization;&#xD;
&#xD;
          8. Pregnant or lactating women.&#xD;
&#xD;
          9. Patients who have cognitive or psychological impairment as well as cannot understand&#xD;
             the test program or stand side effects, which will result in a suspension of the trial&#xD;
             program and follow-up;&#xD;
&#xD;
         10. Patients without personal freedom or independent civil capacity.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Fan Zhimin, Professor</last_name>
    <role>Study Chair</role>
    <affiliation>The First Hospital of Jilin University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Fan Zhimin, Professor</last_name>
    <phone>+8613756661286</phone>
    <email>fanzhimn@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Han Bing, Professor</last_name>
    <phone>+8613504316519</phone>
    <email>han_bing@jlu.edu.cn</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>the First Hospital of Jilin University</name>
      <address>
        <city>Changchun</city>
        <state>Jilin</state>
        <zip>130000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Fan Zhimin, Professor</last_name>
      <phone>+86 13756661286</phone>
      <email>fanzhimn@163.com</email>
    </contact>
    <contact_backup>
      <last_name>Han Bing, Professor</last_name>
      <phone>+86 13504316519</phone>
      <email>han_bing@jlu.edu.cn</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <results_reference>
    <citation>Fisher B, Brown A, Mamounas E, Wieand S, Robidoux A, Margolese RG, Cruz AB Jr, Fisher ER, Wickerham DL, Wolmark N, DeCillis A, Hoehn JL, Lees AW, Dimitrov NV. Effect of preoperative chemotherapy on local-regional disease in women with operable breast cancer: findings from National Surgical Adjuvant Breast and Bowel Project B-18. J Clin Oncol. 1997 Jul;15(7):2483-93. doi: 10.1200/JCO.1997.15.7.2483.</citation>
    <PMID>9215816</PMID>
  </results_reference>
  <results_reference>
    <citation>Bear HD, Anderson S, Smith RE, Geyer CE Jr, Mamounas EP, Fisher B, Brown AM, Robidoux A, Margolese R, Kahlenberg MS, Paik S, Soran A, Wickerham DL, Wolmark N. Sequential preoperative or postoperative docetaxel added to preoperative doxorubicin plus cyclophosphamide for operable breast cancer:National Surgical Adjuvant Breast and Bowel Project Protocol B-27. J Clin Oncol. 2006 May 1;24(13):2019-27. doi: 10.1200/JCO.2005.04.1665. Epub 2006 Apr 10.</citation>
    <PMID>16606972</PMID>
  </results_reference>
  <results_reference>
    <citation>Specht J, Gralow JR. Neoadjuvant chemotherapy for locally advanced breast cancer. Semin Radiat Oncol. 2009 Oct;19(4):222-8. doi: 10.1016/j.semradonc.2009.05.001.</citation>
    <PMID>19732686</PMID>
  </results_reference>
  <results_reference>
    <citation>Mathew J, Asgeirsson KS, Cheung KL, Chan S, Dahda A, Robertson JF. Neoadjuvant chemotherapy for locally advanced breast cancer: a review of the literature and future directions. Eur J Surg Oncol. 2009 Feb;35(2):113-22. doi: 10.1016/j.ejso.2008.03.015. Epub 2008 May 23.</citation>
    <PMID>18502088</PMID>
  </results_reference>
  <results_reference>
    <citation>Mieog JS, van de Velde CJ. Neoadjuvant chemotherapy for early breast cancer. Expert Opin Pharmacother. 2009 Jun;10(9):1423-34. doi: 10.1517/14656560903002105.</citation>
    <PMID>19505212</PMID>
  </results_reference>
  <results_reference>
    <citation>Alliot C. In vivo chemosensitivity-adapted preoperative chemotherapy in patients with early-stage breast cancer. Ann Oncol. 2005 Sep;16(9):1559-60; author reply 1560-1. doi: 10.1093/annonc/mdi287. Epub 2005 Aug 3. No abstract available.</citation>
    <PMID>16079161</PMID>
  </results_reference>
  <results_reference>
    <citation>Joensuu H, Kellokumpu-Lehtinen PL, Huovinen R, Jukkola-Vuorinen A, Tanner M, Asola R, Kokko R, Ahlgren J, Auvinen P, Hemminki A, Paija O, Helle L, Nuortio L, Villman K, Nilsson G, Lahtela SL, Lehtio K, Pajunen M, Poikonen P, Nyandoto P, Kataja V, Bono P, Leinonen M, Lindman H; FinXX Study Investigators. Adjuvant capecitabine in combination with docetaxel and cyclophosphamide plus epirubicin for breast cancer: an open-label, randomised controlled trial. Lancet Oncol. 2009 Dec;10(12):1145-51. doi: 10.1016/S1470-2045(09)70307-9. Epub 2009 Nov 10.</citation>
