QL1706 With Olaparib for Previously Treated HER2-negative Breast Cancer Patients With Homologous … (NCT07113964) | Clinical Trial Compass
Not Yet RecruitingPhase 2
QL1706 With Olaparib for Previously Treated HER2-negative Breast Cancer Patients With Homologous Recombination Deficiency (HRD)
China79 participantsStarted 2025-08-30
Plain-language summary
This study will evaluate the safety and efficacy of QL1706 and Olaparib in human epidermal growth factor receptor 2 (HER2)-negative unresectable and/or metastatic breast cancer who had received 2-4 line of prior systematic therapy.
Who can participate
Age range18 Years – 75 Years
SexFEMALE
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Inclusion criteria
✓. Age 18 - 75 years; Eastern Cooperative Oncology Group (ECOG) score status 0-1.
✓. Pathologically documented HER2-negative locally advanced or metastatic breast cancer (IHC0, IHC 1+\& IHC 2+/ISH-) that was hormone-receptor positive (i.e., estrogen-receptor positive, progesterone-receptor positive, or both) or was triple negative.
✓. Has been treated with 2-4 previous therapy regimens for metastatic disease.
✓. HRD positive confirmed, known germline and/or systemic BRCA mutation status that is predicted to be deleterious or suspected deleterious allow preferential enrolment.
✓. At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors version 1.1.
✓. Has protocol-defined adequate bone marrow, renal, hepatic and blood clotting functions.
✓. A life expectancy of at least 12 weeks.
✓. Female subjects of reproductive/childbearing potential must agree to use a highly effective form of contraception or avoid intercourse during and upon completion of the study and after the last dose for at least 3 months. Negative serum or urine pregnancy test within 7 days before study enrollment, and must be a non-lactating subject.
Exclusion criteria
✕. Has any active autoimmune disease, which may worsen when receiving immune stimulants.
✕. Prior treatment with immune checkpoint inhibitors (ICI) (anti-CTLA-4, anti-PD-1, anti-PD-L1, combined therapy anti-PD-1/PD-L1 with anti-CTLA-4) or olaparib for advanced disease.
What they're measuring
1
Progression-free Survival (PFS)
Timeframe: Up to approximately 3 years
Trial details
NCT IDNCT07113964
SponsorThe First Affiliated Hospital with Nanjing Medical University