HER2-positive Advanced Breast CancerPhase 2NCT07100600
Trastuzumab Rezetecan Combined With Radiotherapy Versus Trastuzumab Rezetecan in the Treatment of HER2-positive Advanced Breast Cancer With Brain Metastases
A Phase 2 study testing Trastuzumab Rezetecan and FSRT or WBRT in people with HER2-positive Advanced Breast Cancer and Brain Metastases, run by Henan Cancer Hospital at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HER2-positive Advanced Breast Cancer, Brain Metastases, Radiotherapy
- What is being tested?
- Trastuzumab Rezetecan and FSRT or WBRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 1 siteChina
- Study dates
- 30 Aug 2025to 30 Dec 2032
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Subjects 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 subjects during pregnancy and lactation
- Any other conditions that researchers believe that patients are unsuitable for this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Professor
Zhengzhou, Henan
Min Yan professor, +86 15713857388, ym200678@126.com
About this study
Official title: An Open-label, Randomized, Controlled Trial of Trastuzumab Rezetecan Combined With Radiotherapy Versus Trastuzumab Rezetecan in the Treatment of HER2-positive Advanced Breast Cancer With Brain Metastases
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).
- Being tested
- Trastuzumab Rezetecan, FSRT or WBRT
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trastuzumab RezetecanDrug
Trastuzumab Rezetecan：4.8mg/kg Q3W
FSRT or WBRTRadiation
FSRT （8Gy/3-5 fx）or WBRT（30Gy/10fx）
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | Trastuzumab Rezetecan Receives: Drug: Trastuzumab Rezetecan |
| experimental group | Experimental | Trastuzumab Rezetecan combined with radiotherapy Receives: Drug: Trastuzumab Rezetecan; Radiation: FSRT or WBRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Measured: up to 1.5 years
Secondary outcomes (4)
CNS-ORR
Measured: 2 months
ORR by investigator using RECIST Guideline
Measured: 2 months
CNS-PFS
Measured: 1.5 year
Adverse events
Measured: up to 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start30 Aug 2025
- Primary completion30 Jul 2030 (estimated)
- Study completion30 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-positive Advanced Breast CancerStudies of the same condition, open and under way.
- More trials run by Henan Cancer HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 224 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Min Yan, MD, Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07100600
- Sponsor's protocol ID
- 2025-408-001
- Status last verified
- Oct 2026
- First submitted
- 27 Jul 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Controlled Trial of Trastuzumab Rezetecan Combined With Radiotherapy Versus Trastuzumab Rezetecan in the Treatment of HER2-positive Advanced Breast Cancer With Brain Metastases
- ClinicalTrials.gov ID
- NCT07100600
- Acronym / sponsor ID
- 2025-408-001
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 224 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- 30 Aug 2025 (actual)
- Primary completion
- 30 Jul 2030 (estimated)
- Study completion
- 30 Dec 2032 (estimated)
- First posted
- 3 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Drug: Trastuzumab RezetecanTrastuzumab Rezetecan |
| experimental group | Experimental | Drug: Trastuzumab Rezetecan, Radiation: FSRT or WBRTTrastuzumab Rezetecan combined with radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- Subjects 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；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trastuzumab RezetecanTrastuzumab Rezetecan：4.8mg/kg Q3W | Drug | control group, experimental group |
| FSRT or WBRTFSRT （8Gy/3-5 fx）or WBRT（30Gy/10fx） | Radiation | experimental group |
Primary outcome
PFS
Time frame: up to 1.5 years
4 secondary outcomes
CNS-ORR
Time frame: 2 months
ORR by investigator using RECIST Guideline
Time frame: 2 months
CNS-PFS
Time frame: 1.5 year
Adverse events
Time frame: up to 1.5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for HER2-positive Advanced Breast Cancer
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 1
HER2 Vaccine for Locally Advanced Breast Cancer
Breast Cancer, HER2-positive Breast Cancer
Not yet recruitingPhase 1
A Study to Evaluate the Effects of GDC-4198 in Combination With Letrozole, Fulvestrant, or Giredestrant in Participants With Locally Advanced or Metastatic Hormone Receptor-Positive, HER2-Negatve Breast Cancer
Advanced or Metastatic Breast Cancer
RecruitingObservational study
A Study to Evaluate the Effectiveness and Safety of Inavolisib in Participants With Endocrine-resistant, PIK3CA-mutated, Hormone Receptor-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer
Locally Advanced Breast Cancer, Metastatic Breast Cancer
RecruitingPhase 3
Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancer
PIK3CA Mutation, HER2- Negative Breast Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Trastuzumab Rezetecan and FSRT or WBRT in people with HER2-positive Advanced Breast Cancer and Brain Metastases, run by Henan Cancer Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: up to 1.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.