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Compares treatment options for HER2-positive Advanced Breast Cancer
Official title Trastuzumab Rezetecan Combined With Radiotherapy Versus Trastuzumab Rezetecan in the Treatment of HER2-positive Advanced Breast Cancer With Brain Metastases
ClinicalTrials.gov ID: NCT07100600
What this study is testing
What is Trastuzumab Rezetecan?
Trastuzumab Rezetecan is an investigational medicine, being studied as a potential treatment for her2-positive advanced breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Females ≥18 yrs old;
- Pathologically confirmed HER2-positive advanced breast cancer;
- At least one measurable intracranial lesion according to RANO-BM criteria, which had not received local treatment;
- Without prior cranial radiation and had no indication for immediate local treatment or refuse to local treatment;
- Life expectancy is not less than 6 months.
You likely can't join if
- people with leptomeningeal metastasis
- CNS complications requiring emergency neurosurgical intervention
- Previous treatment with trastuzumab deruxtecan (DS-8201a) or any other antibody drug conjugate (ADC) which consists of an exatecan derivative that is...
- Suffering from heart disease that is not well controlled or having clinical symptoms
- History of clinically significant lung disease；
- Other malignant tumors, excluding cured cervical carcinoma in situ, skin basal cell carcinoma or skin squamous cell carcinoma, have been diagnosed in...
See the full eligibility criteria
- Females ≥18 yrs old;
- Pathologically confirmed HER2-positive advanced breast cancer;
- At least one measurable intracranial lesion according to RANO-BM criteria, which had not received local treatment;
- Without prior cranial radiation and had no indication for immediate local treatment or refuse to local treatment;
- Life expectancy is not less than 6 months.
- Adequate function of major organs.
- people with leptomeningeal metastasis
- CNS complications requiring emergency neurosurgical intervention
- 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;
- Suffering from heart disease that is not well controlled or having clinical symptoms
- History of clinically significant lung disease；
- 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.
- Female people during pregnancy and lactation
- Any other conditions that researchers believe that patients are unsuitable for this study.
The study team makes the final eligibility decision.
Where it's taking place
- Zhengzhou, Henan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Zhengzhou, Henan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.