    <PMID>19906561</PMID>
  </results_reference>
  <results_reference>
    <citation>M Toi, S-J Lee.Abstract S1-07: A phase III trial of adjuvant capecitabine in breast cancer patients with HER2-negative pathologic residual invasive disease after neoadjuvant chemotherapy (CREATE-X, JBCRG-04). American Association for Cancer Research 76(4 Supplement):S1-07,2016</citation>
  </results_reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 3, 2017</study_first_submitted>
  <study_first_submitted_qc>January 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 5, 2017</study_first_posted>
  <last_update_submitted>January 8, 2017</last_update_submitted>
  <last_update_submitted_qc>January 8, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 10, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>neo-adjuvant chemotherapy</keyword>
  <keyword>pathological complete response</keyword>
  <keyword>Neoadjuvant Therapy</keyword>
  <keyword>Capecitabine</keyword>
  <keyword>Chemotherapy, Adjuvant</keyword>
  <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>Capecitabine</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/NCT03011060
org study id: JLUDBSCRH 001
nct id: NCT03011060
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
This study evaluates whether sequential neo-adjuvant chemotherapy plus surgery followed by
      Capecitabine could achieve additional benefits over traditional postoperative chemotherapy.
      In the study group, patients that do not achieve pathological complete response(pCR) will
      receive sequential neo-adjuvant chemotherapy followed by Capecitabine. In the control group,
      patients will be treated with postoperative adjuvant chemotherapy.
Neo-adjuvant chemotherapy(NAC) is a standard treatment for locally advanced breast
      cancer(LABC). By down-staging LABC, NAC is able to make inoperable cases operable as well as
      to make breast conserving surgery an option again for some patients.Neo-adjuvant chemotherapy
      is more and more widely used in operable breast cancer since it provides critical information
      on chemotherapy response. However, only 15% to 20% of the patients can benefit from
      Neo-adjuvant chemotherapy and achieve pCR. Although we obtained the information chemotherapy
      response for the rest of the patients who received Neo-adjuvant chemotherapy, there are still
      controversies on how the information will be used for further treatment. Therefore, it is a
      problem that needs resolving how these patients can benefit from the information Neo-adjuvant
      chemotherapy provides and whether Neo-adjuvant chemotherapy can replace conventional adjuvant
      chemotherapy at all. Our study aims to make Neo-adjuvant chemotherapy benefit more patients.

      Registered patients in stage Ⅰ- Ⅲ A breast cancer is randomly split into two groups(study
      group and control group).In the study group, patients achieving pCR will be followed up for 5
      years while patients that do not achieve pCR after neo-adjuvant chemotherapy will be treated
      with Capecitabine for 8 cycles after surgery. On the other hand, patients in the control
      group will accept surgeries and conventional adjuvant chemotherapies. Follow-up study will
      last 5 years. DFS and OS will be compared between the two groups.

      This study provides an important basis and methods for the further treatment of patients
      after neo-adjuvant chemotherapy. It discusses whether neo-adjuvant chemotherapy could replace
      conventional adjuvant chemotherapy and become a new standard for breast cancer treatment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Disease-free survival(DFS)
time frame: 5 years
measure: Overall survival(OS)
time frame: 5 years
arm group label: NAC not achieving pCR
arm group type: Experimental
description: Patients in the study group will accept neo-adjuvant chemotherapy. Among these patients, those who do not achieve pCR after neo-adjuvant chemotherapy will be treated with Capecitabine after surgery. And then they will be followed up for 5 years.
