Informations générales (source: ClinicalTrials.gov)
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
Interventional
Phase 3
Hoffmann-La Roche (Voir sur ClinicalTrials)
décembre 2023
décembre 2028
27 juillet 2025
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
the investigator's choice of a CDK4/6 inhibitor (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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Cancerologie Grand Montpellier - 34070 - Montpellier - France | Contact (sur clinicalTrials) | ||||
| Centre Eugene Marquis - 35042 - Rennes - France | Contact (sur clinicalTrials) | ||||
| Centre Francois Baclesse - 14076 - Caen - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Saint Louis - 17019 - La Rochelle - France | Contact (sur clinicalTrials) | ||||
| Centre Jean Perrin - 63011 - Clermont Ferrand - France | Contact (sur clinicalTrials) | ||||
| Centre Leon Berard - 69373 - Lyon - France | Contact (sur clinicalTrials) | ||||
| Centre Oscar Lambret - 59020 - Lille - France | Contact (sur clinicalTrials) | ||||
| Hopital Jean Minjoz - 25030 - Besancon - France | Contact (sur clinicalTrials) | ||||
| ICO Paul Papin - 49055 - Angers - France | Contact (sur clinicalTrials) | ||||
| Institut Jean Godinot - 51056 - Reims CEDEX - France | Contact (sur clinicalTrials) | ||||
| Institut Sainte Catherine - 84082 - Avignon - France | Contact (sur clinicalTrials) | ||||
| IUCT Oncopole - 31100 - Toulouse - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion 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 an archived tumor sample if a recent
tumor sample is not available for testing)
- Confirmed ESR1 mutation status (ESR1m versus ESR1nmd) in baseline circulating tumor
DNA (ctDNA) through central laboratory testing
- Resistance to prior adjuvant endocrine therapy (ET), which is defined as having
relapsed with prior standard adjuvant ET, on-treatment after >/=12 months or
off-treatment within 12 months of completion. Prior use of adjuvant CDK4/6i is
allowed (if relapse occurred >/=12 months since completion).
- No prior systemic anti-cancer therapy for advanced disease
- 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
- For pre/perimenopausal women and for men: willing to undergo and maintain treatment
with approved LHRH agonist therapy (as per local guidelines) for the duration of
study treatment
- 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 an archived tumor sample if a recent
tumor sample is not available for testing)
- Confirmed ESR1 mutation status (ESR1m versus ESR1nmd) in baseline circulating tumor
DNA (ctDNA) through central laboratory testing
- Resistance to prior adjuvant endocrine therapy (ET), which is defined as having
relapsed with prior standard adjuvant ET, on-treatment after >/=12 months or
off-treatment within 12 months of completion. Prior use of adjuvant CDK4/6i is
allowed (if relapse occurred >/=12 months since completion).
- No prior systemic anti-cancer therapy for advanced disease
- 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
- For pre/perimenopausal women and for men: willing to undergo and maintain treatment
with approved LHRH agonist therapy (as per local guidelines) for the duration of
study treatment
- 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