Breast CancerPhase 1/2INOVATENCT07134153
Phase I/II Study of Intrathecal/Ommaya T-DXd in HER2-Expressing Breast Cancer With Leptomeningeal/Brain Metastases
A Phase 1/2 study testing T-DXd in people with Breast Cancer, run by Fudan University at 2 sites in China.
Trial summary
Multiple trials confirm systemic T-DXd efficacy in HER2+ breast cancer with leptomeningeal/brain metastases, yet median LM survival remains 3-4 months, highlighting unmet needs. While systemic therapies improve survival, intracranial disease control remains limited due to poor BBB penetration. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- T-DXd
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 2 sitesChina
- Study dates
- 12 May 2025to 28 Jun 2027
- Phase
- Phase 1/2
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years, regardless of gender.
- HER2-expressing advanced or metastatic breast cancer
- Leptomeningeal metastasis
- Subjects with active brain metastases only must have at least one intracranially measurable lesion (RANO-BM criteria).
- Adequate organ and bone marrow function
- No radiotherapy, chemotherapy, targeted therapy, immunotherapy, endocrine therapy, or surgery within 2 weeks prior to enrollment (or within 5 half-lives of prior therapy, whichever is shorter).
- All prior treatment-related toxicities must have resolved to ≤Grade 1
Who cannot join
- Diagnosis of other malignancies within the past 5 years, except for cured carcinoma in situ of the cervix, basal cell carcinoma or squamous cell carcinoma of the skin, other in situ carcinomas, or papillary thyroid carcinoma.
- Uncontrolled concurrent illnesses including, but not limited to: persistent or active infections, uncontrolled or clinically significant cardiovascular diseases, severe chronic gastrointestinal disorders with diarrhea, or psychiatric/social conditions that may compromise compliance with study requirements, significantly increase AE risks, or impair the subject's ability to provide written informed consent.
- History of (non-infectious) ILD/non-infectious pneumonitis requiring steroid therapy, current ILD/non-infectious pneumonitis, or suspected ILD/non-infectious pneumonitis that cannot be ruled out by imaging during screening.
- Clinically significant pulmonary comorbidities
- Use of immunosuppressants or systemic corticosteroids (>10 mg/day prednisone equivalent) for immunosuppression within 2 weeks prior to first dose (excluding intranasal/inhaled corticosteroids).
- Any active autoimmune disease or history of autoimmune disease with potential recurrence.
Show all 11Show fewer
- Uncontrolled infections requiring IV antibiotics, antivirals, or antifungals.
- Active primary immunodeficiency, known HIV infection, active HBV (HBsAg+ with HBV DNA ≥500 IU/mL) or HCV infection. HCV antibody-positive subjects are eligible only if PCR confirms HCV RNA negativity.
- Radiographic evidence of tumor encasement/invasion of major blood vessels, or investigator-determined high risk of fatal hemorrhage due to probable vascular invasion during treatment.
- Pregnant/lactating women, or subjects of reproductive potential unwilling/unable to use effective contraception.
- Any other condition deemed by investigators to potentially affect trial conduct or outcome interpretation.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Jian Zhang, MD,PhD, +8664175590 ext. 85000, syner2000@163.com
- Recruiting
Fudan University Shanghai Cancer Cancer
Shanghai, Shanghai Municipality, 200043
Jian Zhang, MD,PHD, +8664175590 ext. 85000, syner2000@163.com
Yanchun Meng, MD, +8664175590 ext. 63028, ycmclinicaltrials@126.com
About this study
Official title: Evaluating Safety and Efficacy of INtrathecal or Ommaya ReserVoir Administration of T-DXd in Patients With HER2-Expressing Breast Cancer With Active Leptomeningeal and/or Brain Metastases Based on Systemic Therapy: Phase I/II Study
Multiple trials confirm systemic T-DXd efficacy in HER2+ breast cancer with leptomeningeal/brain metastases, yet median LM survival remains 3-4 months, highlighting unmet needs. While systemic therapies improve survival, intracranial disease control remains limited due to poor BBB penetration. Preclinical data show no detectable T-DXd/DXd in CSF, though intrathecal trastuzumab demonstrates preliminary safety/efficacy in HER2+ LM.
This study evaluates intrathecal/intra-Ommaya T-DXd plus systemic therapy in active HER2+ meningeal/brain metastases, assessing safety, intracranial efficacy, and CSF/peripheral blood T-DXd distribution to clarify BBB penetration potential. Findings may guide novel therapeutic strategies for this high-need population.
