This clinical trial is investigating the efficacy and safety of GDC-9545 (aka Giredestrant) combined with palbociclib compared with Letrozole combined with palbociclib in patients with oestrogen receptor positive, HER2-negative, locally advanced or metastatic breast cancer.
Who is the trial for? Women or men with confirmed hormone receptor positive, HER2-negative locally advanced or metastatic breast cancer. Patients must have progressed greater than 12 months after completing adjuvant treatment with endocrine therapy. They should also have no serious medical conditions and a life expectancy of greater than six months. It does include patients with bone-only disease. Auckland City Hospital and Waikato Hospital are New Zealand sites for this trial.
View this link for full trial information.
Please consult with your doctor or medical team if you are interested in participating in this trial.
15 May 2023
Update: 21 August 2026:
In March 2026 Genentech provided this update on the Phase III persevERA study in ER-positive advanced breast cancer:
- persevERA Breast Cancer study did not meet the primary objective of a statistically significant improvement in progression-free survival, but a numerical improvement was observed
- Giredestrant plus palbociclib was well tolerated and adverse events were consistent with the known safety profiles of each individual treatment
- Genentech is committed to transforming ER-positive breast cancer care, anchored by the landmark success of lidERA in early-stage disease and evERA in the advanced setting
- The FDA recently accepted the New Drug Application based on evERA data; Phase III lidERA data will be submitted to the FDA in the coming weeks
- persevERA is the first of two distinct Phase III studies in the first-line setting; pionERA study of giredestrant in combination with physician’s choice of CDK4/6 inhibitor in endocrine-resistant ER-positive breast cancer is expected to readout in 2027.
