Breast Cancer Foundation NZ
pionERA Trial
Advanced Breast Cancer clinical trials for ER+
This is a Phase III, randomized, open-label multicenter study that will evaluate the efficacy and safety of giredestrant compared with fulvestrant, both in combination with a CDK4/6 inhibitor (either palbociclib, ribociclib or abemaciclib), in participants with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer who have developed resistance to adjuvant endocrine therapy.
Who is it for?
Inclusion Criteria:
- Both men and women, 18 years or over
- ER+/HER2- locally advanced or metastatic breast cancer (unable to be treated with curative intent)
- Confirmed ESR1 mutation status (ESR1m versus ESR1nmd) in baseline circulating tumor DNA (ctDNA) through central laboratory testing
- Resistance to prior adjuvant endocrine therapy (ET). This is defined as having relapsed after 12 months or more of starting endocrine treatment for early breast cancer or having relapsed within 12 months of completion of endocrine treatment for early breast cancer. Prior use of adjuvant CDK4/6i is allowed (if relapse occurred 12 months or more since completion).
- No prior systemic therapy for advanced cancer
- Measurable disease as defined per RECIST v.1.1 or non-measurable (including bone-only) disease
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1
- pre/perimenopausal women and men must be willing to also take LHRH agonist therapy (as per local guidelines) for the duration of study treatment
Exclusion Criteria:
- Prior systemic therapy (e.g., prior chemotherapy, immunotherapy, or biologic therapy) for locally advanced unresectable or metastatic breast cancer
- Prior treatment with another SERD (e.g., fulvestrant, oral SERDs) or novel ER-targeting agents
- Advanced, symptomatic, visceral spread that is at risk of life-threatening complications in the short term
- Active cardiac disease or history of cardiac dysfunction
- Clinically significant history of liver disease
What is involved?
If you are eligible for this study and agree to participate you will be randomly allocated to:
Experimental group: Giredestrant AND a CDK4/6 inhibitor (either palbociclib, ribociclib or abemaciclib).
Comparator group: Fulvestrant AND CDK4/6 inhibitor (either palbociclib, ribociclib, or abemaciclib).
Please note: abemaciclib is not yet available in New Zealand, so for participants in New Zealand it is likely you will receive palbociclib or ribociclib.
This trial is being conducted in multiple countries worldwide, including the USA, Europe, Asia, Australia and New Zealand.
For more information click here
New Zealand
Palmerston North Hospital
Whangarei Hospital
Australia
QLD
SA
VIC
If 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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For Advanced Breast Cancer
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