Read the detailed description
Multiple clinical trials have demonstrated the efficacy of systemic T-DXd in advanced HER2-expressing breast cancer with leptomeningeal and/or brain metastases. However, the median survival of leptomeningeal metastasis (LM) patients remains only 3-4 months, and treatment options for isolated brain metastases are limited, underscoring the need for more effective therapeutic strategies.
While systemic therapies have prolonged survival in advanced breast cancer, intracranial disease management remains constrained by a lack of effective local treatments. As the use of T-DXd increases, the progression of intracranial lesions in patients who have received prior local therapy or lack indications for radiotherapy has become a critical unmet clinical challenge.
Conventional understanding holds that large biologic molecules poorly penetrate the blood-brain barrier (BBB). Preclinical studies detected neither T-DXd nor free DXd (payload) in cerebrospinal fluid (CSF), and the distribution of T-DXd in human CSF remains uncharacterized. However, preliminary data suggest that intrathecal trastuzumab-alone or combined with pertuzumab-exhibits acceptable safety and efficacy in HER2-positive LM.
Correction Notice: The Study Start Date was initially listed as April 18, 2025 (the date of Ethics Committee approval). It has been corrected to May 12, 2025, which is the actual date of first participant enrollment.
- 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 DS8201a
Evaluating safety and efficacy of intrathecal or ommaya reservoir administration of T-DXd in patients with HER2-expressing breast cancer with active leptomeningeal and/or brain metastases based on systemic therapy
| Study group | Role | What they receive |
|---|---|---|
| Phase I/Arm A(Intrathecal Dose-Escalation Phase) | Experimental | Population : T-DXd-naïve subjects with leptomeningeal metastases (LM), with or without concurrent brain metastases (BM).
Cycle 1 : Intrathecal (IT) T-DXd monotherapy to assess cerebrospinal fluid (CSF) and systemic pharmacokinetics (PK).
Cycles 2+ : IT T-DXd combined with intravenous (IV) T-DXd in a dose-escalation design to determine the maximum tolerated dose (MTD) .
DLT Evaluation : The first two cycles serve as the dose-limiting toxicity (DLT) observation window .
Endpoint : The recommended Phase 2 dose (RP2D) will be determined by investigator assessment Receives: Drug: T-DXd |
| Phase I/Arm B(Systemic-to-Intrathecal Transition Phase) | Experimental | Population : T-DXd-naïve subjects with LM ± BM. Cycle 1 : IV T-DXd monotherapy to characterize CSF and systemic PK profiles. Cycles 2+ : IT administration of the RP2D of T-DXd combined with IV therapy Receives: Drug: T-DXd |
| Phase II/Arm A | Experimental | HER2-positive advanced breast cancer with progressive leptomeningeal and/or brain metastases after prior T-DXd therapy Receives: Drug: T-DXd |
| Phase II/Arm B | Experimental | HER2-low (IHC 1+ or 2+/ISH-) advanced breast cancer with progressive leptomeningeal and/or brain metastases after prior T-DXd therapy Receives: Drug: T-DXd |
| Phase II/Arm C | Experimental | HER2-positive advanced breast cancer with progressive brain metastases (without leptomeningeal involvement) after prior T-DXd therapy Receives: Drug: T-DXd |
| Phase II/Arm D | Experimental | HER2-low advanced breast cancer with progressive brain metastases (without leptomeningeal involvement) after prior T-DXd therapy Receives: Drug: T-DXd |
| Phase II/Arm E | Experimental | T-DXd-naïve HER2-positive advanced breast cancer with progressive leptomeningeal and/or brain metastases Receives: Drug: T-DXd |
| Phase II/Arm F | Experimental | T-DXd-naïve HER2-low advanced breast cancer with progressive leptomeningeal and/or brain metastases Receives: Drug: T-DXd |
| Phase II/Arm G | Experimental | T-DXd-naïve HER2-positive advanced breast cancer with progressive brain metastases (without leptomeningeal involvement) Receives: Drug: T-DXd |
| Phase II/Arm H | Experimental | T-DXd-naïve HER2-low advanced breast cancer with progressive brain metastases (without leptomeningeal involvement) Receives: Drug: T-DXd |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I Stage Cohort A: Maximum Tolerated Dose (MTD)
Cohort A: Maximum Tolerated Dose (MTD) of intracapsular administration，In the dose increment stage, the highest dose whose estimated DLT rate is closest to the target DLT rate but does not exceed the upper bound of the equivalent interval of DLT rate is selected as MTD.
