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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

Study Description
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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
Breast Cancer Drug: FEC3-D3 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
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Study Type : Interventional  (Clinical Trial)
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 : November 2012
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Docetaxel

Arms and Interventions
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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
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Primary Outcome Measures :
  1. pathologic complete response (pCR) between two arms [ Time Frame: within the first 30 days (plus or minus 3 days) after surgery ]

Secondary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02001506


Locations
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Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 05505
Sponsors and Collaborators
Asan Medical Center
Investigators
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Principal Investigator: Sung-Bae Kim, MD, PhD Asan Medical Center
More Information
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Responsible Party: Sung-Bae Kim, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT02001506    
Other Study ID Numbers: 2012-0116
First Posted: December 5, 2013    Key Record Dates
Last Update Posted: August 29, 2017
Last Verified: August 2017
Keywords provided by Sung-Bae Kim, Asan Medical Center:
breast cancer
neoadjuvant
different number of chemotherapy cycles
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Docetaxel
Epirubicin
Antineoplastic Agents
 Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors