A Study of SKB264 Versus Investigator's Choice of Chemotherapy in Subjects With Unresectable Loca… (NCT07071337) | Clinical Trial Compass
RecruitingPhase 3
A Study of SKB264 Versus Investigator's Choice of Chemotherapy in Subjects With Unresectable Locally Advanced, Relapsed, or Metastatic HR+/HER2- Breast Cancer Who Have Previously Failed Endocrine Therapy
China430 participantsStarted 2025-07-18
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 have previously failed endocrine therapy.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Aged ≥ 18 and ≤ 75 years at the time of signing the ICF, male or female;
✓. Histologically and/or cytologically confirmed HR+/HER2- BC based on pathological reports from the most recent biopsy or other pathological specimens;
✓. Subjects must have radiologically documented disease progression during or after the most recent treatment prior to enrollment;
✓. No prior systemic chemotherapy for locally advanced, relapsed, or metastatic stages. Subjects who previously received adjuvant/neoadjuvant chemotherapy and progressed \>6 months after completion of the last chemotherapy treatment will be allowed for study inclusion;
✓. The investigator assessed that the patient could not continue to benefit from endocrine therapy and was suitable for receiving first-line chemotherapy;
✓. Able to provide recently newly obtained or archival tumor tissue sections at or after diagnosis of relapsed or metastatic tumor within the recent prior to randomization;
✓. At least one measurable lesion per RECIST v1.1；
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 with no worsening within 2 weeks prior to randomization;
Exclusion criteria
✕. Subjects with locally advanced breast cancer suitable for curative therapy at study enrollment;
✕. Other malignancies (except those tumors cured by local treatment, such as basal cell carcinoma of skin, squamous cell carcinoma of skin, carcinoma in situ of the cervix) within 3 years prior to randomization;
What they're measuring
1
Progression Free Survival (PFS) assessed by Blinded Independent Central Review (BICR)
Timeframe: Randomization up to approximately 24 months
✕. Subiects with known meningeal metastases, brainstem metastases, spinal cord metastases and/or compression or active centralnervous system (CNS) metastases.
✕. Presence of any serious cardiovascular and cerebrovascular diseases or cardiovascular and cerebrovascular risk factors;
✕. History of (noninfectious) interstitial lung disease (ILD)/noninfectious pneumonitis requiring steroid therapy and current ILD/noninfectious pneumonitis, or suspected ILD/noninfectious pneumonitis at screening that cannot be excluded by imaging;
✕. Clinically serious lung injuries caused by lung diseases;
✕. Serious infection within 4 weeks prior to randomization, including but not limited to complications requiring hospitalization, sepsis, or severe pneumonia; active infection requiring systemic anti-infective therapy within 2 weeks prior to randomization;
✕. Documented severe dry eye syndrome, severe meibomian gland dysfunction and/or blepharitis, or history of severe corneal disorders that prevent/delay corneal healing;