Breast CancerNCT06135194
Efficacy of T-Dxd in the Treatment of HER2-positive BCBM After Prior Pyrotinib
An observational study of Breast Cancer, run by Beijing 302 Hospital at 2 sites in China.
Trial summary
To evaluate the efficacy and safety of T-DXd in the treatment of HER2-positive breast cancer with brain metastases after treatment with pyrotinib Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- T-DXd
- How many people
- 30 participants
- Where
- 2 sitesChina
- Study dates
- 1 Apr 2021to 30 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with brain metastases from HER2 positive breast cancer after treatment with pyrotinib
Who may be able to join
- Women ≥18 years of age :(2) pathological diagnosis of HER2-positive breast cancer, defined as positive immunohistochemistry detection (+++) or FISH(Fluorescent In Situ Hybridization); (3) Imaging evidence of brain metastases; (4) Progression of brain metastases after prior treatment with pyrotinib, defined as progression of new or pre-existing brain metastases during treatment with pyrotinib; (5)ECOG score ≤3 points; (6) The efficacy of T-DXd should be evaluated at least once after treatment; (7) Bone marrow and organ functions are basically normal; (8) Complete medical records
Who cannot join
- Has uncontrolled or significant cardiovascular disease
- Has history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or suspected ILD/ pneumonitis that cannot be ruled out by imaging at screening
- Has any medical history or condition that per protocol or in the opinion of the investigator is inappropriate for the study
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
The Fifth Medical Center of PLA General Hospital
Beijing, Beijing Municipality, 100071
Tao Wang, 01066947250, wangtaotg@163.com
- Recruiting
The Fifth Medical Center of PLA General Hospital
Beijing, Beijing Municipality, 100071
Tao Wang, 01066947250, wangtao@163.com
About this study
Official title: Efficacy and Safety of T-Dxd in the Treatment of HER2-positive Breast Cancer With Brain Metastases After Prior Pyrotinib Treatment
To evaluate the efficacy and safety of T-DXd in the treatment of HER2-positive breast cancer with brain metastases after treatment with pyrotinib
- Conditions
- Breast Cancer
- Being tested
- T-DXd
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T-DXdDrug
Also called DS-8201
Efficacy and safety of T-DXd in the treatment of HER2-positive breast cancer with brain metastases after treatment with pyrotinib
What is being measured
The primary outcome is the main question the study is designed to answer.
Central neryous system Progression Free Survival，CNS-PFS
The interval from the start of treatment to the onset of disease progression or death from any cause in the intracranial lesions
Measured: 3years
Secondary outcomes (3)
Overall Response Rate (ORR)for intracranial and extracranial lesions
Percentage of patients with CompleteResponse (CR) and partial response (PartialResponse (PR)
Measured: 3years
Overall Clinical Benefit Rate (CBR) for intracranial and extracranial lesions
Percentage of patients with complete response, partial response, and StableDisease (SD)≥6 months
Measured: 3years
Overall survival (Oversall Survival, OS) and security
The interval between the start of treatment and death from any cause
Measured: 5years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start1 Apr 2021
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing 302 Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- tao wang, Study director, Beijing 302 Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06135194
- Sponsor's protocol ID
- DS8021-Brain metastases
- Status last verified
- Oct 2023
- First submitted
- 13 Nov 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of T-Dxd in the Treatment of HER2-positive Breast Cancer With Brain Metastases After Prior Pyrotinib Treatment
- ClinicalTrials.gov ID
- NCT06135194
- Acronym / sponsor ID
- DS8021-Brain metastases
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Beijing 302 HospitalUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 18 Nov 2023 (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.
To evaluate the efficacy and safety of T-DXd in the treatment of HER2-positive breast cancer with brain metastases after treatment with pyrotinib
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with brain metastases from HER2 positive breast cancer after treatment with pyrotinib
Key inclusion criteria (1 listed)
- Women ≥18 years of age :(2) pathological diagnosis of HER2-positive breast cancer, defined as positive immunohistochemistry detection (+++) or FISH(Fluorescent In Situ Hybridization); (3) Imaging evidence of brain metastases; (4) Progression of brain metastases after prior treatment with pyrotinib, defined as progression of new or pre-existing brain metastases during treatment with pyrotinib; (5)ECOG score ≤3 points; (6) The efficacy of T-DXd should be evaluated at least once after treatment; (7) Bone marrow and organ functions are basically normal; (8) Complete medical records
Key exclusion criteria (3 listed)
- Has uncontrolled or significant cardiovascular disease
- Has history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or suspected ILD/ pneumonitis that cannot be ruled out by imaging at screening
- Has any medical history or condition that per protocol or in the opinion of the investigator is inappropriate for the study
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 |
|---|---|---|
| T-DXdAlso: DS-8201Efficacy and safety of T-DXd in the treatment of HER2-positive breast cancer with brain metastases after treatment with pyrotinib | Drug | – |
Primary outcome
Central neryous system Progression Free Survival，CNS-PFS
Time frame: 3years
The interval from the start of treatment to the onset of disease progression or death from any cause in the intracranial lesions
3 secondary outcomes
Overall Response Rate (ORR)for intracranial and extracranial lesions
Time frame: 3years
Overall Clinical Benefit Rate (CBR) for intracranial and extracranial lesions
Time frame: 3years
Overall survival (Oversall Survival, OS) and security
Time frame: 5years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
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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. This study is not recruiting at the moment.
tao wang study director
Beijing 302 Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Beijing 302 Hospital at 2 sites 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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact jinmei zhou (010-66947250, jinzhu2714@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Central neryous system Progression Free Survival，CNS-PFS (time frame: 3years). 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 18 Nov 2023.