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Trial record 2 of 99 for:    FEC

Neoadjuvant Chemotherapy of 6 Cycles vs 8 Cycles in Node Positve Breast Cancer (Neo-shorter)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02001506
Recruitment Status : Completed
First Posted : December 5, 2013
Last Update Posted : August 29, 2017
Sponsor:
Information provided by (Responsible Party):
Sung-Bae Kim, Asan Medical Center

Tracking Information
First Submitted Date  ICMJE November 19, 2013
First Posted Date  ICMJE December 5, 2013
Last Update Posted Date August 29, 2017
Study Start Date  ICMJE November 2012
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 28, 2013)
pathologic complete response (pCR) between two arms [ Time Frame: within the first 30 days (plus or minus 3 days) after surgery ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02001506 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 28, 2013)
3 year-disease free survival between two arms [ Time Frame: 3 year after surgery ]
  1. Correlation of pCR and Ki-67 expression at baseline and D14 tumor specimen
  2. 3 year-disease free survival
  3. Correlation of pCR and biomarkers such as Ki-67 expression
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Neoadjuvant Chemotherapy of 6 Cycles vs 8 Cycles in Node Positve Breast Cancer
Official Title  ICMJE A Randomized Phase III Trial of Neoadjuvant Chemotherapy With 3 Cycles of FEC Followed by 3 Cycles of Docetaxel Versus 4 Cycles of Adriamycin Plus Cyclophosphamide Followed by 4 Cycles of Docetaxel in Node-positive Breast Cancer
Brief Summary Various regimens and schedule as neoadjuvant chemotherapy regimens were investigated and sequential treatment of anthracyclines followed by taxanes, which has shown superior pathologic complete respone (pCR) rate (NSABP-B27 study) is widely used until now. Considering the proven efficacy and tolerable toxicity of 3 cycles of FEC followed by 3 cycles of Docetaxel (FEC3-D3) compared to FEC 6 cycles in adjuvant chemotherapy (PACS 01 trial), use of FEC3-D3 regimen in neoadjuvant setting will be feasible with acceptable efficacy and further reduce the duration of neoadjuvant chemotherapy.
Detailed Description To investigate feasibility of FEC3-D3 regimen in neoadjuvant setting in terms of comparable efficacy and shorter duration across all subtypes.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE Drug: FEC3-D3

Fluorouracil 500 mg/m2, every 3 weeks Epirubicin 100 mg/m2, every 3 weeks Cyclophosphamide 500, every 3 weeks

Docetaxel 75 mg/m2, every 3 weeks

Other Names:
  • 5-FU
  • Pharmorubicin
  • Cytoxan
  • Docetaxel
Study Arms  ICMJE
  • Active Comparator: FEC3-D3

    3 cycles of FEC followed by 3 cycles of Docetaxel

    Fluorouracil 500 mg/m2, every 3 weeks Epirubicin 100 mg/m2, every 3 weeks Cyclophosphamide 500, every 3 weeks

    Docetaxel 75 mg/m2, every 3 weeks

    Intervention: Drug: FEC3-D3
  • No Intervention: AC4-D4

    4 cycles of Adriamycin plus Cyclophosphamide (AC) followed by 4 cycles of Docetaxel

    Adriamycin 60 mg/m2, every 3 weeks Cyclophosphamide 600 mg/m2, every 3 weeks

    Docetaxel 75 mg/m2, every 3 weeks

Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 26, 2017)
250
Original Estimated Enrollment  ICMJE
 (submitted: November 28, 2013)
560
Actual Study Completion Date  ICMJE December 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Performance status 0 or 1
  • Clinically stage 2 or 3 with histologically proven lymph node involvement
  • Tumor or lymph node greater than 1.5 cm

Exclusion Criteria:

  • Pregnancy or lactation
  • Prior chemotherapy or radiotherapy for any malignancy
  • Documented history of cardiac disease contraindicating anthracyclines
  • Currently active infection
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02001506
Other Study ID Numbers  ICMJE 2012-0116
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sung-Bae Kim, Asan Medical Center
Study Sponsor  ICMJE Asan Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sung-Bae Kim, MD, PhD Asan Medical Center
PRS Account Asan Medical Center
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP