| Title |
A Phase III Randomized, Open-Label Study Evaluating Efficacy and Safety of Giredestrant Compared With Fulvestrant, Both Combined With a CDK4/6 Inhibitor, in Patients With Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer With Resistance to Prior Adjuvant Endocrine Therapy |
| Protocole ID |
pionERA Breast Cancer |
| ClinicalTrials.gov ID |
NCT06065748 |
| Cancer Type(s) |
Breast |
| Phase |
Phase III |
| Stage |
|
| Study Type |
Clinical |
| Drug |
Giredestrant comparé au fulvestrant |
| Institution |
CENTRE HOSPITALIER DE L'UNIVERSITE DE MONTREAL
|
| City |
|
| Principal Investigator |
Dr. Danielle Charpentier
|
| Coordinator |
Ana Lydia Tkalec
514-890-8000 poste 14186
|
| Status |
Recruiting |
| Activation Date |
|
| Eligibility Criteria |
- Locally advanced or metastatic adenocarcinoma of the breast, not amenable to treatment with curative intent
- Documented estrogen receptor-positive (ER+), HER2-negative (HER2-) tumor assessed locally on the most recent tumor biopsy (or archived tumor sample)
- Confirmed ESR1 mutation status (ESR1m vs. ESR1nmd) in baseline circulating tumor DNA (ctDNA) through central laboratory testing
- Resistance to prior adjuvant endocrine therapy (ET). Prior use of neo/adjuvant CDK4/6i is allowed.
- No prior systemic anti-cancer therapy for advanced disease
- Measurable disease as defined per RECIST v.1.1 or non-measurable bone-only disease
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1
- For pre/perimenopausal women and for men: treatment with LHRH agonist therapy (as per local guidelines) for the duration of study treatment is required
|
| 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
|
| |
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Groupe d'étude en oncologie du Québec