<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/NCT02995772</url>
  </required_header>
  <id_info>
    <org_study_id>049/PEP/08/2011</org_study_id>
    <nct_id>NCT02995772</nct_id>
  </id_info>
  <brief_title>Neoadjuvant Hormonal Therapy Compared to Neoadjuvant Chemotherapy in Stage IIIB/C and IV Breast Cancer Patients</brief_title>
  <official_title>Preoperative Neoadjuvant Hormonal Therapy and Neoadjuvant Chemotherapy for Stage IIIB and IV Breast Cancer Patients in Dharmais National Cancer Center Hospital, Indonesia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dharmais National Cancer Center Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Dharmais National Cancer Center Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study compared long term outcome of stage IIIB/C and IV breast cancer patients treated&#xD;
      with neoadjuvant hormonal therapy (NAHT) and those treated with neoadjuvant chemotherapy&#xD;
      (NACT)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study compared long term outcome of stage IIIB/C and IV breast cancer patients treated&#xD;
      with neoadjuvant hormonal therapy (NAHT) and those treated with neoadjuvant chemotherapy&#xD;
      (NACT) between 2011 and 2016.&#xD;
&#xD;
      The primary end points are overall survival (OS) and progression free survival (PFS) with&#xD;
      Kaplan Meier.&#xD;
&#xD;
      This study was approved by Ethical Committee in Dharmais National Cancer Hospital.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2011</start_date>
  <completion_date type="Actual">November 2018</completion_date>
  <primary_completion_date type="Actual">November 2018</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall survival</measure>
    <time_frame>time from the date of pathological diagnosis until death from any cause and until minimum sample sizes are met and an average 3 years</time_frame>
    <description>length of time from the date of pathological diagnosis until death from any cause</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progressive free survival</measure>
    <time_frame>time from after treatment until tumor progression or death from any cause and until minimum sample sizes are met and an average 3 years</time_frame>
    <description>length of time from after treatment until tumor progression or death from any cause</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">122</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Neoadjuvant hormonal therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Neoadjuvant hormonal therapy: Aromatase inhibitors (Arimidex, Femara, Aromasin), Tamoxifen, SOB and AI, SOB and Tamoxifen</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Neoadjuvant chemotherapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Neoadjuvant chemotherapy: FAC 6 cycles</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Aromatase Inhibitors (Arimidex)</intervention_name>
    <description>Comparison of efficacy with chemotherapy</description>
    <arm_group_label>Neoadjuvant hormonal therapy</arm_group_label>
    <other_name>Anastrozole</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tamoxifen</intervention_name>
    <description>Comparison of efficacy with chemotherapy</description>
    <arm_group_label>Neoadjuvant hormonal therapy</arm_group_label>
    <other_name>Nolvadex</other_name>
    <other_name>Soltamox</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>SOB</intervention_name>
    <description>Comparison of efficacy with chemotherapy</description>
    <arm_group_label>Neoadjuvant hormonal therapy</arm_group_label>
    <other_name>Salpingo-oophorectomy Bilateral</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>FAC</intervention_name>
    <description>Comparison of efficacy with hormonal therapy</description>
    <arm_group_label>Neoadjuvant chemotherapy</arm_group_label>
    <other_name>Fluorouracil, Adriamycin, Cytoxan</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Aromatase Inhibitors (Femara)</intervention_name>
