Breast CancerPhase 2NCT06088056
A Phase II Study of T-DXd Plus SRT in HER2-positive Breast Cancer Brain Metastases
A Phase 2 study testing Combination use of SRT with T-DXd in people with Breast Cancer and Brain Metastases, run by Fudan University at 1 site in China.
Trial summary
This research study will evaluate the efficacy and safety of stereotactic radiotherapy (SRT) combined with Trastuzumab-Deruxtecan (T-DXd; DS-8201a) in HER2-positive Breast Cancer Patients with newly diagnosed or progressing Brain Metastases. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Brain Metastases, Radiotherapy
- What is being tested?
- Combination use of SRT with T-DXd
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteChina
- Study dates
- Nov 2023to Jul 2026
- Phase
- Phase 2
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically confirmed HER2 positive advanced breast cancer
- Age>18 years.
- Brain metastases confirmed by enhanced brain MRI. Metastases number less than 15.
- KPS≥70 or KPS ≥60 with neurologic symptoms caused by BM
- Life expectancy of more than 6 months
- Prior therapy of oral dexamethasone not exceeding 16mg/d
Show all 15Show fewer
- Time interval from prior therapy was more than 2 weeks, and evaluation of adverse events is no more than grade 1.
- Screening laboratory values must meet the following criteria( and should be obtained within 28 days prior to registration):
- Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L, Platelets≥ 90 x 109/L, Hemoglobin ≥ 90 g/L
- Aspartate aminotransferase/alanine aminotransferase (AST/ALT) ≤2.5 x ULN without liver metastasis,≤ 5 x ULN with liver metastases
- Serum BUN and creatinine ≤ 1.5 x Upper Limit of Normal (ULN)
- LVEF ≥ 50%
- QTcF < 480 ms
- INR≤1.5×ULN，APTT≤1.5×ULN
- Signed the informed consent form prior to patient entry
Who cannot join
- Leptomeningeal or hemorrhagic metastases
- Uncontrolled epilepsy
- Severe or uncontrolled disease: severe cardiovascular disease, end-stage renal disease, severe hepatic disease, history of immunodeficiency, including HIV positive, active HBV/HCV or other acquired congenital immunodeficiency disease, or organ transplantation history, active infection, etc.
- History of allergy to treatment regimens
- Pregnancy or lactation period， women of child-bearing age who are unwilling to accept contraceptive measures.
- Inability to complete enhanced MRI
- Not suitable for inclusion for specific reasons judged by sponsor
Trial locations and contacts
1 site in 1 country.
China1 site
Fudan University Shanghai Cancer Center
Shanghai
Zhaozhi yang, PhD, +8618017317126, yzzhi2014@163.com
Jin Meng, PhD, +8618121299532, jinmeng@fudan.edu.cn
About this study
Official title: A Phase II Study of T-DXd Plus Stereotactic Radiotherapy(SRT) in HER2-positive Breast Cancer Brain Metastases
This research study will evaluate the efficacy and safety of stereotactic radiotherapy (SRT) combined with Trastuzumab-Deruxtecan (T-DXd; DS-8201a) in HER2-positive Breast Cancer Patients with newly diagnosed or progressing Brain Metastases.
- Conditions
- Breast Cancer, Brain Metastases, Radiotherapy
- Being tested
- Combination use of SRT with T-DXd
- Medical subject headings
- Breast Neoplasms, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination use of SRT with T-DXdDrug
Radiation therapy SRT will be implemented according to investigator's clinical practice(based on brain metastases number and tumor volume). T-DXd(5.4mg/kg, once per 21 days, initiated within 2 weeks after SRT) will be provided to patients with confirmed HER2 positive breast cancer and brain metastasis until tumor progression, a severe adverse event deemed related to the study drug, or death. All dose adjustments should be based on the most severe toxicity level (CTCAE version 5.0) that occurred. Two doses are allowed to be reduced.
Dose Level 0: 5.4mg/kg Dose Level 1 :4.4mg/kg Dose Level 2: 3.2mg/kg
| Study group | Role | What they receive |
|---|---|---|
| Combination use of SRT with T-DXd | Experimental | Radiation therapy SRT will be implemented according to investigator's clinical practice(based on brain metastases number and tumor volume). T-DXd(5.4mg/kg, once per 21 days, initiated within 2 weeks after SRT) will be provided to patients with confirmed HER2 positive breast cancer and brain metastasis until tumor progression, a severe adverse event deemed related to the study drug, or death. All dose adjustments should be based on the most severe toxicity level (CTCAE version 5.0) that occurred. Two doses are allowed to be reduced.
Dose Level 0: 5.4mg/kg Dose Level 1 :4.4mg/kg Dose Level 2: 3.2mg/kg Receives: Drug: Combination use of SRT with T-DXd |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intracranial objective response rate(IC-ORR)
Proportion of participants with a complete response (CR) or partial response (PR) for intracranial tumors as defined by response assessment in neuro-oncology brain metastases (RANO-BM) criteria.
Measured: 2 years
Secondary outcomes (7)
Intracranial CNS Progression Free Survival(IC-PFS)
Time from treatment until the first date of intracranial disease progression or death due any cause. For participants whose disease has not progressed at the time of the analysis, censoring will be performed using the date of the last valid disease assessment.
Measured: 2 years
Progression Free Survival(PFS)
Time from treatment until the first date of intracranial or extracranial disease progression or death due any cause. For participants whose disease has not progressed at the time of the analysis, censoring will be performed using the date of the last valid disease assessment.
