Study of SKB264 for Locally Advanced, Recurrent or Metastatic HR+/HER2- Breast Cancer (NCT06081959) | Clinical Trial Compass
RecruitingPhase 3
Study of SKB264 for Locally Advanced, Recurrent or Metastatic HR+/HER2- Breast Cancer
China376 participantsStarted 2023-10-31
Plain-language summary
The purpose of this study is to evaluate the efficacy and safety of SKB264 in patients with unresectable locally advanced, recurrent, or metastatic HR+/HER2- breast cancer.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* Males or females aged ≥ 18 to ≤ 75 years at the time of signing the ICF;
* Histologically and/or cytologically confirmed HR+/HER2- breast cancer based on pathology reports on recent biopsy specimens or other pathological samples;
* Patients who had failed at least one line of systemic chemotherapy in unresectable locally advanced, recurrent, or metastatic stage;
* Patients with at least one measurable lesion per RECIST 1.1 criteria; those with only skin or bone lesions cannot be included;
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1;
* Expected survival ≥ 12 weeks;
* Adequate organ and bone marrow function;
* Patients who are eligible for a chemotherapy regimen in the control group;
* Female patients of childbearing potential and male patients with partners of childbearing potential who use effective medical contraception from the time of signing the informed consent form until 6 months after the last dose;
* Patients who voluntarily participate in the study and sign the ICF, and able to comply with the visit and related procedures stipulated in the plan.
Exclusion Criteria:
* Patients with a history of central nervous system (CNS) metastases or current CNS metastasesï¼›
* Patients with other malignancies (except cured basal or squamous cell skin cancer or carcinoma in situ of the cervix) within 3 years prior to the first dose;
* Patients with any cardio cerebral Vascular disease or cardio cerebral vascular risk factors…
What they're measuring
1
Progression-free survival (PFS) assessed by BIRC per RECIST 1.1.