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

Henan Cancer Hospital

Status and phase: Enrolling; Phase 2

Conditions: Brain Metastases; HER2-positive Advanced Breast Cancer; Radiotherapy

Treatments: Drug: Trastuzumab Rezetecan; Radiation: FSRT or WBRT

Study type: Interventional

Funder types: Other

Identifiers

NCT07100600

2025-408-001

Details and patient eligibility

About

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).

Enrollment: 224 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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224 participants in 2 patient groups

control group

Active Comparator group

Description:

Trastuzumab Rezetecan

Treatment:

Drug: Trastuzumab Rezetecan

experimental group

Experimental group

Description:

Trastuzumab Rezetecan combined with radiotherapy

Treatment:

Radiation: FSRT or WBRT

Drug: Trastuzumab Rezetecan