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)

Running, not enrolling · Phase 3

Conditions studied: Estrogen Receptor (ER)-Positive, HER2-negative, Locally Advanced or Metastatic Breast Cancer

In brief

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.

Key facts

Study ID: NCT05306340
Run by: Genentech, Inc.
People needed: 373
Starts: 2022-08-03
Expected to finish: 2026-10-15
Last updated by the study team: 2026-06-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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:
Metastatic setting: Disease progression after ≥6 months on ET plus CDK4/6 inhibitor in the locally advanced or metastatic setting. If ET plus CDK4/6 inhibitor is not the most recent therapy, then patient must also have had disease progression after ≥4 months on most recent ET
Adjuvant Setting: Relapse either while taking or within 12 months of exposure to combination adjuvant ET and CDK4/6 inhibitor. Patients must have taken at least 12 months of adjuvant ET, 6 months of which was in combination with a CDK4/6 inhibitor.
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

You may not qualify if…

Prior treatment with another oral selective estrogen receptor degrader (SERD), proteolysis targeting chimera (PROTAC), complete estrogen receptor antagonist (CERAN), novel oral selective estrogen receptor modulator (SERM), or everolimus in any setting. Prior fulvestrant is allowed if treatment was terminated at least 28 days prior to randomization. Prior treatment with tamoxifen is allowed.
Progression on more than 2 prior lines of systemic endocrine therapy in the locally advanced unresectable or metastatic breast cancer setting
Prior chemotherapy for locally advanced unresectable or metastatic disease
Treatment with strong Cytochrome P450 3A4 (CYP3A4) inhibitors or inducers within 14 days or 5 drug elimination half-lives (whichever is longer) prior to randomization
Treatment with any investigational therapy within 28 days prior to initiation of study treatment
Major surgery, chemotherapy, radiotherapy, or other anti-cancer therapy within 14 days prior to randomization
History of any other malignancy other than breast cancer within 5 years prior to screening, except for appropriately treated carcinoma in situ of the cervix, nonmelanoma skin carcinoma, papillary thyroid cancer treated with surgery, Stage I endometrial cancer, or other non-breast cancers at very low risk of recurrence
Advanced, symptomatic, visceral spread that is at risk of life-threatening complications in the short term
Known active uncontrolled or symptomatic central nervous system (CNS) metastases, carcinomatous meningitis, or leptomeningeal disease
Active cardiac disease or history of cardiac dysfunction
Known clinically significant history of liver disease consistent with Child-Pugh Class B or C including active viral or other hepatitis virus, current alcohol abuse, or cirrhosis
Active inflammatory bowel disease, chronic diarrhea, short bowel syndrome, or major upper gastrointestinal (GI) surgery including gastric resection
Interstitial lung disease or severe dyspnea at rest or requiring oxygen therapy
Serious infection requiring oral or intravenous (IV) antibiotics, or other clinically significant infection, within 14 days prior to randomization
Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study
Known allergy or hypersensitivity to any of the study drugs or any of their excipients
For premenopausal or perimenopausal women and for men: known hypersensitivity to LHRH agonists
Pregnant or breastfeeding

Where it is running

Arizona Oncology Associates, PC-CASA — Tucson, Arizona, United States
University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
Alta Bates Summit Medical Center — Berkeley, California, United States
Beverly Hills Cancer Center — Beverly Hills, California, United States
TOI Clinical Research — Cerritos, California, United States
Women's Cancer Care — Fresno, California, United States
Scripps Health — La Jolla, California, United States
Los Angeles Hematology Oncology Medical Group — Los Angeles, California, United States
University of California, Irvine Medical Center — Orange, California, United States
Yale Cancer Center — New Haven, Connecticut, United States
Mount Sinai Medical Center — Miami Beach, Florida, United States
Orlando Health Cancer Institute — Orlando, Florida, United States
Northwest Georgia Oncology Centers PC - Marietta — Marietta, Georgia, United States
Summit Cancer Care PC — Savannah, Georgia, United States
Northwestern University — Chicago, Illinois, United States
Springfield Clinic — Springfield, Illinois, United States
Indiana University Melvin and Bren Simon Cancer Center — Indianapolis, Indiana, United States
University of Kansas Cancer Center — Westwood, Kansas, United States
Eastern Maine Medical Center — Brewer, Maine, United States
New England Cancer Specialists — Scarborough, Maine, United States
Anne Arundel Medical Center — Annapolis, Maryland, United States
University of Maryland Greenebaum Cancer Center — Baltimore, Maryland, United States
Mercy Medical Center — Baltimore, Maryland, United States
Dana Farber Cancer Institute — Boston, Massachusetts, United States
Alaska Oncology & Hematology, LLC — Anchorage, Alaska, United States

Full record on ClinicalTrials.gov

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