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

ConditionsBreast Cancer With Brain MetastasisHER2-low Expressing Breast Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorFudan University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

ECOG score of 0 to 1.

Expected survival period greater than 12 weeks.

Histologically confirmed invasive HER2-low expressing breast cancer (specific definition: breast cancer patients with low expression of human epidermal growth factor receptor 2 (HER-2) as determined by pathological testing. Specifically: HER2 IHC 1+ or HER2 IHC++ with FISH/CISH negative. All specimens must be verified by the pathology department of the research participating center.

Tumor stage: recurrent or metastatic breast cancer; local recurrence must be confirmed by the researcher to be unable to undergo radical surgical resection.

Disqualifiers

Received more than 2 lines of chemotherapy.

Used T-DXd or bevacizumab.

Meningeal metastasis.

Brain metastasis requiring emergency intervention treatment, or brain metastasis requiring treatment with more than 3mg/d of dexamethasone or equivalent medication.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Bevacizumab (Bev)

    Drug

    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.

  • Trastuzumab Deruxtecan (T-DXd)

    Drug

    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.

Treatment groups

140 Participants
are divided into 2 treatment groups
Group A: T-DXdActive comparator 1 intervention
Group B: T-DXd+BevacizumabExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Progression Free Survival(PFS)

Time to progressive disease (according to RECIST1.1)

Time frame
12 months

Secondary outcomes

1

CNS Progression-free survival (CNS-PFS)

Time from enrollment to the first radiographic documented disease progression (PD) of all CNS target lesions (RANO-BM criteria) or death from any cause without progression was recorded.

Time frame
12 months
2

Objective response rate (ORR)

Partial response is defined as a decrease by 30% or more in sums of longest diameter of measurable target lesions

Time frame
12 months
3

CNS Objective response rate (CNS-ORR)

The proportion of patients with complete response (CR) and partial response (PR) evaluated as the best response observed from enrollment to progression of all CNS target lesions assessed according to RANO-BM criteria among the total number of patients who could be evaluated.

Time frame
12 months
4

Overall survival (OS)

Time from the enrollment to death of any cause

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fudan University

Lead sponsor

Source ClinicalTrials.gov
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