NCT06404463

QL1706 Plus Chemotherapy as Neoadjuvant Therapy in Early High-Risk ER+/HER2- Breast Cancer

A Phase II Study of Neoadjuvant QL1706 Plus Chemotherapy in Participants With High-Risk ER+/HER2- Early-Stage Breast Cancer (QUEEN-Neo)

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 76 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This study is a single-arm, single-center, phase II clinical trial aimed at observing and evaluating the effectiveness and safety of QL1706 combined with albumin-bound paclitaxel, sequential AC (doxorubicin/cyclophosphamide) neoadjuvant therapy for early high-risk ER+/HER2- breast cancer. A total of 76 subjects are planned to be enrolled. After enrollment, subjects will receive QL1706 combined with albumin-bound paclitaxel for 4 cycles followed by sequential AC/EC treatment for 4 cycles. Each treatment cycle will span 3 weeks until the occurrence of a specified treatment termination event, after which subjects will continue to undergo postoperative efficacy and safety assessments. Safety assessments will be conducted before each QL1706 treatment cycle. Imaging evaluations will be performed every 2 cycles until completion of 8 cycles of treatment to assess efficacy. Additional imaging assessments may be performed as clinically indicated during the study. Tumor imaging assessments will continue until confirmed disease progression according to RECIST v1.1 criteria, initiation of new anti-tumor therapy, withdrawal of consent, or death, whichever occurs first. Following treatment completion, a treatment completion visit will be conducted. Subjects who discontinue treatment due to reasons other than RECIST v1.1-defined disease progression will undergo regular tumor imaging assessment follow-ups to evaluate time to disease progression. Subjects will also undergo survival follow-up visits every 6 months (every 3 months in the first year and every 6 months thereafter) after treatment completion to collect and record survival status and subsequent anti-tumor treatment information.

Conditions

• Early Breast Cancer
• Neoadjuvant Therapy
• HR+HER2- Breast Cancer

Interventions

Type	Name	Description
DRUG	QL1706 (bispecific antibody targeting PD-1 and CLTA-4)	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).
DRUG	Albumin-bound paclitaxel	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.
DRUG	Doxorubicin	Doxorubicin, a widely used chemotherapy drug, belongs to the anthracycline class and is effective against various cancers, including breast cancer, leukemia, and sarcomas. It works by intercalating with DNA and inhibiting topoisomerase II, leading to DNA damage and disruption of DNA replication and transcription processes within cancer cells. Despite its efficacy, doxorubicin may cause side effects such as cardiotoxicity and bone marrow suppression, limiting its long-term use in some patients.
DRUG	Cyclophosphamide	Cyclophosphamide is a chemotherapy medication commonly used to treat various types of cancers, including lymphoma, leukemia, and breast cancer. It belongs to the class of alkylating agents and works by crosslinking DNA strands, which prevents cell division and leads to cell death. While effective in treating cancer, cyclophosphamide can also cause side effects such as nausea, vomiting, and suppression of the immune system.
DRUG	Epirubicin	Epirubicin, a chemotherapy medication, is part of the anthracycline class and is used in the treatment of various cancers, including breast cancer, ovarian cancer, and soft tissue sarcoma. It functions by interfering with DNA replication and RNA synthesis within cancer cells, ultimately leading to cell death. Despite its efficacy, epirubicin can cause side effects such as nausea, hair loss, and bone marrow suppression.

Timeline

• Start date: 2024-05-06
• Primary completion: 2025-11-06
• Completion: 2030-11-06
• First posted: 2024-05-08
• Last updated: 2024-05-08