Clincosm LogoSign in Get a demo

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

Sponsor
Asan Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT02001506
Collaborator
(none)
250
Enrollment
1
Location
2
Arms
37
Duration (Months)
6.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

To investigate feasibility of FEC3-D3 regimen in neoadjuvant setting in terms of comparable efficacy and shorter duration across all subtypes.

Study Design

Study Type:
Interventional
Actual Enrollment :
250 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Study Start Date :
Nov 1, 2012
Actual Primary Completion Date :
Dec 1, 2015
Actual Study Completion Date :
Dec 1, 2015

Arms and Interventions

Arm Intervention/Treatment
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

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

    		•
    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

    Outcome Measures

    Primary Outcome Measures

    1. pathologic complete response (pCR) between two arms [within the first 30 days (plus or minus 3 days) after surgery]

    Secondary Outcome Measures

    1. 3 year-disease free survival between two arms [3 year after surgery]

      Correlation of pCR and Ki-67 expression at baseline and D14 tumor specimen 3 year-disease free survival Correlation of pCR and biomarkers such as Ki-67 expression

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Asan Medical Center Seoul Korea, Republic of 05505

    Sponsors and Collaborators

    • Asan Medical Center

    Investigators

    • Principal Investigator: Sung-Bae Kim, MD, PhD, Asan Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sung-Bae Kim, Professor, Asan Medical Center
    ClinicalTrials.gov Identifier:
    NCT02001506
    Other Study ID Numbers:
    • 2012-0116
    First Posted:
    Dec 5, 2013
    Last Update Posted:
    Aug 29, 2017
    Last Verified:
    Aug 1, 2017
    Keywords provided by Sung-Bae Kim, Professor, Asan Medical Center
    breast cancer
    neoadjuvant
    different number of chemotherapy cycles
    Additional relevant MeSH terms:
    Breast Neoplasms
    Docetaxel
    Epirubicin

    Study Results

    No Results Posted as of Aug 29, 2017