    <description>Comparison of efficacy with chemotherapy</description>
    <arm_group_label>Neoadjuvant hormonal therapy</arm_group_label>
    <other_name>Letrozole</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Aromatase Inhibitors (Aromasin)</intervention_name>
    <description>Comparison of efficacy with chemotherapy</description>
    <arm_group_label>Neoadjuvant hormonal therapy</arm_group_label>
    <other_name>Exemestane</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  IIIB/C and IV stage of breast cancer&#xD;
&#xD;
          -  received neoadjuvant hormonal therapy or neoadjuvant chemotherapy&#xD;
&#xD;
          -  had first and second biopsy (surgery) within 6 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  had mastectomy before treatment&#xD;
&#xD;
          -  pregnant&#xD;
&#xD;
          -  disagree to enter the study&#xD;
&#xD;
          -  had been given hormonal therapy or chemotherapy before study&#xD;
&#xD;
          -  had contra-indication of SOB for pre-menopausal patients&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ramadhan Karsono, Doctoral</last_name>
    <role>Study Chair</role>
    <affiliation>Dharmais National Cancer Center Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dharmais National Cancer Center Hospital</name>
      <address>
        <city>Jakarta</city>
        <zip>11420</zip>
        <country>Indonesia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Indonesia</country>
  </location_countries>
  <results_reference>
    <citation>Beatson GT. On the Treatment of Inoperable Cases of Carcinoma of the Mamma: Suggestions for a New Method of Treatment, with Illustrative Cases. Trans Med Chir Soc Edinb. 1896;15:153-179. No abstract available.</citation>
    <PMID>29584099</PMID>
  </results_reference>
  <results_reference>
    <citation>van de Vijver MJ, He YD, van't Veer LJ, Dai H, Hart AA, Voskuil DW, Schreiber GJ, Peterse JL, Roberts C, Marton MJ, Parrish M, Atsma D, Witteveen A, Glas A, Delahaye L, van der Velde T, Bartelink H, Rodenhuis S, Rutgers ET, Friend SH, Bernards R. A gene-expression signature as a predictor of survival in breast cancer. N Engl J Med. 2002 Dec 19;347(25):1999-2009. doi: 10.1056/NEJMoa021967.</citation>
    <PMID>12490681</PMID>
  </results_reference>
  <results_reference>
    <citation>Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: an overview of the randomised trials. Lancet. 2005 May 14-20;365(9472):1687-717. doi: 10.1016/S0140-6736(05)66544-0.</citation>
    <PMID>15894097</PMID>
  </results_reference>
  <results_reference>
    <citation>Cardoso F, van't Veer LJ, Bogaerts J, Slaets L, Viale G, Delaloge S, Pierga JY, Brain E, Causeret S, DeLorenzi M, Glas AM, Golfinopoulos V, Goulioti T, Knox S, Matos E, Meulemans B, Neijenhuis PA, Nitz U, Passalacqua R, Ravdin P, Rubio IT, Saghatchian M, Smilde TJ, Sotiriou C, Stork L, Straehle C, Thomas G, Thompson AM, van der Hoeven JM, Vuylsteke P, Bernards R, Tryfonidis K, Rutgers E, Piccart M; MINDACT Investigators. 70-Gene Signature as an Aid to Treatment Decisions in Early-Stage Breast Cancer. N Engl J Med. 2016 Aug 25;375(8):717-29. doi: 10.1056/NEJMoa1602253.</citation>
    <PMID>27557300</PMID>
  </results_reference>
  <results_reference>
    <citation>Asad J, Jacobson AF, Estabrook A, Smith SR, Boolbol SK, Feldman SM, Osborne MP, Boachie-Adjei K, Twardzik W, Tartter PI. Does oncotype DX recurrence score affect the management of patients with early-stage breast cancer? Am J Surg. 2008 Oct;196(4):527-9. doi: 10.1016/j.amjsurg.2008.06.021.</citation>
    <PMID>18809056</PMID>
  </results_reference>
  <results_reference>
    <citation>Teshome M, Hunt KK. Neoadjuvant therapy in the treatment of breast cancer. Surg Oncol Clin N Am. 2014 Jul;23(3):505-23. doi: 10.1016/j.soc.2014.03.006. Epub 2014 Apr 24.</citation>
    <PMID>24882348</PMID>
  </results_reference>
  <results_reference>
