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

Breast Cancer Clinical Trial

— Neo-shorter  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02001506
• Other study ID #: 2012-0116
• Status: Completed
• Phase: Phase 3
• First received: November 19, 2013
• Last updated: August 26, 2017
• Start date: November 2012
• Est. completion date: December 2015

Study information

• Verified date: August 2017
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pathologic complete response (pCR) between two arms		within the first 30 days (plus or minus 3 days) after surgery
Secondary	3 year-disease free survival between two arms	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	3 year after surgery