QL1706 Plus Chemotherapy as Neoadjuvant Therapy in Early High-Risk ER+/HER2- 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 followed by AC/EC in a neoadjuvant setting, in high-risk, ER+/HER2- 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 ER+/HER2- breast cancer, histological grade II, Ki-67 ≥ 20% and TNM stage T1c-T2, cN1-cN2 or T3- 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
- QL1706 (bispecific antibody targeting PD-1 and CLTA-4)
- Albumin-bound paclitaxel
- Doxorubicin
- Cyclophosphamide
- Epirubicin
Treatment groups
76 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov