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

PHASE3RECRUITING

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.

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

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.

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Adequate hematologic, hepatic, and renal functions.

Female participants can be pre-, peri- or postmenopausal.

Male and pre- or peri-menopausal female participants must be willing to take a GnRH (or LHRH) agonist.

Exclusion criteria

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.

Any contraindications to the selected standard-of-care endocrine therapy in the local prescribing information.

Symptomatic central nervous system metastases, carcinomatous meningitis, leptomeningeal disease, or a spinal cord compression that require immediate treatment.

Clinically significant comorbidities such as significant cardiac or cerebrovascular disease, gastrointestinal disorders that could affect absorption of study treatment.

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2023-11-16

Primary completion: 2026-06-30

Study completion finish: 2027-09-30

Study type

TREATMENT

Phase

PHASE3

Trial ID

NCT06016738

Intervention or treatment

DRUG: Palazestrant

DRUG: Fulvestrant

DRUG: Anastrozole

DRUG: Letrozole

DRUG: Exemestane

Conditions

• Breast Cancer
• Advanced Breast Cancer
• Metastatic Breast Cancer
• ER Positive Breast Cancer
• HER2 Negative Breast Carcinoma

Condition: Breast Cancer, Advanced Breast Cancer and more
DRUG: Palazestrant and other drugs
Gosford, New South Wales, Australia and more
Sponsor: Olema Pharmaceuticals, Inc.

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Clinical Trial Site

Research sites nearby

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Clinical Trial Site
Gosford, New South Wales, Australia
Clinical Trial Site
Westmead, New South Wales, Australia
Clinical Trial Site
Adelaide, South Australia, Australia
Clinical Trial Site
Ballarat Central, Victoria, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Palazestrant (OP-1250) Participants will receive Palazestrant	DRUG: 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.
ACTIVE_COMPARATOR: Standard of Care Endocrine Therapy Participants will receive Investigator's choice of one of the Standard of Care drugs (fulvestrant, anastrozole, letrozole, or exemestane)	DRUG: Fulvestrant Participants will be treated with fulvestrant on C1D1, C1D15, and then on Day 1 of every subsequent 4 week (28 day) cycle

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Dose-Selection Part: Incidence of adverse events	To evaluate the number of participants with adverse events	From Date of Randomization up to 16 weeks
Dose-Selection Part: Incidence of dose reduction	To evaluate the number of participants reducing the dose of palazestrant	From Date of Randomization up to 16 weeks
Dose-Selection Part: Incidence of drug discontinuation	To evaluate the number of participants discontinuing palazestrant	From Date of Randomization up to 16 weeks
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.	From Date of Randomization until Disease Progression or Death Due to Any Cause (estimated as up to 2 years)

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
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.	From Date of Randomization until Death Due to Any Cause (estimated as up to 4 years)

Frequently Asked Questions

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References

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