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Research

SOLTI-0701 SORAFENIB FASEII

Research

Research

Clinicaltrial.gov identifier:
Status:
Closed
Scenario:
Locally Advanced or Metastatic
Tumour subtype:
HR+ TNBC
Phase:
Phase II
Drug/Intervention:
Sorafenib

A Phase IIb Study to evaluate the efficacy and safety of Sorafenib compared to placebo when administered in combination with capecitabine in patients with locally advanced or metastatic breast cancer

A Multinational Double-Blind, Randomized Phase 2b Study Evaluating the Efficacy and Safety of Sorafenib Compared to Placebo when Administered in Combination with Capecitabine in Patients with Locally Advanced or Metastatic Breast Cancer.

EUDRACT 2007-000290-32

Sponsors

SOLTI

Principal investigators

José Baselga, MD

Vall d'Hebron University Hospital, Medical Oncology Service

Related publications

Article
Clinical presentation and management of hand-foot skin reaction associated with sorafenib in combination with cytotoxic chemotherapy: experience in breast cancer
Article
Sorafenib in combination with capecitabine: an oral regimen for patients with HER2-negative locally advanced or metastatic breast cancer
Congress Communications
Phase IIb double-blind, randomized, placebo-controlled trials for the, efficacy and safety of sorafenib in patients (PTS) with metastatic or locally advanced breast cancer (BC): review of the trials to investigate the effects of sorafenib in BC (TIES) program.
Congress Communications
SOLTI-0701: a multinational double-blind, randomized phase 2b study evaluating the efficacy and safety of sorafenib compared to placebo when administered in combination with capecitabine in patients with locally advanced or metastatic breast cancer.
Congress Communications
Management of hand-foot skin reaction (HFSR)/hand-foot syndrome (HFS) in SOLTI-0701: a double-blind, randomized phase IIb study comparing sorafenib (SOR) versus placebo (PL) in combination with capecitabine (CAP) in patients (PTS) with advanced breast cancer (BC).
Congress Communications
Multivariate analysis (MVA) of progression-free survival (PFS) in two phase IIb, multinational, double-blind, randomized, placebo (PL)-controlled trials evaluating sorafenib (SOR) plus standard chemotherapy in patients (PTS) with HER2-negative locally advanced or metastatic breast cancer (BC).
Congress Communications
Sorafenib plus capecitabine in patients with triple-negative advanced breast cancer: subgroup analysis of SOLTI-0701, a double-blind, randomised, placebo-controlled phase 2b study.
Congress Communications
SOLTI-0701: a double-blind, randomised phase 2b study evaluating sorafenib (SOR) in combination with capecitabine (CAP) in patients (PTS) with advanced breast cancer (BC).
Congress Communications
Overall survival data from SOLTI-0701: a multinational, double-blind, placebo-controlled, randomized phase 2b study evaluating the oral combination of sorafenib and capecitabine in patients with locally advanced or metastatic HER2-negative breast cancer.
Congress Communications
Sorafenib (SOR) plus chemotherapy (CRX) in patients (PTS) with triple-negative (TN) advanced (ADV) breast cancer (BC): subgroup analyses of 3, double-blind, randomised, placebo (PL)-controlled phase 2b trials from the TIES (trials to investigate the efficacy of sorafenib) BC program.
Congress Communications
Final results of SOLTI-0701, a phase 2b study of the oral combination of sorafenib (SOR) and capecitabine (CAP) in patients (PTS)with locally advanced or metastatic HER2-negative breast cancer (BC).
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