Capecitabine 1000mg/m2 tablets twice a day for 8 cycles.
arm group label: NAC achieving pCR
arm group type: Experimental
description: Patients in the study group will accept neo-adjuvant chemotherapy. In these patients, those who reach to pCR after neo-adjuvant chemotherapy will be followed up for 5 years after surgery.
arm group label: Adjuvant Chemotherapy
arm group type: No Intervention
description: Patients in the control group will accept surgeries and corresponding adjuvant chemotherapy.They will be followed up for 5 years after adjuvant chemotherapy.
intervention type: Procedure
intervention name: Neo-adjuvant Chemotherapy
description: A preoperative chemotherapy based on anthracyclines and taxanes.
arm group label: NAC achieving pCR
arm group label: NAC not achieving pCR
other name: Preoperative Chemotherapy
other name: Primary Chemotherapy
other name: Induction Chemotherapy
intervention type: Drug
intervention name: Capecitabine
description: Capecitabine 1000mg/m2 tablets twice a day for 8 cycles.
arm group label: NAC not achieving pCR
other name: Xeloda
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Fan Zhimin, Professor
role: Study Chair
affiliation: The First Hospital of Jilin University
last name: Fan Zhimin, Professor
phone: +8613756661286
email: fanzhimn@163.com
last name: Han Bing, Professor
phone: +8613504316519
email: han_bing@jlu.edu.cn
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
citation: Fisher B, Brown A, Mamounas E, Wieand S, Robidoux A, Margolese RG, Cruz AB Jr, Fisher ER, Wickerham DL, Wolmark N, DeCillis A, Hoehn JL, Lees AW, Dimitrov NV. Effect of preoperative chemotherapy on local-regional disease in women with operable breast cancer: findings from National Surgical Adjuvant Breast and Bowel Project B-18. J Clin Oncol. 1997 Jul;15(7):2483-93. doi: 10.1200/JCO.1997.15.7.2483.
PMID: 9215816
citation: Bear HD, Anderson S, Smith RE, Geyer CE Jr, Mamounas EP, Fisher B, Brown AM, Robidoux A, Margolese R, Kahlenberg MS, Paik S, Soran A, Wickerham DL, Wolmark N. Sequential preoperative or postoperative docetaxel added to preoperative doxorubicin plus cyclophosphamide for operable breast cancer:National Surgical Adjuvant Breast and Bowel Project Protocol B-27. J Clin Oncol. 2006 May 1;24(13):2019-27. doi: 10.1200/JCO.2005.04.1665. Epub 2006 Apr 10.
PMID: 16606972
citation: Specht J, Gralow JR. Neoadjuvant chemotherapy for locally advanced breast cancer. Semin Radiat Oncol. 2009 Oct;19(4):222-8. doi: 10.1016/j.semradonc.2009.05.001.
PMID: 19732686
citation: Mathew J, Asgeirsson KS, Cheung KL, Chan S, Dahda A, Robertson JF. Neoadjuvant chemotherapy for locally advanced breast cancer: a review of the literature and future directions. Eur J Surg Oncol. 2009 Feb;35(2):113-22. doi: 10.1016/j.ejso.2008.03.015. Epub 2008 May 23.
PMID: 18502088
citation: Mieog JS, van de Velde CJ. Neoadjuvant chemotherapy for early breast cancer. Expert Opin Pharmacother. 2009 Jun;10(9):1423-34. doi: 10.1517/14656560903002105.
PMID: 19505212
citation: Alliot C. In vivo chemosensitivity-adapted preoperative chemotherapy in patients with early-stage breast cancer. Ann Oncol. 2005 Sep;16(9):1559-60; author reply 1560-1. doi: 10.1093/annonc/mdi287. Epub 2005 Aug 3. No abstract available.
PMID: 16079161
citation: Joensuu H, Kellokumpu-Lehtinen PL, Huovinen R, Jukkola-Vuorinen A, Tanner M, Asola R, Kokko R, Ahlgren J, Auvinen P, Hemminki A, Paija O, Helle L, Nuortio L, Villman K, Nilsson G, Lahtela SL, Lehtio K, Pajunen M, Poikonen P, Nyandoto P, Kataja V, Bono P, Leinonen M, Lindman H; FinXX Study Investigators. Adjuvant capecitabine in combination with docetaxel and cyclophosphamide plus epirubicin for breast cancer: an open-label, randomised controlled trial. Lancet Oncol. 2009 Dec;10(12):1145-51. doi: 10.1016/S1470-2045(09)70307-9. Epub 2009 Nov 10.
PMID: 19906561
citation: M Toi, S-J Lee.Abstract S1-07: A phase III trial of adjuvant capecitabine in breast cancer patients with HER2-negative pathologic residual invasive disease after neoadjuvant chemotherapy (CREATE-X, JBCRG-04). American Association for Cancer Research 76(4 Supplement):S1-07,2016
responsible party type: Sponsor
mesh term: Breast Neoplasms
mesh term: Capecitabine
sharing ipd: No