Recruitment of clinical research volunteers (breast cancer)

The Hong Kong United Oncology Centre is currently conducting an international Phase III clinical trial. If you are a patient with estrogen receptor-positive (ER+), HER2-negative (HER2−) advanced/metastatic breast cancer, please contact us. We will conduct an initial assessment to determine if you meet the eligibility criteria for this clinical trial. Medication and imaging scan costs are fully covered. However, patients must understand the purpose of the study and the potential risks involved.

Research name

OPERA-02 Study [A Phase 3, randomized, double-blind, active-controlled study of palazestrant plus ribociclib versus letrozole plus ribociclib as first-line treatment for ER+, HER2− advanced breast cancer]

OPERA-02 Study [A Phase 3 randomized, double-blind, active-controlled study of palazestrant with ribociclib versus letrozole with ribociclib for the first-line treatment of ER+, HER2– advanced breast cancer].

ClinicalTrials.gov Identifier:
NCT07085767 (See detailed study information)

Patient eligibility

• Pathologically/cytologically confirmed advanced/metastatic breast cancer that is ER-positive (≥1%) and HER2-negative, and is incurable.
  Histologically/cytologically confirmed ER+ (≥1%) and HER2− advanced/metastatic breast cancer, not amenable to curative therapy
• Newly diagnosed advanced breast cancer, or recurrence ≥12 months after completion of adjuvant endocrine therapy (± CDK4/6 inhibitor).
  De novo ABC or recurrence ≥12 months after completing adjuvant endocrine therapy (± CDK4/6i)

Research remuneration

• Related research drugs, designated tests/imaging, and outpatient consultations designated for research are all free of charge.
  Study-related drugs, specified assessments/imaging, and study-specified clinic visit fees are covered.

Research process

If you are eligible to participate in this study, you will be randomly assigned (1:1 ratio) to receive one of the following treatment regimens (double-blind, active-controlled, first-line):
If eligible, you will be randomized 1:1 (double‑blind, active‑controlled, first‑line) to one of the following regimens.

• Palazestrant 90 mg orally once daily (continuously; 28-day cycle); Ribociclib 600 mg orally once daily, days 1–21 (3 weeks on/1 week off); Letrozole-matched placebo once daily; for premenopausal/perimenopausal women and men: continuous GnRH/LHRH agonist starting ≥2 weeks before the first dose.
  Experimental arm: Palazestrant 90 mg PO QD (continuous; 28‑day cycles); Ribociclib 600 mg PO QD on Days 1–21 of each 28‑day cycle (3 weeks on/1 week off); Letrozole‑matching placebo PO QD; GnRH/LHRH agonist for pre/perimenopausal females and men, starting ≥2 weeks before first dose and continued.
• Letrozole 2.5 mg orally once daily (continuously); Ribociclib 600 mg orally once daily, Days 1–21; Palazestrant-matched placebo once daily; for premenopausal/perimenopausal women and men: continuous GnRH/LHRH agonist starting ≥2 weeks before the first dose.
  Comparator arm: Letrozole 2.5 mg PO QD (continuous); Ribociclib 600 mg PO QD on Days 1–21 of each 28‑day cycle; Palazestrant‑matching placebo PO QD; GnRH/LHRH agonist for pre/perimenopausal females and men, starting ≥2 weeks before first dose and continued.

Related risks

The study drug or procedure may cause mild to moderate discomfort, and the actual experience may vary from person to person; the research team will closely monitor and provide appropriate treatment. Further details can be found in the informed consent form and will be explained by the research physician.
Study drugs/procedures may cause mild-to-moderate discomfort. Actual experience varies. The study team will monitor closely and manage appropriately. Full details are in the informed consent and will be explained by the study physicians.

Contact method

Interested participants can contact us through the following methods for further understanding：

• WhatsApp：5518 2992
• Telephone：+852 2386 8002
• Email：Enquiry@hkuoc.hk
• WeChat: hkuoc23868002
• 

Related resources

Inquire about more research projects：Clinical Research Page of the United Cancer Centre of Hong Kong
Learn more about breast cancer：Hong Kong Hospital Authority-Breast Cancer Information

Research sponsor

Olema Pharmaceuticals, Inc.