MedTrace Logo

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

NCT06404463 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2024-05-08

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Principal Investigators

  • Zhimin Shao, MD,PhD · Breast cancer institute of Fudan University Cancer Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-06
Primary Completion
2025-11-06
Completion
2030-11-06

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06404463 on ClinicalTrials.gov