    <citation>Mauriac L, MacGrogan G, Avril A, Durand M, Floquet A, Debled M, Dilhuydy JM, Bonichon F. Neoadjuvant chemotherapy for operable breast carcinoma larger than 3 cm: a unicentre randomized trial with a 124-month median follow-up. Institut Bergonie Bordeaux Groupe Sein (IBBGS). Ann Oncol. 1999 Jan;10(1):47-52. doi: 10.1023/a:1008337009350.</citation>
    <PMID>10076721</PMID>
  </results_reference>
  <results_reference>
    <citation>Chia YH, Ellis MJ, Ma CX. Neoadjuvant endocrine therapy in primary breast cancer: indications and use as a research tool. Br J Cancer. 2010 Sep 7;103(6):759-64. doi: 10.1038/sj.bjc.6605845. Epub 2010 Aug 10.</citation>
    <PMID>20700118</PMID>
  </results_reference>
  <results_reference>
    <citation>Bossuyt V, Provenzano E, Symmans WF, Boughey JC, Coles C, Curigliano G, Dixon JM, Esserman LJ, Fastner G, Kuehn T, Peintinger F, von Minckwitz G, White J, Yang W, Badve S, Denkert C, MacGrogan G, Penault-Llorca F, Viale G, Cameron D; Breast International Group-North American Breast Cancer Group (BIG-NABCG) collaboration. Recommendations for standardized pathological characterization of residual disease for neoadjuvant clinical trials of breast cancer by the BIG-NABCG collaboration. Ann Oncol. 2015 Jul;26(7):1280-91. doi: 10.1093/annonc/mdv161. Epub 2015 May 27.</citation>
    <PMID>26019189</PMID>
  </results_reference>
  <results_reference>
    <citation>Chuang E, Paul C, Flam A, McCarville K, Forst M, Shin S, Vahdat L, Swistel A, Simmons R, Osborne M. Breast cancer subtypes in Asian-Americans differ according to Asian ethnic group. J Immigr Minor Health. 2012 Oct;14(5):754-8. doi: 10.1007/s10903-012-9577-7.</citation>
    <PMID>22286607</PMID>
  </results_reference>
  <results_reference>
    <citation>Hammond ME, Hayes DF, Dowsett M, Allred DC, Hagerty KL, Badve S, Fitzgibbons PL, Francis G, Goldstein NS, Hayes M, Hicks DG, Lester S, Love R, Mangu PB, McShane L, Miller K, Osborne CK, Paik S, Perlmutter J, Rhodes A, Sasano H, Schwartz JN, Sweep FC, Taube S, Torlakovic EE, Valenstein P, Viale G, Visscher D, Wheeler T, Williams RB, Wittliff JL, Wolff AC; American Society of Clinical Oncology; College of American Pathologists. American Society of Clinical Oncology/College of American Pathologists guideline recommendations for immunohistochemical testing of estrogen and progesterone receptors in breast cancer (unabridged version). Arch Pathol Lab Med. 2010 Jul;134(7):e48-72. doi: 10.5858/134.7.e48.</citation>
    <PMID>20586616</PMID>
  </results_reference>
  <results_reference>
    <citation>Marcus DM, Switchenko JM, Prabhu R, O'Regan R, Zelnak A, Fasola C, Mister D, Torres MA. Neoadjuvant Hormonal Therapy is Associated with Comparable Outcomes to Neoadjuvant Chemotherapy in Post-Menopausal Women with Estrogen Receptor-Positive Breast Cancer. Front Oncol. 2013 Dec 27;3:317. doi: 10.3389/fonc.2013.00317. eCollection 2013.</citation>
    <PMID>24409418</PMID>
  </results_reference>
  <results_reference>
    <citation>Semiglazov VF, Semiglazov VV, Dashyan GA, Ziltsova EK, Ivanov VG, Bozhok AA, Melnikova OA, Paltuev RM, Kletzel A, Berstein LM. Phase 2 randomized trial of primary endocrine therapy versus chemotherapy in postmenopausal patients with estrogen receptor-positive breast cancer. Cancer. 2007 Jul 15;110(2):244-54. doi: 10.1002/cncr.22789.</citation>
    <PMID>17538978</PMID>
  </results_reference>
  <results_reference>
    <citation>Preece PE, Wood RA, Mackie CR, Cuschieri A. Tamoxifen as initial sole treatment of localised breast cancer in elderly women: a pilot study. Br Med J (Clin Res Ed). 1982 Mar 20;284(6319):869-70. doi: 10.1136/bmj.284.6319.869-a. No abstract available.</citation>
    <PMID>6802332</PMID>
  </results_reference>
  <results_reference>
