QL1706 Plus Chemotherapy as Neoadjuvant Therapy in Early High-Risk TNBC Breast Cancer

ConditionsEarly Breast Cancer Neoadjuvant Therapy TNBC, Triple Negative 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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

Bispecific antibody (bsAb) targeting PD-1 and CLTA-4
Drug
QL1706 is a novel bispecific combination antibody composed of a recombinant humanized IgG4 monoclonal antibody targeting human PD-1 (programmed cell death protein 1) (PSB103) and a recombinant humanized IgG1 monoclonal antibody targeting human CTLA-4 (cytotoxic T-lymphocyte-associated protein 4) (PSB105). Both antibodies have undergone engineering modifications to introduce mutations facilitating their correct assembly and preventing mispairing, and are expressed in the same cell line at a predetermined ratio (approximately 2:1).
Albumin-bound paclitaxel
Drug
Albumin-bound paclitaxel improves the solubility and delivery of paclitaxel to tumor cells by binding to human albumin, facilitating its transportation through the bloodstream and enhancing its uptake into tumor tissue. It works by binding to and stabilizing microtubules within cancer cells, thereby disrupting the normal process of cell division and leading to cell cycle arrest and apoptosis, ultimately resulting in the death of cancer cells.
Carboplatin
Drug
Carboplatin is a chemotherapy medication belonging to the platinum-based class of drugs, commonly used in the treatment of various cancers, including ovarian cancer, lung cancer, and bladder cancer. It functions by forming DNA adducts, disrupting DNA replication and transcription processes in cancer cells, ultimately leading to cell death. Despite its efficacy, carboplatin can cause side effects such as nausea, vomiting, and bone marrow suppression.

Treatment groups

73 Participants

are divided into 1 treatment group

Group A: QL1706Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

Total Pathological complete response (tpCR) rate using the definition of ypT0/Tis, N0

No invasive residual in breast or nodes; noninvasive breast residuals allowed ) at the time of definitive surgery

Time frame