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A clinical study to compare giredestrant with fulvestrant, both combined with a targeted therapy (CDK4/6 inhibitor) in people with ER-positive, HER2-negative breast cancer that has come back after adjuvant hormone therapy
A Study to Evaluate Efficacy and Safety of Giredestrant Compared With Fulvestrant (Plus a CDK4/6 Inhibitor), in Participants With ER-Positive, HER2-Negative Advanced Breast Cancer Resistant to Adjuvant Endocrine Therapy (pionERA Breast Cancer)
Cancer Breast Cancer Breast Cancer HER-2 Negative Estrogen Receptor (ER)-Positive
Basic Details
Sponsor
Hoffmann-La Roche
Phase
Phase 3
Trial Identifier
NCT06065748, CO44657, 2022-502980-39-00
Condition
Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer
Official 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
Study Summary
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.
Eligibility Criteria
All
≥18 Years
No
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
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
This page summarises information from public registry websites, such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc. To learn more about this study, see the For Medical Professional tab or visit one of those websites.
The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.
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For the latest version of this information please go to www.forpatients.roche.com