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Brief Title: CFI-400945 and Durvalumab in Patients With Advanced Triple Negative Breast Cancer
Official Title: A Phase II Study of CFI-400945 and Durvalumab in Patients With Advanced/Metastatic Triple Negative Breast Cancer (TNBC)
Study ID: NCT04176848
Brief Summary: The purpose of this study is to find out the effect that CFI-400945 and durvalumab have on breast cancer.
Detailed Description: CFI-400945 is a new type of drug for breast cancer. Laboratory tests show that it works by blocking a specific protein called Polo-like Kinase 4 (PLK4) that is involved in cancer cell growth. CFI-400945 may slow down the growth of cancer cells or may cause cancer cells to die. This drug has been shown to shrink tumours in animals and has been studied in more than 60 patients. It appears to be well tolerated with few side effects. CFI-400945 seems promising but it is not clear if it can offer better results than standard therapy. Durvalumab is a new type of drug for many types of cancer. Durvalumab is an immunotherapy drug and not a chemotherapy drug. Laboratory tests show that it works by allowing the immune system (PD-1 and PD-L1 interaction) to detect your cancer and reactivating the immune response. This may help to slow down the growth of cancer or may cause cancer cells to die. Durvalumab has been shown to shrink tumours in animals and has been studied in more than 6000 people. In laboratory studies, when used together with CFI-400945, results seem promising but it is not clear if it can offer better results than standard treatment alone. This is the first time that the combination of CFI-400945 and durvalumab has been tested in patients.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
BCCA - Cancer Centre for the Southern Interior, Kelowna, British Columbia, Canada
Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton, Ontario, Canada
Kingston Health Sciences Centre, Kingston, Ontario, Canada
Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
University Health Network, Toronto, Ontario, Canada
Name: David Cescon
Affiliation: University Health Network, PMH, Toronto ON
Role: STUDY_CHAIR
Name: Andrew Robinson
Affiliation: Cancer Centre of Southeastern Ontario at Kingston, ON
Role: STUDY_CHAIR