Measured: Up to 21 days after the first dose
Phase I Stage Cohort B: Maximum serum concentration (Cmax)
Cohort B: Maximum serum concentration (Cmax) of T-DXd in cerebrospinal fluid and blood will be investigated.
Measured: Up to 21 days after the first dose
Phase I Stage Cohort B:Time to maximum serum concentration (Tmax)
Cohort B: Time to maximum serum concentration (Tmax) of T-DXd in cerebrospinal fluid and blood will be investigated.
Measured: Up to 21 days after the first dose
Phase I Stage Cohort B:Half-life (T1/2)
Cohort B: Half-life (T1/2) of T-DXd in cerebrospinal fluid and blood will be investigated.
Measured: Up to 21 days after the first dose
Phase II Stage Cohorts A: LM-OS
Cohorts A: leptomeningeal metastasis-overall survival（LM-OS）
Measured: 18 months
Phase II Stage Cohorts B: LM-OS
Cohorts B: leptomeningeal metastasis-overall survival（LM-OS）
Measured: 18 months
Phase II Stage Cohorts C: LM-ORR
Cohorts C: leptomeningeal metastasis-Objective Response Rate（LM-ORR）
Measured: 18 months
Phase II Stage Cohorts D: LM-ORR
Cohorts D: leptomeningeal metastasis-Objective Response Rate（LM-ORR）
Measured: 18 months
Phase II Stage Cohorts E: LM-OS
Cohorts E: leptomeningeal metastasis-overall survival（LM-OS）
Measured: 18 months
Phase II Stage Cohorts F: LM-OS
Cohorts F: leptomeningeal metastasis-overall survival（LM-OS）
Measured: 18 months
Phase II Stage Cohorts G: LM-ORR
Cohorts G: leptomeningeal metastasis-Objective Response Rate（LM-ORR）
Measured: 18 months
Phase II Stage Cohorts H: LM-ORR
Cohorts H: leptomeningeal metastasis-Objective Response Rate（LM-ORR）
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2025
- Study start12 May 2025
- Primary completion30 Jan 2027 (estimated)
- Study completion28 Jun 2027 (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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 139 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian Zhang,MD, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07134153
- Sponsor's protocol ID
- 2501313-7
- Acronym
- INOVATE
- Status last verified
- Oct 2026
- First submitted
- 11 May 2025
- Last updated
- 26 Oct 2026
- 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 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Safety and Efficacy of INtrathecal or Ommaya ReserVoir Administration of T-DXd in Patients With HER2-Expressing Breast Cancer With Active Leptomeningeal and/or Brain Metastases Based on Systemic Therapy: Phase I/II Study
- ClinicalTrials.gov ID
- NCT07134153
- Acronym / sponsor ID
- INOVATE / 2501313-7
- Conditions
- Breast Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 139 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 12 May 2025 (actual)
- Primary completion
- 30 Jan 2027 (estimated)
- Study completion
- 28 Jun 2027 (estimated)
- First posted
- 21 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.
Multiple trials confirm systemic T-DXd efficacy in HER2+ breast cancer with leptomeningeal/brain metastases, yet median LM survival remains 3-4 months, highlighting unmet needs. While systemic therapies improve survival, intracranial disease control remains limited due to poor BBB penetration. Preclinical data show no detectable T-DXd/DXd in CSF, though intrathecal trastuzumab demonstrates preliminary safety/efficacy in HER2+ LM.
This study evaluates intrathecal/intra-Ommaya T-DXd plus systemic therapy in active HER2+ meningeal/brain metastases, assessing safety, intracranial efficacy, and CSF/peripheral blood T-DXd distribution to clarify BBB penetration potential. Findings may guide novel therapeutic strategies for this high-need population.
Detailed description
Multiple clinical trials have demonstrated the efficacy of systemic T-DXd in advanced HER2-expressing breast cancer with leptomeningeal and/or brain metastases. However, the median survival of leptomeningeal metastasis (LM) patients remains only 3-4 months, and treatment options for isolated brain metastases are limited, underscoring the need for more effective therapeutic strategies.
While systemic therapies have prolonged survival in advanced breast cancer, intracranial disease management remains constrained by a lack of effective local treatments. As the use of T-DXd increases, the progression of intracranial lesions in patients who have received prior local therapy or lack indications for radiotherapy has become a critical unmet clinical challenge.
Conventional understanding holds that large biologic molecules poorly penetrate the blood-brain barrier (BBB). Preclinical studies detected neither T-DXd nor free DXd (payload) in cerebrospinal fluid (CSF), and the distribution of T-DXd in human CSF remains uncharacterized. However, preliminary data suggest that intrathecal trastuzumab-alone or combined with pertuzumab-exhibits acceptable safety and efficacy in HER2-positive LM.
