Breast cancer study halted
In an adjuvant study for early stage breast cancer, 6 participants of the study have developed signs and symptoms of congestive heart failure. The study is through the Swiss drug maker Roche. The drug Avastin has brought the company $2.69 billion in U.S. Sales in the year 2008. Avastin has been studied and approved for use in colon, lung, brain, and kidney cancers in the advanced stages. The U.S. National Cancer Institute and the U.S. Eastern Cooperative Oncology Group have stopped admitting patients to the study because of the development of heart failure symptoms in 6 patients. This development has halted the breast cancer study.
According to study protocol, enrollment must be suspended if 6 or more cases of congestive heart failure are seen in the first 200 patients. A Roche spokesman has reported that 5 of the cases have resolved. All of the 3,439 current participants will be allowed to stay in the breast cancer study, however they are required to talk with their physicians and sign a new consent form. The study includes those with breast cancer in the early stages.
Avastin has been approved for advanced cancers. Avastin stops cancer growth by preventing and blocking the formation of blood vessels. This then prevents the cancer from getting the nutrients it needs to grow and spread. Studies for advanced cancers, including advanced breast cancer, have been completed and approved for use. Now Roche has begun studies for early stage breast cancer and colorectal cancer.
A previous study earlier this year for early stages of colorectal cancer has been halted as well. This is due to the same development of congestive heart failure. The breast cancer study has shown the signs and symptoms of heart failure to be consistent with the drug Avastin profile.
Signs and symptoms of breast cancer include a lump, nipple drainage when not lactacting, a sore on the breast that does not heal, and any changes in the breast different from the woman’s normal changes that may occur from month to month.
A safety monitoring board will evaluate the data that has come forth and determine the next steps. This will be done in consultation with groups that are running the trial, regulators and the company. Another study called Beatrice is studying women with a very severe form of breast cancer. This study is going according to plan and it has almost met its enrollment goal.
Source: Clinical Trials