SKB264 Plus Inetetamab in HER2-Positive Metastatic Breast Cancer Patients Progressing After T-DXd Treatment
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorFudan University
About this trial
This is a prospective, single-arm, single-center, Phase II clinical study designed to assess the preliminary efficacy and safety of SKB264 Plus Inetetamab plus inetetamab for the treatment of HER2-positive, unresectable, locally advanced or metastatic breast cancer following progression on prior T-DXd therapy.
Eligibility criteria
Qualifiers
Age ≥ 18 years, male or female.
Unresectable locally advanced or metastatic breast cancer.
Pathologically confirmed HER2-positive breast cancer, regardless of hormone receptor (HR) status. HER2 positivity is defined as: IHC 3+, or IHC 2+ and FISH positive.
Prior treatment for unresectable locally advanced or metastatic disease must have included the following anti-HER2 therapies: trastuzumab deruxtecan (T-DXd) and trastuzumab (or a trastuzumab biosimilar). Patients who received T-DXd and trastuzumab (or a biosimilar) in the (neo)adjuvant setting and experienced recurrence or metastasis during or within 12 months of completing therapy are eligible. Additionally, prior treatment regimens must have included a taxane.
Disqualifiers
Meningeal metastases confirmed by MRI or lumbar puncture.
Presence of spinal cord compression or clinically active central nervous system (CNS) metastases (defined as untreated or symptomatic metastases, or those requiring corticosteroids or anticonvulsants to control associated symptoms). Patients with previously treated brain metastases may be enrolled, provided they are clinically stable for at least 4 weeks, have no imaging evidence of progression, and at least 2 weeks have passed since the completion of brain radiotherapy and the discontinuation of corticosteroids or anticonvulsants for this indication.
Presence of third-space fluid accumulation (e.g., significant pleural effusion) that cannot be controlled by drainage or other methods.
Prior treatment with inetetamab or any TROP-2 antibody-drug conjugate (ADC).
Trial design
Treatments tested in this trial
- SKB264 Plus Inetetamab
Treatment groups
48 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov