Breast Cancer Foundation NZ
DIAmOND
Advanced Breast Cancer clinical trials for HER2+
This study aims to find out if the combination of anti-HER2 therapy with PD-L1 inhibitor and CTLA4 inhibitor will reactivate anti-tumour immune response and improve clinical outcomes in trastuzumab-resistant, advanced HER2+ breast cancer.
Study details
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.
There will be two cohorts of patients:
- Patients receiving tremelimumab with durvalumab and trastuzumab for 16 weeks (induction phase) followed by durvalumab and trastuzumab every 3 weeks (treatment phase) for a total treatment period of 12 months.
- Patients receiving a single 300 mg 'priming dose' of tremelimumab with durvalumab and trastuzumab, followed by durvalumab and trastuzumab every 3 weeks for up to 12 months.
First Cohort:
Induction phase:
Participants will receive:
- 4 doses of durvalumab (1 dose every 4 weeks), administered intravenously;
- 4 doses of tremelimumab (1 dose every 4 weeks), administered intravenously;
- 16 doses of trastuzumab (1 dose every week), administered intravenously.
Treatment phase:
Participants will receive durvalumab and trastuzumab every three weeks for 12 doses (total 36 weeks). Tremelimumab will not be given.
Research blood samples will be taken every nine weeks, before each dose of study treatment.
Second Cohort:
Participants in the 'priming dose' cohort will receive:
- 1 dose of Tremelimumab with durvalumab and trastuzumab; then
- 18 doses of durvalumab (1 dose every three weeks) for up to 1 year; plus
- 18 doses of trastuzumab (1 dose every three weeks) for up to 1 year
Research blood samples will be taken at week 10 and week 16 of the study.
All Participants:
Oestrogen-receptor-positive patients will also start or continue endocrine therapy (aromatase inhibitor and/or GnRH agonist).
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.
Participants will be clinically assessed prior to each 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.
Australia
Bendigo Hospital, Bendigo
Fiona Stanley Hospital, Murdoch
Flinders Medical Centre, Bedford Park
Mater Cancer Care Centre , South Brisbane
Peter MacCallum Cancer Centre, Melbourne
Royal Hobart Hospital, Hobart
St George Hospital, Kogarah
Sunshine Coast University Hospital, Birtinya
Westmead Hospital, Westmead
Contact:
Corinna BeckmoreIf you think you might be a candidate for this trial, use the contact details supplied, or talk to your doctor.
Want to access a trial that's not in your area? It's not always possible, but if you're interested, email us at intouch@bcf.org.nz
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