    <citation>Rastogi P, Anderson SJ, Bear HD, Geyer CE, Kahlenberg MS, Robidoux A, Margolese RG, Hoehn JL, Vogel VG, Dakhil SR, Tamkus D, King KM, Pajon ER, Wright MJ, Robert J, Paik S, Mamounas EP, Wolmark N. Preoperative chemotherapy: updates of National Surgical Adjuvant Breast and Bowel Project Protocols B-18 and B-27. J Clin Oncol. 2008 Feb 10;26(5):778-85. doi: 10.1200/JCO.2007.15.0235. Erratum In: J Clin Oncol. 2008 Jun 1;26(16):2793.</citation>
    <PMID>18258986</PMID>
  </results_reference>
  <results_reference>
    <citation>Schneeweiss A, Chia S, Hickish T, Harvey V, Eniu A, Hegg R, Tausch C, Seo JH, Tsai YF, Ratnayake J, McNally V, Ross G, Cortes J. Pertuzumab plus trastuzumab in combination with standard neoadjuvant anthracycline-containing and anthracycline-free chemotherapy regimens in patients with HER2-positive early breast cancer: a randomized phase II cardiac safety study (TRYPHAENA). Ann Oncol. 2013 Sep;24(9):2278-84. doi: 10.1093/annonc/mdt182. Epub 2013 May 22.</citation>
    <PMID>23704196</PMID>
  </results_reference>
  <results_reference>
    <citation>Hamy AS, Belin L, Bonsang-Kitzis H, Paquet C, Pierga JY, Lerebours F, Cottu P, Rouzier R, Savignoni A, Lae M, Reyal F. Pathological complete response and prognosis after neoadjuvant chemotherapy for HER2-positive breast cancers before and after trastuzumab era: results from a real-life cohort. Br J Cancer. 2016 Jan 12;114(1):44-52. doi: 10.1038/bjc.2015.426. Epub 2015 Dec 10. Erratum In: Br J Cancer. 2018 Feb 20;:</citation>
    <PMID>26657653</PMID>
  </results_reference>
  <results_reference>
    <citation>Tashiro H, Nomura Y, Hisamatsu K. [A randomized trial of endocrine therapy, chemotherapy, and chemo-endocrine therapy in advanced breast cancer]. Gan To Kagaku Ryoho. 1990 Dec;17(12):2369-73. Japanese.</citation>
    <PMID>2260873</PMID>
  </results_reference>
  <results_reference>
    <citation>von Minckwitz G, Blohmer JU, Costa SD, Denkert C, Eidtmann H, Eiermann W, Gerber B, Hanusch C, Hilfrich J, Huober J, Jackisch C, Kaufmann M, Kummel S, Paepke S, Schneeweiss A, Untch M, Zahm DM, Mehta K, Loibl S. Response-guided neoadjuvant chemotherapy for breast cancer. J Clin Oncol. 2013 Oct 10;31(29):3623-30. doi: 10.1200/JCO.2012.45.0940. Epub 2013 Sep 3.</citation>
    <PMID>24002511</PMID>
  </results_reference>
  <results_reference>
    <citation>Abe O, Asaishi K, Izuo M, Enomoto K, Koyama H, Tominaga T, Nomura Y, Ohshima A, Aoki N, Tsukada T. Effects of medroxyprogesterone acetate therapy on advanced or recurrent breast cancer and its influences on blood coagulation and the fibrinolytic system. Surg Today. 1995;25(8):701-10. doi: 10.1007/BF00311486.</citation>
    <PMID>8520164</PMID>
  </results_reference>
  <results_reference>
    <citation>Saad ED, Katz A, Buyse M. Overall survival and post-progression survival in advanced breast cancer: a review of recent randomized clinical trials. J Clin Oncol. 2010 Apr 10;28(11):1958-62. doi: 10.1200/JCO.2009.25.5414. Epub 2010 Mar 1.</citation>
    <PMID>20194852</PMID>
  </results_reference>
  <results_reference>
    <citation>Wilcken N, Hornbuckle J, Ghersi D. Chemotherapy alone versus endocrine therapy alone for metastatic breast cancer. Cochrane Database Syst Rev. 2003;2003(2):CD002747. doi: 10.1002/14651858.CD002747.</citation>
    <PMID>12804433</PMID>
  </results_reference>
  <results_reference>
    <citation>Robertson JF, Todd JH, Ellis IO, Elston CW, Blamey RW. Comparison of mastectomy with tamoxifen for treating elderly patients with operable breast cancer. BMJ. 1988 Aug 20-27;297(6647):511-4. doi: 10.1136/bmj.297.6647.511.</citation>
    <PMID>3139179</PMID>
  </results_reference>
  <results_reference>
    <citation>Badwe R, Hawaldar R, Nair N, Kaushik R, Parmar V, Siddique S, Budrukkar A, Mittra I, Gupta S. Locoregional treatment versus no treatment of the primary tumour in metastatic breast cancer: an open-label randomised controlled trial. Lancet Oncol. 2015 Oct;16(13):1380-8. doi: 10.1016/S1470-2045(15)00135-7. Epub 2015 Sep 9.</citation>
    <PMID>26363985</PMID>
  </results_reference>
  <verification_date>June 2019</verification_date>
