Trastuzumab Rezetecan Combined With Radiotherapy Versus Trastuzumab Rezetecan in the Treatment of HER2-positive Advanced Breast Cancer With Brain Metastases

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Trastuzumab Rezetecan Combined With Radiotherapy Versus Trastuzumab Rezetecan in the Treatment of HER2-positive Advanced Breast Cancer With Brain Metastases

Study Purpose

A total of 224 subjects of HER2-positive advanced breast cancer with brain metastases are planned to be enrolled. Eligible subjects will be randomly assigned in a 1:1 ratio to the group receiving Trastuzumab Rezetecan combined with radiotherapy or the group receiving Trastuzumab Rezetecan monotherapy until disease progression, intolerable toxicity, withdrawal of informed consent, or the study determines that treatment must be terminated (whichever occurs first).

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	Female

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Females ≥18 yrs old; 2. Pathologically confirmed HER2-positive advanced breast cancer; 3. At least one measurable intracranial lesion according to RANO-BM criteria, which had not received local treatment; 4. Without prior cranial radiation and had no indication for immediate local treatment or refuse to local treatment; 5. Life expectancy is not less than 6 months. 6. Adequate function of major organs.

Exclusion Criteria:

1. Subjects with leptomeningeal metastasis. 2. CNS complications requiring emergency neurosurgical intervention. 3. Previous treatment with trastuzumab deruxtecan (DS-8201a) or any other antibody drug conjugate (ADC) which consists of an exatecan derivative that is a topoisomerase 1 inhibitor; 4. Suffering from heart disease that is not well controlled or having clinical symptoms. 5. History of clinically significant lung disease； 6. Other malignant tumors, excluding cured cervical carcinoma in situ, skin basal cell carcinoma or skin squamous cell carcinoma, have been diagnosed in the past five years. 7. Female subjects during pregnancy and lactation. 8. Any other conditions that researchers believe that patients are unsuitable for this study.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT07100600
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Henan Cancer Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	HER2-positive Advanced Breast Cancer, Brain Metastases, Radiotherapy

Arms & Interventions

Arms

Active Comparator: control group

Trastuzumab Rezetecan

Experimental: experimental group

Trastuzumab Rezetecan combined with radiotherapy

Interventions

Drug: - Trastuzumab Rezetecan

Trastuzumab Rezetecan：4.8mg/kg Q3W

Radiation: - FSRT or WBRT

FSRT （8Gy/3-5 fx）or WBRT（30Gy/10fx）

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