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BIG 1-010 SOLD

The Synergism Or Long Duration (SOLD) Study is 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

WHAT

 
The aim of SOLD is to compare the efficacy of two different treatment regimens for patients with early-stage human epidermal growth factor receptor 2 [HER2]-positive breast cancer: the anti-HER2 treatment (trastuzumab) given for 9 weeks concomitantly with adjuvant chemotherapy, compared with the same regimen plus single-agent trastuzumab administered for 1 year, which is the current standard.

The primary objective is to compare the Disease-free survival (DFS) between the two groups of patients. Researchers will also analyse the overall survival (OS), cardiac and other adverse events as well as the quality of life of the patients.
 

 

WHY / OBJECTIVES 

 
The trial hypothesis is that anti-HER2 treatment (trastuzumab) given for 9 weeks concomitantly with adjuvant chemotherapy is not inferior in efficacy compared with the same regimen plus single-agent trastuzumab administered for 1 year, which is the current standard.

Should this hypothesis be confirmed by the study results, the interest in study regimens that consist of brief anti-HER2 treatment given concomitantly with synergistic or additive agents will likely increase. Short treatments have several potential advantages. They may be less cardiotoxic, they may require no cardiac monitoring, they require fewer hospital visits, and they are less costly.

Administration of potentially synergistic agents with trastuzumab might be more important than extending administration of trastuzumab. This is where the name of the SOLD trial comes from.
 

HOW

 
Upon registration in the study, patients were randomly allocated to one of the two following arms:

 

 - trastuzumab (9 weeks) + docetaxel +CEF

 - trastuzumab (9 weeks) + docetaxel + CEF + trastuzumab (up to 51 weeks)

Participants will be followed up for a minimum of 8 years post-randomization or until death.
 

WHO

Patients


Women of 18 years old or older, diagnosed with early HER2 positive breast cancer with a high risk of disease recurrence.

In total 2,176 patients were recruited (patients accrual was officially closed in December 2016).
 

WHO

Research Groups 

 
This study is coordinated and sponsored by the Finnish Breast Cancer Group (FBCG), and it is conducted under the umbrella of the Breast International Group (BIG).

Collaborating academic partners:

Finnish Breast Cancer Group (FBCG), and Breast International Group (BIG), including sites from Belgium, Iceland, New Zealand, Serbia, Sweden, and the United Kingdom.

 

WHEN

 
The total number of patients enrolled in the study was reached in December 2014.

 

Data are currently being analysed, with the expectation to present the study results at a medical conference and to the public in the near future.
 

WHERE

 

A total of 63 centres from 7 countries (Belgium, Finland, Iceland, New Zealand, Serbia, Sweden, UK) participated in SOLD.

 


RELATED PUBLICATIONS
 

Not yet applicable.


ClinicalTrials.gov Identifier:
 NCT00593697
 

Last update:  24 April 2017




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