CClinicalTrials.gg
Sign In
RecruitingNCT07100600Updated Aug 11, 2025

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

A Phase 2 interventional study of Trastuzumab Rezetecan and FSRT or WBRT in HER2-positive Advanced Breast Cancer, Brain Metastases and Radiotherapy, sponsored by Henan Cancer Hospital. Recruiting at 1 site in China. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-11.

Sponsored by Henan Cancer Hospital · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
224
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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 progression, intolerable toxicity, withdrawal of informed consent, or the study determines that treatment must be terminated (whichever occurs first).

02

Conditions studied

  • HER2-positive Advanced Breast Cancer
  • Brain Metastases
  • Radiotherapy

Browse trials for

03

In context

Brain Neoplasms

1,960 studies on the registry are indexed under Brain Neoplasms; 516 are open to participants now.

This study's planned enrollment of 224 is above the median of 40 across 1,458 interventional studies indexed under Brain Neoplasms.

Browse Brain Neoplasms studies →

Lead sponsor

Henan Cancer Hospital is the lead sponsor of 228 studies on the registry; 130 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
224 participants (estimated)

Study arms

  • Active comparator
    control group

    Trastuzumab Rezetecan

    Drug: Trastuzumab Rezetecan

  • Experimental
    experimental group

    Trastuzumab Rezetecan combined with radiotherapy

    Drug: Trastuzumab Rezetecan · Radiation: FSRT or WBRT

Interventions

  • DrugTrastuzumab Rezetecan

    Trastuzumab Rezetecan：4.8mg/kg Q3W

  • RadiationFSRT or WBRT

    FSRT （8Gy/3-5 fx）or WBRT（30Gy/10fx）

06

What researchers measure

Primary outcomes

  1. PFS

    Time frame: up to 1.5 years

Secondary outcomes

  1. CNS-ORR

    Time frame: 2 months

  2. ORR by investigator using RECIST Guideline

    Time frame: 2 months

  3. CNS-PFS

    Time frame: 1.5 year

  4. Adverse events

    Time frame: up to 1.5 years

07

Study locations

1 of 1 sites recruiting
  • Professor
    Zhengzhou, Henan, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 11, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07100600
Lead sponsor
Henan Cancer Hospital
Responsible party
Min Yan, MD (Chief Physician, Henan Cancer Hospital) — Principal investigator
First posted
Aug 3, 2025
Start date
Aug 30, 2025 (estimated)
Primary completion
Jul 30, 2030 (estimated)
Completion
Dec 30, 2032 (estimated)
Last update
Aug 11, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Brain Neoplasms→

Other studies from this sponsor

Henan Cancer Hospital

Start the discussion