Breast Cancer Clinical Trial
Official title:
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
The objective of this phase-III trial is to compare the efficacy and safety of sorafenib in combination with capecitabine versus capecitabine in combination with placebo in the treatment of subjects with locally advanced or metastatic HER2-negative breast cancer who are resistant to or have failed prior taxane and an anthracycline or for whom further anthracycline therapy is not indicated. After signing consent there can be up to 28 days before starting the treatment during which time a number of tests will be carried out which will include tumor evaluations and medical history. The following tests and evaluations will have to be done within 7 days of the start of treatment,on Day 1 of every cycle and at the end of study: Electrocardiogram, blood tests, patient quality of life questionnaires and a complete physical exam and vital signs. Treatment will be given in 21 day cycles with sorafenib/placebo to be taken every day for 21 days and capecitabine to be taken for the first 14 days. Patients will come in weekly for the first 6 weeks and then on Day1 for every cycle after the first 2 cycles. During the weekly visits the subjects will be check for any side effects and blood draws will happen for the study on Day 1 of each cycle. Subjects will be followed for overall survival.
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 drugs.
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.
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