NCT00593697

The Synergism Or Long Duration (SOLD) Study

A Randomized Phase III Study Comparing Trastuzumab Plus Docetaxel (HT) Followed by 5-FU, Epirubicin, and Cyclophosphamide (FEC) to the Same Regimen Followed by Single-agent Trastuzumab as Adjuvant Treatments for Early Breast Cancer

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,168 (actual)
• Sponsor: Finnish Breast Cancer Group · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to compare disease-free survival (DFS) of women treated with concomitant trastuzumab plus docetaxel followed by FEC to that of the women treated with the same regimen followed by single-agent trastuzumab to complete one year of trastuzumab administration as adjuvant treatments of early HER2-positive breast cancer.

Conditions

• Breast Neoplasms

Interventions

Type	Name	Description
DRUG	trastuzumab (9 weeks) + docetaxel	Patients diagnosed with early breast cancer with a high risk of disease recurrence will be randomly allocated to one of the following 2 arms in a 1:1 ratio: A. Weekly or 3-weekly trastuzumab plus 3-weekly docetaxel (3 cycles) (HT) -\> 3-weekly FE75C (3 cycles) (HT x3 -\>FE75C x3) B. Weekly or 3-weekly trastuzumab plus 3-weekly docetaxel (3 cycles) (HT) -\> 3-weekly FE75C (3 cycles) -\> trastuzumab to complete 1 year (14 3-weekly infusions) (HT x3 -\>FE75C x3 -\> H3wkly x14)
DRUG	trastuzumab (9 weeks) + docetaxel + CEF + trastuzumab (up to 51 weeks)	Weekly or 3-weekly trastuzumab plus 3-weekly docetaxel (3 cycles) (HT) -\> 3-weekly FE75C (3 cycles) -\> trastuzumab to complete 1 year (14 3-weekly infusions) (HT x3 -\>FE75C x3 -\> H3wkly x14)

Timeline

• Start date: 2008-01-01
• Primary completion: 2014-11-01
• Completion: 2014-11-01
• First posted: 2008-01-15
• Last updated: 2015-03-06

Locations

1 site across 1 country: Finland