This study aims to find out if the combination of trastuzumab (anti-HER2 therapy) with durvalumab (PD-L1 inhibitor) and tremelimumab (CTLA4 inhibitor) will reactivate anti-tumour immune response and improve clinical outcomes in trastuzumab-resistant, advanced HER2-positive breast cancer.
Who is it for?
You may be eligible for this study if you are 18 years or older, male or female, and have HER2+ metastatic or incurable breast cancer that has progressed on previous trastuzumab treatment.
Up to four weeks before starting study treatment, all participants will have either a CT Scan, MRI, or PET with dedicated CT Scan, provide a research tumour biopsy of the cancer (taken within one year of starting the study) and research blood tests.
During this phase, participants will receive:
Participants will be clinically assessed prior to each study treatment. Two core biopsies, if feasible, will be taken from the same site as the initial biopsy about three weeks after starting study treatment. A research blood sample will be taken before the 3rd dose of study treatment.
Participants will receive durvalumab and trastuzumab every three weeks for 12 doses (total 36 weeks). Tremelimumab will not be given. Participants will be clinically assessed prior to each study treatment. . A research blood sample will be taken every nine weeks, before each dose of study treatment. During the study, heart function tests (ECHO or MUGA) will be performed every three months as per standard of care, or as clinically indicated.
The full length of treatment is 52 weeks (one year). After completing study treatment, patients will be followed every three months by either clinic visits or via telephone.
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