  <study_first_submitted>December 14, 2016</study_first_submitted>
  <study_first_submitted_qc>December 14, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 16, 2016</study_first_posted>
  <last_update_submitted>June 16, 2019</last_update_submitted>
  <last_update_submitted_qc>June 16, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 19, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tamoxifen</mesh_term>
    <mesh_term>Fluorouracil</mesh_term>
    <mesh_term>Letrozole</mesh_term>
    <mesh_term>Anastrozole</mesh_term>
    <mesh_term>Exemestane</mesh_term>
    <mesh_term>Aromatase Inhibitors</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>We have not decided on this yet</ipd_description>
  </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/NCT02995772
org study id: 049/PEP/08/2011
nct id: NCT02995772
lead sponsor: 
has dmc: No
This study compared long term outcome of stage IIIB/C and IV breast cancer patients treated
      with neoadjuvant hormonal therapy (NAHT) and those treated with neoadjuvant chemotherapy
      (NACT)
This study compared long term outcome of stage IIIB/C and IV breast cancer patients treated
      with neoadjuvant hormonal therapy (NAHT) and those treated with neoadjuvant chemotherapy
      (NACT) between 2011 and 2016.

      The primary end points are overall survival (OS) and progression free survival (PFS) with
      Kaplan Meier.

      This study was approved by Ethical Committee in Dharmais National Cancer Hospital.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall survival
time frame: time from the date of pathological diagnosis until death from any cause and until minimum sample sizes are met and an average 3 years
description: length of time from the date of pathological diagnosis until death from any cause
measure: Progressive free survival
time frame: time from after treatment until tumor progression or death from any cause and until minimum sample sizes are met and an average 3 years
description: length of time from after treatment until tumor progression or death from any cause
arm group label: Neoadjuvant hormonal therapy
arm group type: Active Comparator
description: Neoadjuvant hormonal therapy: Aromatase inhibitors (Arimidex, Femara, Aromasin), Tamoxifen, SOB and AI, SOB and Tamoxifen
arm group label: Neoadjuvant chemotherapy
arm group type: Active Comparator
description: Neoadjuvant chemotherapy: FAC 6 cycles
intervention type: Drug
intervention name: Aromatase Inhibitors (Arimidex)
description: Comparison of efficacy with chemotherapy
arm group label: Neoadjuvant hormonal therapy
other name: Anastrozole
intervention type: Drug
intervention name: Tamoxifen
description: Comparison of efficacy with chemotherapy
arm group label: Neoadjuvant hormonal therapy
other name: Nolvadex
other name: Soltamox
intervention type: Procedure
intervention name: SOB
description: Comparison of efficacy with chemotherapy
arm group label: Neoadjuvant hormonal therapy
other name: Salpingo-oophorectomy Bilateral
intervention type: Drug
intervention name: FAC
description: Comparison of efficacy with hormonal therapy
arm group label: Neoadjuvant chemotherapy
other name: Fluorouracil, Adriamycin, Cytoxan
intervention type: Drug
intervention name: Aromatase Inhibitors (Femara)
description: Comparison of efficacy with chemotherapy
arm group label: Neoadjuvant hormonal therapy
other name: Letrozole
intervention type: Drug
intervention name: Aromatase Inhibitors (Aromasin)
description: Comparison of efficacy with chemotherapy
arm group label: Neoadjuvant hormonal therapy
other name: Exemestane
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Ramadhan Karsono, Doctoral
role: Study Chair
affiliation: Dharmais National Cancer Center Hospital
facility: 
country: Indonesia
citation: Beatson GT. On the Treatment of Inoperable Cases of Carcinoma of the Mamma: Suggestions for a New Method of Treatment, with Illustrative Cases. Trans Med Chir Soc Edinb. 1896;15:153-179. No abstract available.
