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Participants will receive Investigator's choice of one of the Standard of Care drugs (fulvestrant, anastrozole, letrozole, or exemestane)

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.

Palazestrant

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

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

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

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

Olema Pharmaceuticals, Inc.

Medical Director, MD

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.

This is an international, multicenter, randomized, open-label, active-controlled, phase 3 clinical trial. The purpose of this trial is to compare the safety and efficacy of palazestrant (OP-1250) as a single agent to the standard of care endocrine therapy: either fulvestrant or an aromatase inhibitor (anastrozole, letrozole, or exemestane).

This trial is seeking adult participants with ER+, HER2- advanced or metastatic breast cancer whose disease has relapsed or progressed on 1 or 2 prior lines of standard-of-care endocrine therapy for metastatic breast cancer. Prior lines of therapy must include one line of endocrine therapy in combination with a CDK 4/6 inhibitor. In the dose-selection part of the trial, approximately 120 participants will be randomized to one of the two doses of palazestrant or to the standard-of-care endocrine therapy. Thereafter, approximately 390 participants will be randomized to palazestrant at the selected dose or to the standard-of-care endocrine therapy.

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

A Phase 3 Randomized, Open-Label Study of OP-1250 Monotherapy vs Standard of Care for the Treatment of ER+, HER2- Advanced or Metastatic Breast Cancer Following Endocrine and CDK 4/6 Inhibitor Therapy (OPERA-01)

To evaluate the number of participants with adverse events

To evaluate the number of participants reducing the dose of palazestrant

To evaluate the number of participants discontinuing palazestrant

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.

To compare OS 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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
OP-1250 (Palazestrant) vs. Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer	NCT06016738	Breast Cancer Advanced Breast... Metastatic Brea... ER Positive Bre... HER2 Negative B...	Palazestrant Fulvestrant Anastrozole Letrozole Exemestane	18 Years -	Olema Pharmaceuticals, Inc.
OP-1250 (Palazestrant) vs. Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer	NCT06016738	Breast Cancer Advanced Breast... Metastatic Brea... ER Positive Bre... HER2 Negative B...	Palazestrant Fulvestrant Anastrozole Letrozole Exemestane	18 Years -	Olema Pharmaceuticals, Inc.

Spots Global Cancer Trial Database for palazestrant

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