OP-1250 (Palazestrant) vs. Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer (OPERA-01)
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| ClinicalTrials.gov Identifier: NCT06016738 |
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Recruitment Status :
Recruiting
First Posted : August 30, 2023
Last Update Posted : April 12, 2024
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Sponsor:
Olema Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Olema Pharmaceuticals, Inc.
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Brief 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Breast Cancer Advanced Breast Cancer Metastatic Breast Cancer ER Positive Breast Cancer HER2 Negative Breast Carcinoma | Drug: Palazestrant Drug: Fulvestrant Drug: Anastrozole Drug: Letrozole Drug: Exemestane | Phase 3 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 510 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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) |
| Actual Study Start Date : | November 16, 2023 |
| Estimated Primary Completion Date : | June 30, 2026 |
| Estimated Study Completion Date : | September 30, 2027 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Breast cancer
MedlinePlus related topics:
Breast Cancer
| Arm | Intervention/treatment |
|---|---|
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Experimental: Palazestrant (OP-1250)
Participants will receive Palazestrant
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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.
Other Name: OP-1250 |
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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)
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Drug: Fulvestrant
Participants will be treated with fulvestrant on C1D1, C1D15, and then on Day 1 of every subsequent 4 week (28 day) cycle Drug: Anastrozole Participants will be treated with anastrozole once daily on a 4 week (28 day) cycle Drug: Letrozole Participants will be treated with letrozole once daily on a 4 week (28 day) cycle Drug: Exemestane Participants will be treated with exemestane once daily on a 4 week (28 day) cycle |
Primary Outcome Measures :
- Dose-Selection Part: Incidence of adverse events [ Time Frame: From Date of Randomization up to 16 weeks ]To evaluate the number of participants with adverse events
- Dose-Selection Part: Incidence of dose reduction [ Time Frame: 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 [ Time Frame: From Date of Randomization up to 16 weeks ]To evaluate the number of participants discontinuing palazestrant
- Trial: Progression-Free Survival (PFS) [ Time Frame: 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.
Secondary Outcome Measures :
- Trial: Overall Survival (OS) [ Time Frame: From Date of Randomization until Death Due to Any Cause (estimated as up to 4 years) ]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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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 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.
Key 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06016738
Contacts
| Contact: Olema Pharmaceuticals, Inc. | 415-651-7206 | OPERA-01@olema.com |
Locations
| United States, California | |
| Clinical Trial Site | Recruiting |
| Fountain Valley, California, United States, 92708 | |
| Clinical Trial Site | Recruiting |
| Los Angeles, California, United States, 90027 | |
| United States, Colorado | |
| Clinical Trial Site | Recruiting |
| Grand Junction, Colorado, United States, 81505 | |
| United States, Connecticut | |
| Clinical Trial Site | Recruiting |
| Danbury, Connecticut, United States, 06810 | |
| United States, Florida | |
| Clinical Trial Site | Recruiting |
| Margate, Florida, United States, 33063 | |
| Clinical Trial Site | Recruiting |
| Orlando, Florida, United States, 32804 | |
| United States, Illinois | |
| Clinical Trial Site | Recruiting |
| Urbana, Illinois, United States, 61801 | |
