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The Synergism Or Long Duration (SOLD) Study

NCT00593697 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2168

Last updated 2015-03-06

No results posted yet for this study

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

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)

Sponsors & Collaborators

  • Finnish Breast Cancer Group

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2014-11-30
Completion
2014-11-30

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00593697 on ClinicalTrials.gov