PMID: 29584099
citation: van de Vijver MJ, He YD, van't Veer LJ, Dai H, Hart AA, Voskuil DW, Schreiber GJ, Peterse JL, Roberts C, Marton MJ, Parrish M, Atsma D, Witteveen A, Glas A, Delahaye L, van der Velde T, Bartelink H, Rodenhuis S, Rutgers ET, Friend SH, Bernards R. A gene-expression signature as a predictor of survival in breast cancer. N Engl J Med. 2002 Dec 19;347(25):1999-2009. doi: 10.1056/NEJMoa021967.
PMID: 12490681
citation: Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: an overview of the randomised trials. Lancet. 2005 May 14-20;365(9472):1687-717. doi: 10.1016/S0140-6736(05)66544-0.
PMID: 15894097
citation: Cardoso F, van't Veer LJ, Bogaerts J, Slaets L, Viale G, Delaloge S, Pierga JY, Brain E, Causeret S, DeLorenzi M, Glas AM, Golfinopoulos V, Goulioti T, Knox S, Matos E, Meulemans B, Neijenhuis PA, Nitz U, Passalacqua R, Ravdin P, Rubio IT, Saghatchian M, Smilde TJ, Sotiriou C, Stork L, Straehle C, Thomas G, Thompson AM, van der Hoeven JM, Vuylsteke P, Bernards R, Tryfonidis K, Rutgers E, Piccart M; MINDACT Investigators. 70-Gene Signature as an Aid to Treatment Decisions in Early-Stage Breast Cancer. N Engl J Med. 2016 Aug 25;375(8):717-29. doi: 10.1056/NEJMoa1602253.
PMID: 27557300
citation: Asad J, Jacobson AF, Estabrook A, Smith SR, Boolbol SK, Feldman SM, Osborne MP, Boachie-Adjei K, Twardzik W, Tartter PI. Does oncotype DX recurrence score affect the management of patients with early-stage breast cancer? Am J Surg. 2008 Oct;196(4):527-9. doi: 10.1016/j.amjsurg.2008.06.021.
PMID: 18809056
citation: Teshome M, Hunt KK. Neoadjuvant therapy in the treatment of breast cancer. Surg Oncol Clin N Am. 2014 Jul;23(3):505-23. doi: 10.1016/j.soc.2014.03.006. Epub 2014 Apr 24.
PMID: 24882348
citation: Mauriac L, MacGrogan G, Avril A, Durand M, Floquet A, Debled M, Dilhuydy JM, Bonichon F. Neoadjuvant chemotherapy for operable breast carcinoma larger than 3 cm: a unicentre randomized trial with a 124-month median follow-up. Institut Bergonie Bordeaux Groupe Sein (IBBGS). Ann Oncol. 1999 Jan;10(1):47-52. doi: 10.1023/a:1008337009350.
PMID: 10076721
citation: Chia YH, Ellis MJ, Ma CX. Neoadjuvant endocrine therapy in primary breast cancer: indications and use as a research tool. Br J Cancer. 2010 Sep 7;103(6):759-64. doi: 10.1038/sj.bjc.6605845. Epub 2010 Aug 10.