| United States, New Mexico | |
| Clinical Trial Site | Recruiting |
| Farmington, New Mexico, United States, 87401 | |
| United States, New York | |
| Clinical Trial Site | Recruiting |
| Port Jefferson Station, New York, United States, 11776 | |
| United States, Ohio | |
| Clinical Trial Site | Recruiting |
| Toledo, Ohio, United States, 43623 | |
| United States, Washington | |
| Clinical Trial Site | Recruiting |
| Spokane, Washington, United States, 99204 | |
| Argentina | |
| Clinical Trial Site | Recruiting |
| Buenos Aires, Argentina, C14626ABP | |
| Australia, New South Wales | |
| Clinical Trial Site | Recruiting |
| Gosford, New South Wales, Australia, 2250 | |
| Clinical Trial Site | Recruiting |
| Westmead, New South Wales, Australia, 2145 | |
| Australia, South Australia | |
| Clinical Trial Site | Recruiting |
| Adelaide, South Australia, Australia, 5000 | |
| Australia, Victoria | |
| Clinical Trial Site | Recruiting |
| Ballarat Central, Victoria, Australia, 3355 | |
| Clinical Trial Site | Recruiting |
| Clayton, Victoria, Australia, 3168 | |
| Clinical Trial Site | Recruiting |
| Shepparton, Victoria, Australia, 3630 | |
| Australia, Western Australia | |
| Clinical Trial Site | Recruiting |
| Nedlands, Western Australia, Australia, 6009 | |
| Hong Kong | |
| Clinical Trial Site | Recruiting |
| Central, Hong Kong, 100176 | |
| Clinical Trial Site | Recruiting |
| Central, Hong Kong, 999077 | |
| Clinical Trial Site | Recruiting |
| Kowloon, Hong Kong, 999077 | |
| Korea, Republic of | |
| Clinical Trial Site | Recruiting |
| Suwon-si, Gyeonggi-do, Korea, Republic of, 16247 | |
| Clinical Trial Site | Recruiting |
| Busan, Korea, Republic of, 49201 | |
| Clinical Trial Site | Recruiting |
| Seoul, Korea, Republic of, 2841 | |
| Clinical Trial Site | Recruiting |
| Seoul, Korea, Republic of, 3722 | |
| Clinical Trial Site | Recruiting |
| Suwon, Korea, Republic of, 16499 | |
| Malaysia | |
| Clinical Trial Site | Recruiting |
| Kota Bharu, Kelantan, Malaysia, 16150 | |
| Clinical Trial Site | Recruiting |
| George Town, Penang, Malaysia, 10450 | |
| Clinical Trial Site | Recruiting |
| Ipoh, Perak, Malaysia, 30450 | |
| Clinical Trial Site | Recruiting |
| Putrajaya, Putramya, Malaysia, 62250 | |
| Clinical Trial Site | Recruiting |
| Kuching, Sarawak, Malaysia, 93586 | |
| Clinical Trial Site | Recruiting |
| Petaling Jaya, Selangor, Malaysia, 46050 | |
| Clinical Trial Site | Recruiting |
| Kuala Lumpur, WP, Malaysia, 59100 | |
| Taiwan | |
| Clinical Trial Site | Recruiting |
| Changhua, Taiwan, 500 | |
| Clinical Trial Site | Recruiting |
| Kaohsiung, Taiwan, 80756 | |
| Clinical Trial Site | Recruiting |
| Taichung, Taiwan, 433 | |
| Clinical Trial Site | Recruiting |
| Tainan City, Taiwan, 736 | |
| Clinical Trial Site | Recruiting |
| Taipei, Taiwan, 100 | |
| Thailand | |
| Clinical Trial Site | Recruiting |
| Bangkok, Thailand, 10300 | |
| Clinical Trial Site | Recruiting |
| Bangkok, Thailand, 10330 | |
| Clinical Trial Site | Recruiting |
| Bangkok, Thailand, 10700 | |
| Clinical Trial Site | Recruiting |
| Samut Sakhon, Thailand, 74120 | |
| Clinical Trial Site | Recruiting |
| Songkhla, Thailand, 90110 | |
Sponsors and Collaborators
Olema Pharmaceuticals, Inc.
Investigators
| Study Director: | Medical Director, MD | Olema Pharmaceuticals, Inc. |
Additional Information:
| Responsible Party: | Olema Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT06016738 |
| Other Study ID Numbers: |
OP-1250-301 OPERA-01 ( Other Identifier: Olema Pharmaceuticals, Inc. ) |
| First Posted: | August 30, 2023 Key Record Dates |
| Last Update Posted: | April 12, 2024 |
| Last Verified: | April 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Letrozole Fulvestrant Anastrozole Exemestane Antineoplastic Agents |
Aromatase Inhibitors Steroid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Estrogen Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Estrogen Receptor Antagonists |