At a glance
ClinicalIndex Comparison Record- ✓Age 18 years or older
- ✓Invasive breast cancer with disease progression after anti-HER2 therapy (TKIs) for stage IV at diagnosis or within 1 year of adjuvant anti-HER2 therapy (HP) after early breast cancer surgery
- ✓At least one measurable lesion per RECIST 1.1
- ✓ECOG 0 or 1
- ✕Male breast cancer or inflammatory breast cancer
- ✕Other malignant tumors or history of malignancy other than breast cancer in past 5 years, except adequately treated basal cell carcinoma, squamous cell carcinoma, or cervical carcinoma in situ
- ✕Concurrent anti-tumor treatment or participation in other clinical trials
- ✕Prior use of ADC drugs
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
NCT06125834Phase 2RecruitingUpdate OverdueUpdated 26mo ago · Completion was 14mo agoTrastuzumab Emtansine (T-DM1) Treatment in HER2-positive Breast Cancer Patients With Progressive Disease After TKIs or HP Therapy: a Multicenter, Single-arm, Phase II Study
In Brief
A Phase 2 clinical trial evaluating Trastuzumab Emtansine (T-DM1) for Advanced Breast Cancer and 2 related conditions. Currently recruiting, targeting 36 participants across 1 site.
Signals
Detailed Summary
The goal of this clinical trial is to learn about the efficacy and safety of trastuzumab emtansine (T-DM1) in the treatment of patients with advanced HER2-positive breast cancer after TKIs or HP therapy. The main questions it aims to answer are: * The objective response rate of patients receiving T-DM1 therapy with advanced HER2-positive breast cancer after TKIs or HP therapy. * The adverse events and prognosis of patients with advanced HER2-positive breast cancer who receive the T-DM1 therapy. * Changes of anti-tumor immunity during T-DM1 therapy in patients with advanced HER2-positive breast cancer. Participants will receive T-DM1 treatment (3.6mg/kg, d1/21, IVD) until progressive diseases or intolerable adverse effects occurs.
Study Details
Timeline
Interventions
Enrolled patients will receive Trastuzumab Emtansine (T-DM1) treatment (3.6mg/kg, d1/21, IVD) until progressive diseases or intolerable adverse effects occurs.