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A study to Evaluate Efficacy and Safety of Giredestrant Compared with Fulvestrant (plus a CDK4/6 inhibitor), in Participants with ER+ HER2-Negative Advanced Breast Cancer Resistant to Adjuvant Endocrine Therapy (pionERA Breast Cancer)
EU CTIS ID: 2022-502980-39-00
What this study is testing
To evaluate the efficacy of giredestrant compared with fulvestrant in the ESR1 mutation detected (ESR1m) subgroup and full analysis set (FAS) on the basis of progression-free survival (PFS)
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Confirmed ESR1 mutation status in baseline ctDNA
- Resistance to prior standard adjuvant ET, defined as relapse on-treatment after ≥ 12 months or off-treatment within 12 months of completion. If adjuvant ET included a CDK4/6i, capecitabine, or S-1 relapse should have occurred ≥ 12 months since completion of CDK4/6i such treatment
- Measurable disease as defined per RECIST v.1.1 or non-measurable (including bone-only) disease
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 - 1
- Locally advanced or metastatic adenocarcinoma of the breast not amenable to treatment with curative intent, with documented ER+ HER2- status assessed locally based on the most recent tumor biopsy (or archived tumor sample if a recent tumor sample is not available for testing)
You likely can't join if
- Prior treatment with a SERD (e.g., fulvestrant, investigational)
- Advanced, symptomatic, visceral spread that is at risk of life-threatening complications
- Active cardiac disease or history of cardiac dysfunction
- Clinically significant history of liver disease
- Prior systemic therapy (e.g., prior chemotherapy, immunotherapy, or biologic therapy) for locally advanced unresectable or metastatic breast cancer. Prior therapy for contralateral, local, and/or regional BC treated with curative surgery is allowed
The study team makes the final eligibility decision.
Where it's taking place
- Chile
- Peru
- Mexico
- Costa Rica
- Argentina
- New Zealand
- Korea, Republic of
- Hong Kong
- South Africa
- India
- Canada
- Australia
- Singapore
- Guatemala
- Israel
- Turkey
- Brazil
- Kenya
- United States
- China
+ 3 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chile; Peru; Mexico; Costa Rica; Argentina; New Zealand and 17 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.