Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07150208
PHASE2

T-DXd With or Without Bevacizumab for HER2-low Breast Cancer With Brain Metastasis

Sponsor: Fudan University

View on ClinicalTrials.gov

Summary

A phase II, open-label, multicenter, randomized controlled trial exploring the efficacy and safety of Trastuzumab Deruxtecan combined with or without Bevicizumab in HER2-low breast cancer with brain metastasis.

Official title: Trastuzumab Deruxtecan With or Without Bevacizumab for HER2-low Unresectable and/or Metastatic Breast Cancer With Brain Metastasis: A Multicenter, Randomized, Open Label, Phase II Trial (THUMB Trial)

Key Details

Gender

FEMALE

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

140

Start Date

2025-09

Completion Date

2028-09

Last Updated

2025-09-02

Healthy Volunteers

No

Interventions

DRUG

Bevacizumab (Bev)

Bevacizumab is a drug that targets vascular endothelial growth factor (VEGF) and inhibits tumor angiogenesis, thereby inhibiting tumor growth and spread. In the treatment of breast cancer, Bevacizumab can be used in combination with chemotherapy to improve treatment outcomes and extend patients' progression-free survival and overall survival.

DRUG

Trastuzumab Deruxtecan (T-DXd)

Trastuzumab deruxtecan (T-DXd) is an antibody-drug conjugate (ADC) composed of an anti-HER2 monoclonal antibody (trastuzumab), a cleavable linker, and a topoisomerase I inhibitor (an exatecan derivative). It targets and binds to HER2-positive tumor cells, internalizes, and releases cytotoxic drugs to induce DNA damage and apoptosis. It also has a "bystander effect" that can kill neighboring tumor cells with low HER2 expression, enhancing anti-tumor activity. T-DXd has shown significant efficacy in HER2-positive advanced breast cancer, with key clinical trials (such as DESTINY-Breast03) confirming that its progression-free survival (PFS) and overall survival (OS) are superior to traditional second-line treatments, with a median PFS reaching 28.8 months. Additionally, for HER2-low-expressing (IHC 1+ or 2+/ISH-) metastatic breast cancer (in the DESTINY-Breast04 study), T-DXd can extend PFS and OS, becoming the first targeted therapy to alter the survival outcomes of such patients.

Locations (1)

Fudan University Shanghai Cancer Center

Shanghai, China