Trastuzumab rezetecan with or without radiotherapy for HER2‑positive advanced breast cancer that has spread to the brain.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized Phase 2 trial plans to enroll 224 adults with HER2‑positive advanced breast cancer and at least one measurable, untreated intracranial lesion and will assign them 1:1 to receive trastuzumab rezetecan with radiotherapy (FSRT or WBRT) or trastuzumab rezetecan alone. Treatment continues until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. Key eligibility includes no prior cranial radiation, adequate organ function, life expectancy of at least six months, and no leptomeningeal disease. The study will compare intracranial tumor control and safety between the two groups.

Why it matters

Who can join: the full rules

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.

Where it's running

• Professor
  Zhengzhou, Henan, China Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Primary tumor removal with targeted lymph node removal plus radiation for biliary tract cancer with lymph node spread

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.