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Clinical Trials List

Protocol NumberOP-1250-301
NCT Number(ClinicalTrials.gov Identfier)NCT06016738

2023-12-01 - 2027-12-31

Phase III

Recruiting9

ICD-10C50.911

Malignant neoplasm of unspecified site of right female breast

ICD-10C50.912

Malignant neoplasm of unspecified site of left female breast

ICD-10C50.919

Malignant neoplasm of unspecified site of unspecified female breast

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9174.9

Malignant neoplasm of female breast, unspecified

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)

  • Trial Applicant

  • Sponsor

    Olema Pharmaceuticals, Inc.

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/11/08

Investigators and Locations

Principal Investigator 戴明燊 Division of Hematology & Oncology
Tri-Service General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Liang-Chih Liu Division of General Surgery
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator YEN-SHEN LU Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 郭集慶 Division of Hematology & Oncology
Kuang Tien General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Ling-Ming Tseng Division of General Surgery
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 黃文聰 Division of Hematology & Oncology
Chi Mei Hospital, Liouying

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 陳守棟 Division of General Surgery
CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 賴泓誌 Division of Hematology & Oncology
Shin Kong Memorial Wu Ho-Su Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Ming-Feng Hou
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

ER-positive, HER2-negative advanced or metastatic breast cancer

Objectives

Primary Objective: • To evaluate the safety of OP-1250 at the 90 mg and 120 mg dose levels. Secondary Objectives: • To assess the objective response rate (ORR), duration of response (DoR), disease control rate (DCR), clinical benefit rate (CBR), and progression-free survival (PFS) of OP-1250 at the 90 mg and 120 mg dose levels, as determined by local investigator assessment. • To evaluate the pharmacokinetics (PK) of OP-1250 at the 90 mg and 120 mg dose levels. Exploratory Objective: • To evaluate changes in health-related patient-reported outcomes (PROs) from baseline.

Test Drug

OP-1250Fulvestrant Sandoz 250mg/5ml Solution for InejctionFulvestrant Lyophilized Injection 250mg "GBC"Anastrozole F.C. Tablets 1mg "Sinphar"Arbreast F.C. Tab. 1mg (Anastrozole)Aromatt 1 (An

Active Ingredient

OP-1250 Drug Substance
OP-1250 Drug Substance
FULVESTRANT
FULVESTRANT
ANASTROZOLE
ANASTROZOLE
ANASTROZOLE
LETROZOLE
LETROZOLE
EXEMESTANE
TRIPTORELIN ACETATE
TRIPTORELIN ACETATE
TRIPTORELIN

Dosage Form

film coated tablets
Solution for Inejction
Lyophilized Injection
film coated tablets
film coated tablets
film coated tablets
film coated tablets
film coated tablets
film coated tablets
Lyophi

Dosage

30 mg/tablet
60 mg/tablet
250mg/5ml
250mg
1 mg/tablet
1 mg/tablet
1 mg/tablet
2.5 mg/tablet
2.5 mg/tablet
25 mg/tablet
3.75 mg/vial
0.1 mg/vial
11.25 mg/vial
3.75 mg/vial
11.25 mg/vial

Endpoints

Safety and tolerability as assessed by adverse events (AEs), serious adverse events (SAEs), dose modifications, clinical laboratory parameters (i.e., hematology, chemistry, and coagulation), electrocardiograms (ECGs), and vital sign measurements.

Inclution 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.

Exclusion Criteria

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.

The Estimated Number of Participants

  • Taiwan

    45 participants

  • Global

    510 participants

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