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

ConditionsBreast CancerAdvanced Breast CancerMetastatic Breast CancerER Positive Breast CancerHER2 Negative Breast Carcinoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorOlema Pharmaceuticals, Inc.

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Adult female or male participants.

ER+, HER2- locally advanced or metastatic breast cancer that is not amenable to curative therapy.

Evaluable disease (measurable disease or bone-only disease).

Previously received a CDK4/6 inhibitor in combination with an endocrine therapy in the advanced setting. One additional line of ET as a monotherapy is allowed. Duration of the most recent prior ET must be at least 6 months.

Disqualifiers

Symptomatic visceral disease, imminent organ failure, or any other reason that makes the participant ineligible for endocrine monotherapy.

Previously received chemotherapy in the advanced/metastatic setting.

Previously received treatment with elacestrant or an investigational estrogen receptor-directed therapy.

History of allergic reactions to study treatment.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Palazestrant

    Drug

    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

    Drug

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

  • Anastrozole

    Drug

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

  • Letrozole

    Drug

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

  • Exemestane

    Drug

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

Treatment groups

510 Participants
are divided into 2 treatment groups
Group A: Palazestrant (OP-1250)Experimental treatment 1 intervention
Group B: Standard of Care Endocrine TherapyActive comparator 4 interventions

Trial outcomes

Primary outcomes

1

Dose-Selection Part: Incidence of adverse events

To evaluate the number of participants with adverse events

Time frame
From Date of Randomization up to 16 weeks
2

Dose-Selection Part: Incidence of dose reduction

To evaluate the number of participants reducing the dose of palazestrant

Time frame
From Date of Randomization up to 16 weeks
3

Dose-Selection Part: Incidence of drug discontinuation

To evaluate the number of participants discontinuing palazestrant

Time frame
From Date of Randomization up to 16 weeks
4

Trial: Progression-Free Survival (PFS)

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.

Time frame
From Date of Randomization until Disease Progression or Death Due to Any Cause (estimated as up to 2 years)

Secondary outcomes

1

Trial: Overall Survival (OS)

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.

Time frame
From Date of Randomization until Death Due to Any Cause (estimated as up to 4 years)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Olema Pharmaceuticals, Inc.

Lead sponsor

Source ClinicalTrials.gov
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