Advanced or Metastatic Breast Cancer
Conditions
Interventions
Elacestrant 345 mg is administered orally once daily.
Sponsors
Nakauma Akiyo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Must have a histologically- or cytologically-proven diagnosis of adenocarcinoma of the breast with evidence of either locally advanced disease not amenable to resection or radiation therapy with curative intent or metastatic disease not amenable to curative therapy 2.Must be appropriate candidates for endocrine monotherapy (e.g., not in visceral crisis requiring chemotherapy, primary endocrine resistance) 3.Must have ER + and HER2- tumor status confirmed per local laboratory testing. 4.Must have previously received at least 1 and no more than 2 lines of endocrine therapy, either as monotherapy or as a combination therapy with another agent (eg, PI3K inhibitor), for mBC 5.Must have disease progression during or within 28 days of completion of prior treatment with a CDK4/6 inhibitor in combination with either fulvestrant or an AI (this counts as a line of prior endocrine therapy) for mBC 6.Must have received no more than 1 line of cytotoxic chemotherapy in the advanced/metastatic setting
Exclusion criteria
Exclusion criteria: 1.Prior treatment with elacestrant or investigational or approved selective estrogen receptor degrader (SERD) or ER antagonist (eg, imlunestrant, camizestrant, giredestrant, vepdegestrant, bazedoxifene, lasofoxifene, palazestrant) 2.Prior treatment with an ADC for advanced/metastatic breast cancer 3.Prior anti-cancer or investigational drug treatment within the following windows: a.Fulvestrant treatment (last injection) < 42 days before first dose of study drug b.Any other endocrine therapy < 14 days before first dose of study drug c.Chemotherapy or other anti-cancer therapy (excluding endocrine therapy) <14 days before first dose of study drug d.Any investigational anti-cancer drug therapy < 28 days or 5 half-lives (whichever is shorter) before the first dose of study drug. Enrollment of participants whose most recent therapy was an investigational agent should be discussed with Sponsor e.Bisphosphonates or Receptor Activator of Nuclear factor Kappa-B Ligand (RANKL) inhibitors initiated or dose changed < 3 months prior to first dose of study drug 4.Presence of symptomatic metastatic visceral disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| IRC-assessed PFS | — |
Secondary
| Measure | Time frame |
|---|---|
| - Safety and tolerability, assessed by AEs, serious adverse events (SAEs), dose modifications, clinical laboratory parameters - Investigator-assessed PFS - OS | — |
Contacts
Public ContactAkiyo Nakauma
CMIC Co., Ltd.
Outcome results
None listed