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ONCOVIDA | Santiago, Chile

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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-Positive, HER2-Negative Advanced Breast Cancer Resistant to Adjuvant Endocrine Therapy (pionERA Breast Cancer)

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Roche

Status and phase

Enrolling
Phase 3

Conditions

Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer

Treatments

Diagnostic Test: FoundationOne Liquid CDx Assay (F1LCDx)
Drug: Giredestrant
Drug: Ribociclib
Drug: Abemaciclib
Drug: Fulvestrant
Drug: LHRH Agonist
Drug: Palbociclib

Study type

Interventional

Funder types

Industry

Identifiers

NCT06065748
CO44657
2022-502980-39-00 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment

1,050 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

1,050 participants in 2 patient groups

Giredestrant + Investigator's Choice of CDK4/6i
Experimental group
Description:
Participants in the experimental arm will receive giredestrant plus the investigator's choice of CDK4/6 inhibitor (CDK4/6i): palbociclib, ribociclib, or abemaciclib.
Treatment:
Drug: LHRH Agonist
Drug: Palbociclib
Drug: Abemaciclib
Drug: Ribociclib
Drug: Giredestrant
Diagnostic Test: FoundationOne Liquid CDx Assay (F1LCDx)
Fulvestrant + Investigator's Choice of CDK4/6i
Active Comparator group
Description:
Participants in the control arm will receive fulvestrant plus the investigator's choice of CDK4/6 inhibitor (CDK4/6i): palbociclib, ribociclib, or abemaciclib.
Treatment:
Drug: LHRH Agonist
Drug: Palbociclib
Drug: Fulvestrant
Drug: Abemaciclib
Drug: Ribociclib
Diagnostic Test: FoundationOne Liquid CDx Assay (F1LCDx)

Trial contacts and locations

232

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Central trial contact

Reference Study ID Number: CO44657 https://forpatients.roche.com/

Data sourced from clinicaltrials.gov

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