A Proof of Concept, Window Trial of the IMmunological Effects of AveLumab and Aspirin in Triple-Negative Breast Cancer
Status:
Withdrawn
Trial end date:
2021-02-28
Target enrollment:
Participant gender:
Summary
This research is being done because the investigators are looking for new and better ways to
treat a type of breast cancer called triple negative breast cancer. This type of breast
cancer can be more difficult to treat than other types of breast cancer as it does not
respond to drugs such as hormonal therapies. One type of treatment that looks promising is
immunotherapy using new drugs called immune checkpoint inhibitors.
Immune checkpoints help to regulate the immune system and can stop the immune system from
attacking cancer cells. Immune checkpoint inhibitors block this 'off-switch' and aim to help
the immune system control the cancer. These drugs have been very effective in other cancers
such as melanoma and are now being tested in breast cancer.
In this study patients will receive an immune checkpoint inhibitor called avelumab. Half the
patients on the study will also receive aspirin tablets for approximately 18 days as the
investigators wish to compare the effects of avelumab alone versus in combination with
aspirin.
Patients will attend hospital approximately five times in order to complete all necessary
study assessments. The first visit screens patients for suitability, after which a baseline
visit will collect the first of two breast tissue biopsies. At the third visit a single dose
of Avelumab will be given via an infusion (a drip in the forearm). Patients will then return
approximately two weeks later for a second breast tissue biopsy before having a final follow
up visit another two weeks later. Blood and urine samples will be taken at various visits
throughout the study to help us learn more about the effects these treatments may have on the
immune system and on breast cancer cells.