Back to resultsOP-1250 (Palazestrant) vs. Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer (OPERA-01)
Primary Purpose
Breast Cancer, Advanced Breast Cancer, Metastatic Breast Cancer
Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
OP-1250
Fulvestrant
Anastrozole
Letrozole
Exemestane
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer
Eligibility Criteria
Key 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 will be allowed. 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 (LHRH) agonist. Key exclusion criteria: Symptomatic visceral disease, imminent organ failure, or any disease burden that makes the participant ineligible for endocrine therapy. Have received prior chemotherapy in the advanced/metastatic setting. Have received prior 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 and others.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
OP-1250 (palazestrant)
Standard of Care Endocrine Therapy
Arm Description
Subjects will receive OP-1250
Subjects will receive Investigator's choice of one of the Standard of Care drugs (fulvestrant, anastrozole, letrozole, or exemestane)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT06016738
First Posted
August 17, 2023
Last Updated
August 31, 2023
Sponsor
Olema Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT06016738
Brief Title
OP-1250 (Palazestrant) vs. Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer
Acronym
OPERA-01
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 15, 2023 (Anticipated)
Primary Completion Date
June 30, 2026 (Anticipated)
Study Completion Date
September 30, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Olema Pharmaceuticals, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This phase 3 clinical study compares the safety and efficacy of 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 at least one endocrine therapy in combination with a CDK4/6 inhibitor.
Detailed Description
This is an international, multicenter, randomized, open-label, active-controlled, phase 3 clinical trial comparing the safety and efficacy of OP-1250 as a single agent to standard of care endocrine therapy of either fulvestrant or an aromatase inhibitor (anastrozole, letrozole, or exemestane) in 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 have included at least one line of endocrine therapy in combination with a CDK 4/6 inhibitor.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Advanced Breast Cancer, Metastatic Breast Cancer, ER Positive Breast Cancer, HER2 Negative Breast Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
510 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
OP-1250 (palazestrant)
Arm Type
Experimental
Arm Description
Subjects will receive OP-1250
Arm Title
Standard of Care Endocrine Therapy
Arm Type
Active Comparator
Arm Description
Subjects will receive Investigator's choice of one of the Standard of Care drugs (fulvestrant, anastrozole, letrozole, or exemestane)
Intervention Type
Drug
Intervention Name(s)
OP-1250
Other Intervention Name(s)
Palazestrant
Intervention Description
Patients will be treated with OP-1250 once daily on a 4 week (28 day) cycle
Intervention Type
Drug
Intervention Name(s)
Fulvestrant
Other Intervention Name(s)
Faslodex
Intervention Description
Patients will be treated with fulvestrant on C1D1, C1D15, and C2D1 in the first 4 week (28 day) cycle, and on Day 1 of every subsequent 4 week (28 day) cycle
Intervention Type
Drug
Intervention Name(s)
Anastrozole
Other Intervention Name(s)
Arimidex
Intervention Description
Patients will be treated with anastrozole once daily on a 4 week (28 day) cycle
Intervention Type
Drug
Intervention Name(s)
Letrozole
Other Intervention Name(s)
Femara
Intervention Description
Patients will be treated with letrozole once daily on a 4 week (28 day) cycle
Intervention Type
Drug
Intervention Name(s)
Exemestane
Other Intervention Name(s)
Aromasin
Intervention Description
Patients will be treated with exemestane once daily on a 4 week (28 day) cycle
Primary Outcome Measure Information:
Title
Progression-Free Survival (PFS)
Description
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 Outcome Measure Information:
Title
Overall Survival (OS)
Description
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key 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 will be allowed.
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 (LHRH) agonist.
Key exclusion criteria:
Symptomatic visceral disease, imminent organ failure, or any disease burden that makes the participant ineligible for endocrine therapy.
Have received prior chemotherapy in the advanced/metastatic setting.
Have received prior 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 and others.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Olema Pharmaceuticals, Inc.
Phone
415-651-7206
Email
OPERA-01@olema.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director, MD
Organizational Affiliation
Olema Pharmaceuticals, Inc.
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
OP-1250 (Palazestrant) vs. Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer
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