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OpenTrials
Completed

NCT Number: NCT02001506

Neoadjuvant Chemotherapy of 6 Cycles vs 8 Cycles in Node Positve Breast Cancer

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

20 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Asan Medical Center

Seoul, 05505, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FEC3-D3

Drug

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

Primary outcomes

  1. pathologic complete response (pCR) between two arms

    Time frame: within the first 30 days (plus or minus 3 days) after surgery

Secondary outcomes

  1. 3 year-disease free survival between two arms

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Registry information

Official study 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

Acronym: Neo-shorter

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Dec 5, 2013
Registry last updated
Aug 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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