QL1706 Plus Chemotherapy as Neoadjuvant Therapy in Early High-Risk TNBC Breast Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorFudan University
About this trial
This study will look at the efficacy and safety of QL1706 plus albumin-bound paclitaxel and carboplatin in a neoadjuvant setting, in high-risk, TNBC early breast cancer.
Eligibility criteria
Qualifiers
Voluntarily join this study and sign the informed consent form;
Female patients aged ≥18 years and ≤70 years old who are newly diagnosed with breast cancer. According to the definition of the latest ASCO/CAP guidelines, histopathologically confirmed TNBC breast cancer, histological grade II, TNM stage T1cN1-cN2 or T2-T4, cN0-cN2;
According to RECIST 1.1, there is at least one measurable lesion;
ECOG score: 0~1;
Disqualifiers
The presence of any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism;
Those who suffer from vitiligo or whose asthma has been completely relieved in childhood and do not need any intervention in adulthood can be included; asthma that requires medical intervention with bronchodilators cannot be included);
Are currently using immunosuppressants or systemic hormone therapy to achieve immunosuppression (dose >10 mg/day prednisone or other effective hormones), and are still using it within 2 weeks before enrollment;
Severe allergic reactions to other monoclonal antibodies; Known history or evidence of interstitial lung disease or active non-infectious pneumonia;
Trial design
Treatments tested in this trial
- Bispecific antibody (bsAb) targeting PD-1 and CLTA-4
- Albumin-bound paclitaxel
- Carboplatin
Treatment groups
73 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov