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New England Cancer Specialists | Scarborough, ME

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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)

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Genentech

Status and phase

Enrolling
Phase 3

Conditions

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

Treatments

Drug: Fulvestrant
Drug: Dexamethasone Mouth Rinse
Drug: LHRH Agonist
Drug: Giredestrant
Drug: Tamoxifen
Drug: Exemestane
Drug: Everolimus

Study type

Interventional

Funder types

Industry

Identifiers

NCT05306340
2022-000199-20 (EudraCT Number)
ML43171

Details and patient eligibility

About

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.

Enrollment

320 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Locally advanced unresectable or metastatic adenocarcinoma of the breast, not amenable to treatment with curative intent

  2. Documented estrogen receptor-positive (ER+) tumor and HER2-negative tumor, assessed locally

  3. Ability to provide a blood sample for circulating-tumor deoxyribonucleic acid (ctDNA) Estrogen Receptor 1 (ESR1) mutation status determination by central testing

  4. 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.
  5. 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

  6. Eastern Cooperative Oncology Group Performance Status 0-1

  7. For women who are premenopausal or perimenopausal and for men: treatment with approved luteinizing hormone-releasing hormone (LHRH) agonist therapy for the duration of the study treatment

Exclusion criteria

  1. 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.
  2. Progression on more than 2 prior lines of systemic endocrine therapy in the locally advanced unresectable or metastatic breast cancer setting
  3. Prior chemotherapy for locally advanced unresectable or metastatic disease
  4. 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
  5. Treatment with any investigational therapy within 28 days prior to initiation of study treatment
  6. Major surgery, chemotherapy, radiotherapy, or other anti-cancer therapy within 14 days prior to randomization
  7. 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
  8. Advanced, symptomatic, visceral spread that is at risk of life-threatening complications in the short term
  9. Known active uncontrolled or symptomatic central nervous system (CNS) metastases, carcinomatous meningitis, or leptomeningeal disease
  10. Active cardiac disease or history of cardiac dysfunction
  11. 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
  12. Active inflammatory bowel disease, chronic diarrhea, short bowel syndrome, or major upper gastrointestinal (GI) surgery including gastric resection
  13. Interstitial lung disease or severe dyspnea at rest or requiring oxygen therapy
  14. Serious infection requiring oral or intravenous (IV) antibiotics, or other clinically significant infection, within 14 days prior to randomization
  15. 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
  16. Known allergy or hypersensitivity to any of the study drugs or any of their excipients
  17. For premenopausal or perimenopausal women and for men: known hypersensitivity to LHRH agonists
  18. Pregnant or breastfeeding

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

320 participants in 2 patient groups

Giredestrant plus Everolimus
Experimental group
Treatment:
Drug: Everolimus
Drug: Giredestrant
Drug: Dexamethasone Mouth Rinse
Drug: LHRH Agonist
Physician's Choice of Endocrine Therapy plus Everolimus
Active Comparator group
Description:
The physician's choice of endocrine therapy is defined as either exemestane, fulvestrant, or tamoxifen.
Treatment:
Drug: Everolimus
Drug: Exemestane
Drug: Tamoxifen
Drug: Dexamethasone Mouth Rinse
Drug: LHRH Agonist
Drug: Fulvestrant

Trial contacts and locations

215

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Central trial contact

Reference Study ID Number: ML43171 https://forpatients.roche.com/

Data sourced from clinicaltrials.gov

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