PMID: 20700118
citation: Bossuyt V, Provenzano E, Symmans WF, Boughey JC, Coles C, Curigliano G, Dixon JM, Esserman LJ, Fastner G, Kuehn T, Peintinger F, von Minckwitz G, White J, Yang W, Badve S, Denkert C, MacGrogan G, Penault-Llorca F, Viale G, Cameron D; Breast International Group-North American Breast Cancer Group (BIG-NABCG) collaboration. Recommendations for standardized pathological characterization of residual disease for neoadjuvant clinical trials of breast cancer by the BIG-NABCG collaboration. Ann Oncol. 2015 Jul;26(7):1280-91. doi: 10.1093/annonc/mdv161. Epub 2015 May 27.
PMID: 26019189
citation: Chuang E, Paul C, Flam A, McCarville K, Forst M, Shin S, Vahdat L, Swistel A, Simmons R, Osborne M. Breast cancer subtypes in Asian-Americans differ according to Asian ethnic group. J Immigr Minor Health. 2012 Oct;14(5):754-8. doi: 10.1007/s10903-012-9577-7.
PMID: 22286607
citation: Hammond ME, Hayes DF, Dowsett M, Allred DC, Hagerty KL, Badve S, Fitzgibbons PL, Francis G, Goldstein NS, Hayes M, Hicks DG, Lester S, Love R, Mangu PB, McShane L, Miller K, Osborne CK, Paik S, Perlmutter J, Rhodes A, Sasano H, Schwartz JN, Sweep FC, Taube S, Torlakovic EE, Valenstein P, Viale G, Visscher D, Wheeler T, Williams RB, Wittliff JL, Wolff AC; American Society of Clinical Oncology; College of American Pathologists. American Society of Clinical Oncology/College of American Pathologists guideline recommendations for immunohistochemical testing of estrogen and progesterone receptors in breast cancer (unabridged version). Arch Pathol Lab Med. 2010 Jul;134(7):e48-72. doi: 10.5858/134.7.e48.
PMID: 20586616
citation: Marcus DM, Switchenko JM, Prabhu R, O'Regan R, Zelnak A, Fasola C, Mister D, Torres MA. Neoadjuvant Hormonal Therapy is Associated with Comparable Outcomes to Neoadjuvant Chemotherapy in Post-Menopausal Women with Estrogen Receptor-Positive Breast Cancer. Front Oncol. 2013 Dec 27;3:317. doi: 10.3389/fonc.2013.00317. eCollection 2013.
PMID: 24409418
citation: Semiglazov VF, Semiglazov VV, Dashyan GA, Ziltsova EK, Ivanov VG, Bozhok AA, Melnikova OA, Paltuev RM, Kletzel A, Berstein LM. Phase 2 randomized trial of primary endocrine therapy versus chemotherapy in postmenopausal patients with estrogen receptor-positive breast cancer. Cancer. 2007 Jul 15;110(2):244-54. doi: 10.1002/cncr.22789.
PMID: 17538978
citation: Preece PE, Wood RA, Mackie CR, Cuschieri A. Tamoxifen as initial sole treatment of localised breast cancer in elderly women: a pilot study. Br Med J (Clin Res Ed). 1982 Mar 20;284(6319):869-70. doi: 10.1136/bmj.284.6319.869-a. No abstract available.
PMID: 6802332
citation: Rastogi P, Anderson SJ, Bear HD, Geyer CE, Kahlenberg MS, Robidoux A, Margolese RG, Hoehn JL, Vogel VG, Dakhil SR, Tamkus D, King KM, Pajon ER, Wright MJ, Robert J, Paik S, Mamounas EP, Wolmark N. Preoperative chemotherapy: updates of National Surgical Adjuvant Breast and Bowel Project Protocols B-18 and B-27. J Clin Oncol. 2008 Feb 10;26(5):778-85. doi: 10.1200/JCO.2007.15.0235. Erratum In: J Clin Oncol. 2008 Jun 1;26(16):2793.