Measured: 2 years
Overall survival(OS)
Time from the treatment until to the date of death, regardless of the cause of death
Measured: 3 years
Percentage of Participants With Adverse Events Percentage of Participants With Adverse Events
Treatment-related adverse events were assessed and graded according to CTCAE v. 5.0
Measured: 2 years
Health-related quality of life per FACT-BR
Health-related quality of life was evaluated using the QLQ-C30 questionnaires to assess Health-related quality of life was evaluated using the FACT-BR questionnaires to assess the quality of life
Measured: 2 years
Local control rate
The percentage of participants who have achieved complete response, partial response and stable disease according to RANO-BM criteria after treatment
Measured: 2 years
Neurocognitive function per HVLT-R
Neurocognitive function was evaluated using HVLT-R test
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study startNov 2023 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionJul 2026 (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.
- More trials run by Fudan UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaoli Yu, Fudan University
- Investigators
- Zhaozhi Yang, Principal investigator, Fudan UniversityJiayi Chen, Principal investigator, Ruijin Hospital affiliated to Shanghai Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06088056
- Sponsor's protocol ID
- FDRT-BC021
- Status last verified
- Oct 2023
- First submitted
- 30 Jul 2023
- Last updated
- 18 Oct 2023
- Results posted
- No
- 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 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of T-DXd Plus Stereotactic Radiotherapy(SRT) in HER2-positive Breast Cancer Brain Metastases
- ClinicalTrials.gov ID
- NCT06088056
- Acronym / sponsor ID
- FDRT-BC021
- Conditions
- Breast Cancer, Brain Metastases, Radiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 17 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Nov 2023 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 18 Oct 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.
This research study will evaluate the efficacy and safety of stereotactic radiotherapy (SRT) combined with Trastuzumab-Deruxtecan (T-DXd; DS-8201a) in HER2-positive Breast Cancer Patients with newly diagnosed or progressing Brain Metastases.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combination use of SRT with T-DXd | Experimental | Drug: Combination use of SRT with T-DXdRadiation therapy SRT will be implemented according to investigator's clinical practice(based on brain metastases number and tumor volume). T-DXd(5.4mg/kg, once per 21 days, initiated within 2 weeks after SRT) will be provided to patients with confirmed HER2 positive breast cancer and brain metastasis until tumor progression, a severe adverse event deemed related to the study drug, or death. All dose adjustments should be based on the most severe toxicity level (CTCAE version 5.0) that occurred. Two doses are allowed to be reduced. Dose Level 0: 5.4mg/kg Dose Level 1 :4.4mg/kg Dose Level 2: 3.2mg/kg |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Pathologically confirmed HER2 positive advanced breast cancer
- Age>18 years.
- Brain metastases confirmed by enhanced brain MRI. Metastases number less than 15.
- KPS≥70 or KPS ≥60 with neurologic symptoms caused by BM
- Life expectancy of more than 6 months
Key exclusion criteria (7 listed)
- Leptomeningeal or hemorrhagic metastases
- Uncontrolled epilepsy
- Severe or uncontrolled disease: severe cardiovascular disease, end-stage renal disease, severe hepatic disease, history of immunodeficiency, including HIV positive, active HBV/HCV or other acquired congenital immunodeficiency disease, or organ transplantation history, active infection, etc.
- History of allergy to treatment regimens
- Pregnancy or lactation period， women of child-bearing age who are unwilling to accept contraceptive measures.
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 |
|---|---|---|
| Combination use of SRT with T-DXdRadiation therapy SRT will be implemented according to investigator's clinical practice(based on brain metastases number and tumor volume). T-DXd(5.4mg/kg, once per 21 days, initiated within 2 weeks after SRT) will be provided to patients with confirmed HER2 positive breast cancer and brain metastasis until tumor progression, a severe adverse event deemed related to the study drug, or death. All dose adjustments should be based on the most severe toxicity level (CTCAE version 5.0) that occurred. Two doses are allowed to be reduced. Dose Level 0: 5.4mg/kg Dose Level 1 :4.4mg/kg Dose Level 2: 3.2mg/kg | Drug | Combination use of SRT with T-DXd |
Primary outcome
Intracranial objective response rate(IC-ORR)
Time frame: 2 years
Proportion of participants with a complete response (CR) or partial response (PR) for intracranial tumors as defined by response assessment in neuro-oncology brain metastases (RANO-BM) criteria.
7 secondary outcomes
Intracranial CNS Progression Free Survival(IC-PFS)
Time frame: 2 years
Progression Free Survival(PFS)
Time frame: 2 years
Overall survival(OS)
Time frame: 3 years
Percentage of Participants With Adverse Events Percentage of Participants With Adverse Events
Time frame: 2 years
Health-related quality of life per FACT-BR
Time frame: 2 years
Local control rate
Time frame: 2 years
Neurocognitive function per HVLT-R
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
- Individual participant dataSharing planned: No
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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.
Zhaozhi Yang principal investigator
Fudan University
Jiayi Chen principal investigator
Ruijin Hospital affiliated to Shanghai Jiaotong University
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 Combination use of SRT with T-DXd in people with Breast Cancer and Brain Metastases, run by Fudan University 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 15 inclusion and 7 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 Oct 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhaozhi Yang (+8618017317126, yzzhi2014@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intracranial objective response rate(IC-ORR) (time frame: 2 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 18 Oct 2023.