A Phase III Randomized, Double Blind, Placebo-controlled Trial Comparing Capecitabine Plus Sorafenib Versus Capecitabine Plus Placebo in the Treatment of Locally Advanced or Metastatic HER2-Negative Breast Cancer
Research summary (NRES, UK):
Breast cancer is the most commonly diagnosed cancer in women and the leading cause of
cancer-related death among women worldwide.
However, despite advances in treatment of the early-stage disease, about 25-40% of patients
will develop recurrence or spread to other parts of the body that is largely incurable. The
average survival of patients with breast cancer that has spread to other parts of the body
(metastasis) is 2 to 3 years after diagnosis, and although a number of treatment options are
available, including various chemotherapy agents, no single standard of care exists.
The study drug (Sorafenib) works by inhibiting certain pathways in the body that contribute
to tumour growth and the formation of new blood vessels (angiogenesis). Angiogenesis plays
an important role in the development, transformation and spread of breast cancer.
Capecitabine is an approved chemotherapy drug for patients whose breast cancer has spread to
other parts of the body (metastatic) and is not responsive to other classes of chemotherapy
Data from a Phase IIb clinical study suggests that there is a role for the combination of
Sorafenib and Capecitabine to treat locally advanced or metastatic breast cancer.
Patients in this confirmatory Phase III study will be randomly assigned to receive either:
- Capecitabine + Sorafenib
- Capecitabine + placebo ("dummy medication" with no active drug)
Participants will continue to receive treatments until there is radiographic or clinical
progression of disease, side effects which require them to withdraw, pregnancy, protocol
non-compliance or withdrawal of consent. Therefore length of participation will vary for
individuals. This study is expected to close 31 March 2013.
This is a multicentre study which will take place across Europe, North and South America,
Asia, Australia and South Africa. It is anticipated that approximately 519 participants will
be recruited worldwide.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Progression-free survival (PFS): radiological assessment according to RECIST 1.1 criteria for progression
Date of randomization of first patient to 48 months later
Bayer Study Director
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
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