A Phase 1b/2, Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combinations In Patients With Metastatic Breast Cancer (ELEVATE)

Primary Outcome Measure: Determine the recommended Phase 2 dose (RP2D) of elacestrant in combination with each of the other study drugs.

Inclusion Criteria:

  1. Women or men aged ≥18 years (or the minimum age of consent in accordance with the local law), at the time of informed consent signature. Female patients may be either postmenopausal, premenopausal, or perimenopausal.
  2. Histopathologically or cytologically confirmed ER+, HER2-, breast cancer, per local laboratory.
  3. At least one measurable lesion as per RECIST version 1.1 or a mainly lytic bone lesion.
  4. ECOG performance status of 0 or 1.
  5. Patient has adequate bone marrow and organ function, as defined by the following laboratory values:
    1. Absolute neutrophil count (ANC) ≥1.5 × 109/L
    2. Platelets ≥100 × 109/L
    3. Hemoglobin ≥9.0 g/dL
    4. Potassium, sodium, calcium (corrected for serum albumin) and magnesium CTCAE grade ≤1
    5. Cockcroft-Gault based creatinine clearance ≥50 mL/min.
    6. Serum albumin ≥3.0 g/dL (≥30 g/L)
    7. In absence of liver metastases, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3.0 × ULN. If the patient has liver metastases, ALT and AST ≤ 5 × ULN
    8. Total serum bilirubin <1.5 × ULN except for patients with Gilbert's syndrome who may be included if the total serum bilirubin is ≤3.0 × ULN or direct bilirubin ≤ 1.5 × ULN.

Exclusion Criteria:

  1. Active or newly diagnosed CNS metastases, including meningeal carcinomatosis.
  2. Patients with advanced, symptomatic visceral spread, that are at risk of life-threatening complications in the short term.
  3. Prior chemotherapy or elacestrant in the advanced/metastatic setting.
  4. Patient has a concurrent malignancy or history of invasive malignancy within 3 years of enrollment, with the exception of basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix that has completed curative therapy.
  5. Uncontrolled significant active infections.
    1. Patients known to be HIV+ are allowed as long as they have undetectable viral load at baseline.
  6. Documented pneumonitis/ILD prior to Cycle 1 Day 1.
  7. Major surgery within 28 days before starting trial therapy.
  8. Inability to take oral medications, refractory or chronic nausea, gastrointestinal conditions, history of malabsorption syndrome, or any other uncontrolled gastrointestinal condition that impact the absorption of the study drug.
  9. Known intolerance to elacestrant or any of its excipients.
  10. Females of childbearing potential who:
    1. Within 28 days before starting trial therapy, did not use a highly effective method of contraception.
    2. Do not agree to use a highly effective method of contraception throughout the entire study period and for 28 days after trial therapy discontinuation
  11. Men who do not agree to abstain from donating sperm, or to use a highly effective method of contraception, during the course of the treatment period and for 120 days thereafter.
  12. Patient is currently receiving or received any of the following medications prior to first dose of trial therapy:
    1. Investigational anti-cancer therapy within 14 days (28 days for anticancer antibody based treatment) or 5 half-lives, whichever is shorter,
    2. Known strong or moderate inducers or inhibitors of cytochrome P450 (CYP) 3A4 within 14 days or 5 half-lives, whichever is shorter (Refer to this Drug Interactions explanation).
    3. Herbal preparations/medications within 7 days.
    4. Vaccination, including but not limited to vaccination against COVID-19, during the 7 days prior to randomization.
  13. Evidence of ongoing alcohol or drug abuse as assessed by the investigator.

Other inclusion/exclusion criteria are present. Please contact the study team for a complete list.

Stemline Therapeutics, Inc.
Principal Investigator(s)
Pavani Chalasani, MD
Contact Phone Number
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