OP-1250 (Palazestrant) vs. Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer

Condition(s) studied

Investigational drug(s) / intervention(s)

Palazestrant: Participants will be treated with palazestrant once daily on a 4 week (28 day) cycle. Doses evaluated in the dose-selection part will be 120 mg once daily and 90 mg once daily.

Fulvestrant: Participants will be treated with fulvestrant on C1D1, C1D15, and then on Day 1 of every subsequent 4 week (28 day) cycle

Anastrozole: Participants will be treated with anastrozole once daily on a 4 week (28 day) cycle

Letrozole: Participants will be treated with letrozole once daily on a 4 week (28 day) cycle

Exemestane: Participants will be treated with exemestane once daily on a 4 week (28 day) cycle

Study summary

This phase 3 clinical trial compares the safety and efficacy of palazestrant (OP-1250) to the standard-of-care options of fulvestrant or an aromatase inhibitor in women and men with breast cancer whose disease has advanced on one endocrine therapy in combination with a CDK4/6 inhibitor.

Eligibility

Primary outcome measure(s)

• Dose-Selection Part: Incidence of adverse events — From Date of Randomization up to 16 weeks
  To evaluate the number of participants with adverse events
• Dose-Selection Part: Incidence of dose reduction — From Date of Randomization up to 16 weeks
  To evaluate the number of participants reducing the dose of palazestrant
• Dose-Selection Part: Incidence of drug discontinuation — From Date of Randomization up to 16 weeks
  To evaluate the number of participants discontinuing palazestrant
• Trial: Progression-Free Survival (PFS) — From Date of Randomization until Disease Progression or Death Due to Any Cause (estimated as up to 2 years)
  To compare PFS, based on a Blinded Independent Review Committee (BIRC) assessment, between arms of OP-1250 and standard-of-care treatment. This will be assessed separately in populations of ESR1-mutation detected and ESR1-mutation not detected participants.

Trial sites (233)

+ 193 more sites — see the full list on the official registry below.

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