SOLTI

SOLTI
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SOLTI – Contact Details
Country:
Spain
Group:
Grupo Espanol de Estudio Tratamiento y otras Estrategias
Experimentales en Tumores Solidos (SOLTI)
Chair:
Dr H. Cortes-Funes MD, PhD
Chairman of
Scientific
Committee:
Dr J. Baselga, MD, PhD
Website:
www.gruposolti.org
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A phase III randomized, controlled trial of myocet, trastuzumab and
paclitaxel versus trastuzumab and paclitaxel for first line therapy of
metastatic breast cancer.
Coordinator(s):
J. Baselga MD, PhD
Summary:
Final Protocol Released in Jannuary 2006
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The target accrual is 600 randomized patients, 300 in each Arm
Objective:
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The primary objectives of this trial are to demonstrate the efficacy and
cardiac safety of Myocet when given in combination with trastuzumab
and paclitaxel in patients with HER2⫹ metastatic breast cancer.
SOLTI – Study Details
Title:
Scheme:
Arm A
Stratification Criteria:
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Hormone receptors
Age ⬎50 or ⱕ50 years
Prior anthracycline use
Geographic area
Randomization
No prior chemo for
metastatic disease
and HER2⫹ by FISH
Myocet: 50 mg/m2q 3 weeks ⬎maximum 6 cycles
Paclitaxel: 80 mg/m2 weekly ⬎treat to progression or toxicity
Trastuzumab: 2 mg/kg weekly (4 mg/kg load Cycle 1 Week 1) ⬎
treat to progression or toxicity
Arm B
Paclitaxel: 80 mg/m2 weekly ⬎treat to progression or toxicity
Trastuzumab: 2 mg/kg weekly (4 mg/kg load Cycle 1 Week 1) ⬎
treat to progression or toxicity
Update:
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Related
Publications:
None available
Topics:
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Keywords:
Myocet HER2 positive patients, metastatic breast cancer, doxorubicin,
trastuzumab
Clinical Trial Submission in March 2006.
Anthracyclines
Cardiac function
HER2 positive patients
Metastatic breast cancer
Taxanes
Trastuzumab
441
Downloaded from http:/www.cambridge.org/core. IP address: 78.47.27.170, on 23 Dec 2016 at 04:12:01, subject to the Cambridge Core terms
of use, available at http:/www.cambridge.org/core/terms. http://dx.doi.org/10.1017/S1470903106009357