Active — Not RecruitingPhase 3

A Study Evaluating the Efficacy and Safety of Giredestrant Plus Everolimus Compared With the Physician's Choice of Endocrine Therapy Plus Everolimus in Participants With Estrogen Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer (evERA Breast Cancer)

United States373 participantsStarted 2022-08-03

Plain-language summary

This Phase III, randomized, open-label, multicenter study will evaluate the efficacy and safety of giredestrant plus everolimus compared with the physician's choice of endocrine therapy plus everolimus in participants with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer who have had previous treatment with cyclin-dependent kinase 4/6 inhibitors (CDK4/6is) and endocrine therapy, either in the locally advanced/metastatic or the adjuvant setting.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Locally advanced unresectable or metastatic adenocarcinoma of the breast, not amenable to treatment with curative intent
✓. Documented estrogen receptor-positive (ER+) tumor and HER2-negative tumor, assessed locally
✓. Ability to provide a blood sample for circulating-tumor deoxyribonucleic acid (ctDNA) Estrogen Receptor 1 (ESR1) mutation status determination by central testing
✓. Prior endocrine therapy (ET) in combination with cyclin-dependent kinase 4/6 inhibitors in either setting as follows:
✓. Measurable disease as defined per RECIST v.1.1 or evaluable bone metastases. Patients with evaluable bone disease in the absence of measurable disease outside of the bone must have at least one predominantly lytic bone lesion confirmed by computed tomography (CT) or magnetic resonance imaging (MRI) which can be followed
✓. Eastern Cooperative Oncology Group Performance Status 0-1
✓. For women who are premenopausal or perimenopausal and for men: treatment with approved luteinizing hormone-releasing hormone (LHRH) agonist therapy for the duration of study treatment

Exclusion criteria

What they're measuring

Progression-Free Survival, as Determined by the Investigator According to RECIST v1.1, in the ESR1m Subpopulation and ITT Population

Timeframe: From randomization until the first occurrence of disease progression or death from any cause, whichever occurs first (up to 42 months)

Trial details

NCT IDNCT05306340

SponsorGenentech, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-07-16

View on ClinicalTrials.gov More Estrogen Receptor (ER)-Positive, HER2-negative, Locally Advanced or Metastatic Breast Cancer trials