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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06016738




Registration number
NCT06016738
Ethics application status
Date submitted
17/08/2023
Date registered
30/08/2023
Date last updated
8/10/2024

Titles & IDs
Public title
OP-1250 (Palazestrant) vs. Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer
Scientific 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)
Secondary ID [1] 0 0
OPERA-01
Secondary ID [2] 0 0
OP-1250-301
Universal Trial Number (UTN)
Trial acronym
OPERA-01
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Advanced Breast Cancer 0 0
Metastatic Breast Cancer 0 0
ER Positive Breast Cancer 0 0
HER2 Negative Breast Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Palazestrant
Treatment: Drugs - Fulvestrant
Treatment: Drugs - Anastrozole
Treatment: Drugs - Letrozole
Treatment: Drugs - Exemestane

Experimental: Palazestrant (OP-1250) - Participants will receive Palazestrant

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)


Treatment: Drugs: 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.

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

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

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

Treatment: Drugs: Exemestane
Participants will be treated with exemestane once daily on a 4 week (28 day) cycle
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Dose-Selection Part: Incidence of adverse events
Timepoint [1] 0 0
From Date of Randomization up to 16 weeks
Primary outcome [2] 0 0
Dose-Selection Part: Incidence of dose reduction
Timepoint [2] 0 0
From Date of Randomization up to 16 weeks
Primary outcome [3] 0 0
Dose-Selection Part: Incidence of drug discontinuation
Timepoint [3] 0 0
From Date of Randomization up to 16 weeks
Primary outcome [4] 0 0
Trial: Progression-Free Survival (PFS)
Timepoint [4] 0 0
From Date of Randomization until Disease Progression or Death Due to Any Cause (estimated as up to 2 years)
Secondary outcome [1] 0 0
Trial: Overall Survival (OS)
Timepoint [1] 0 0
From Date of Randomization until Death Due to Any Cause (estimated as up to 4 years)

Eligibility
Key inclusion 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
16/11/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/09/2027
Actual
Sample size
Target
510
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
Clinical Trial Site - Gosford
Recruitment hospital [2] 0 0
Clinical Trial Site - Westmead
Recruitment hospital [3] 0 0
Clinical Trial Site - Adelaide
Recruitment hospital [4] 0 0
Clinical Trial Site - Ballarat Central
Recruitment hospital [5] 0 0
Clinical Trial Site - Clayton
Recruitment hospital [6] 0 0
Clinical Trial Site - Shepparton
Recruitment hospital [7] 0 0
Clinical Trial Site - Nedlands
Recruitment postcode(s) [1] 0 0
2250 - Gosford
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
3355 - Ballarat Central
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3168 - Clayton
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3630 - Shepparton
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6009 - Nedlands
Recruitment outside Australia
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United Kingdom
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London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Olema Pharmaceuticals, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT06016738
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director, MD
Address 0 0
Olema Pharmaceuticals, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Olema Pharmaceuticals, Inc.
Address 0 0
Country 0 0
Phone 0 0
415-651-7206
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06016738