PMID: 18258986
citation: Schneeweiss A, Chia S, Hickish T, Harvey V, Eniu A, Hegg R, Tausch C, Seo JH, Tsai YF, Ratnayake J, McNally V, Ross G, Cortes J. Pertuzumab plus trastuzumab in combination with standard neoadjuvant anthracycline-containing and anthracycline-free chemotherapy regimens in patients with HER2-positive early breast cancer: a randomized phase II cardiac safety study (TRYPHAENA). Ann Oncol. 2013 Sep;24(9):2278-84. doi: 10.1093/annonc/mdt182. Epub 2013 May 22.
PMID: 23704196
citation: Hamy AS, Belin L, Bonsang-Kitzis H, Paquet C, Pierga JY, Lerebours F, Cottu P, Rouzier R, Savignoni A, Lae M, Reyal F. Pathological complete response and prognosis after neoadjuvant chemotherapy for HER2-positive breast cancers before and after trastuzumab era: results from a real-life cohort. Br J Cancer. 2016 Jan 12;114(1):44-52. doi: 10.1038/bjc.2015.426. Epub 2015 Dec 10. Erratum In: Br J Cancer. 2018 Feb 20;:
PMID: 26657653
citation: Tashiro H, Nomura Y, Hisamatsu K. [A randomized trial of endocrine therapy, chemotherapy, and chemo-endocrine therapy in advanced breast cancer]. Gan To Kagaku Ryoho. 1990 Dec;17(12):2369-73. Japanese.
PMID: 2260873
citation: von Minckwitz G, Blohmer JU, Costa SD, Denkert C, Eidtmann H, Eiermann W, Gerber B, Hanusch C, Hilfrich J, Huober J, Jackisch C, Kaufmann M, Kummel S, Paepke S, Schneeweiss A, Untch M, Zahm DM, Mehta K, Loibl S. Response-guided neoadjuvant chemotherapy for breast cancer. J Clin Oncol. 2013 Oct 10;31(29):3623-30. doi: 10.1200/JCO.2012.45.0940. Epub 2013 Sep 3.
PMID: 24002511
citation: Abe O, Asaishi K, Izuo M, Enomoto K, Koyama H, Tominaga T, Nomura Y, Ohshima A, Aoki N, Tsukada T. Effects of medroxyprogesterone acetate therapy on advanced or recurrent breast cancer and its influences on blood coagulation and the fibrinolytic system. Surg Today. 1995;25(8):701-10. doi: 10.1007/BF00311486.
PMID: 8520164
citation: Saad ED, Katz A, Buyse M. Overall survival and post-progression survival in advanced breast cancer: a review of recent randomized clinical trials. J Clin Oncol. 2010 Apr 10;28(11):1958-62. doi: 10.1200/JCO.2009.25.5414. Epub 2010 Mar 1.
PMID: 20194852
citation: Wilcken N, Hornbuckle J, Ghersi D. Chemotherapy alone versus endocrine therapy alone for metastatic breast cancer. Cochrane Database Syst Rev. 2003;2003(2):CD002747. doi: 10.1002/14651858.CD002747.
PMID: 12804433
citation: Robertson JF, Todd JH, Ellis IO, Elston CW, Blamey RW. Comparison of mastectomy with tamoxifen for treating elderly patients with operable breast cancer. BMJ. 1988 Aug 20-27;297(6647):511-4. doi: 10.1136/bmj.297.6647.511.
PMID: 3139179
citation: Badwe R, Hawaldar R, Nair N, Kaushik R, Parmar V, Siddique S, Budrukkar A, Mittra I, Gupta S. Locoregional treatment versus no treatment of the primary tumour in metastatic breast cancer: an open-label randomised controlled trial. Lancet Oncol. 2015 Oct;16(13):1380-8. doi: 10.1016/S1470-2045(15)00135-7. Epub 2015 Sep 9.
PMID: 26363985
responsible party type: Sponsor
mesh term: Breast Neoplasms
mesh term: Tamoxifen
mesh term: Fluorouracil
mesh term: Letrozole
mesh term: Anastrozole
mesh term: Exemestane
mesh term: Aromatase Inhibitors
sharing ipd: Undecided
ipd description: We have not decided on this yet