Correction Notice: The Study Start Date was initially listed as April 18, 2025 (the date of Ethics Committee approval). It has been corrected to May 12, 2025, which is the actual date of first participant enrollment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Phase I/Arm A(Intrathecal Dose-Escalation Phase) | Experimental | Drug: T-DXdPopulation : T-DXd-naïve subjects with leptomeningeal metastases (LM), with or without concurrent brain metastases (BM). Cycle 1 : Intrathecal (IT) T-DXd monotherapy to assess cerebrospinal fluid (CSF) and systemic pharmacokinetics (PK). Cycles 2+ : IT T-DXd combined with intravenous (IV) T-DXd in a dose-escalation design to determine the maximum tolerated dose (MTD) . DLT Evaluation : The first two cycles serve as the dose-limiting toxicity (DLT) observation window . Endpoint : The recommended Phase 2 dose (RP2D) will be determined by investigator assessment |
| Phase I/Arm B(Systemic-to-Intrathecal Transition Phase) | Experimental | Drug: T-DXdPopulation : T-DXd-naïve subjects with LM ± BM. Cycle 1 : IV T-DXd monotherapy to characterize CSF and systemic PK profiles. Cycles 2+ : IT administration of the RP2D of T-DXd combined with IV therapy |
| Phase II/Arm A | Experimental | Drug: T-DXdHER2-positive advanced breast cancer with progressive leptomeningeal and/or brain metastases after prior T-DXd therapy |
| Phase II/Arm B | Experimental | Drug: T-DXdHER2-low (IHC 1+ or 2+/ISH-) advanced breast cancer with progressive leptomeningeal and/or brain metastases after prior T-DXd therapy |
| Phase II/Arm C | Experimental | Drug: T-DXdHER2-positive advanced breast cancer with progressive brain metastases (without leptomeningeal involvement) after prior T-DXd therapy |
| Phase II/Arm D | Experimental | Drug: T-DXdHER2-low advanced breast cancer with progressive brain metastases (without leptomeningeal involvement) after prior T-DXd therapy |
| Phase II/Arm E | Experimental | Drug: T-DXdT-DXd-naïve HER2-positive advanced breast cancer with progressive leptomeningeal and/or brain metastases |
| Phase II/Arm F | Experimental | Drug: T-DXdT-DXd-naïve HER2-low advanced breast cancer with progressive leptomeningeal and/or brain metastases |
| Phase II/Arm G | Experimental | Drug: T-DXdT-DXd-naïve HER2-positive advanced breast cancer with progressive brain metastases (without leptomeningeal involvement) |
| Phase II/Arm H | Experimental | Drug: T-DXdT-DXd-naïve HER2-low advanced breast cancer with progressive brain metastases (without leptomeningeal involvement) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥18 years, regardless of gender.
- HER2-expressing advanced or metastatic breast cancer
- Leptomeningeal metastasis
- Subjects with active brain metastases only must have at least one intracranially measurable lesion (RANO-BM criteria).
- Adequate organ and bone marrow function
Key exclusion criteria (11 listed)
- Diagnosis of other malignancies within the past 5 years, except for cured carcinoma in situ of the cervix, basal cell carcinoma or squamous cell carcinoma of the skin, other in situ carcinomas, or papillary thyroid carcinoma.
- Uncontrolled concurrent illnesses including, but not limited to: persistent or active infections, uncontrolled or clinically significant cardiovascular diseases, severe chronic gastrointestinal disorders with diarrhea, or psychiatric/social conditions that may compromise compliance with study requirements, significantly increase AE risks, or impair the subject's ability to provide written informed consent.
- History of (non-infectious) ILD/non-infectious pneumonitis requiring steroid therapy, current ILD/non-infectious pneumonitis, or suspected ILD/non-infectious pneumonitis that cannot be ruled out by imaging during screening.
- Clinically significant pulmonary comorbidities
- Use of immunosuppressants or systemic corticosteroids (>10 mg/day prednisone equivalent) for immunosuppression within 2 weeks prior to first dose (excluding intranasal/inhaled corticosteroids).
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: DS8201aEvaluating safety and efficacy of intrathecal or ommaya reservoir administration of T-DXd in patients with HER2-expressing breast cancer with active leptomeningeal and/or brain metastases based on systemic therapy | Drug | Phase I/Arm A(Intrathecal Dose-Escalation Phase), Phase I/Arm B(Systemic-to-Intrathecal Transition Phase), Phase II/Arm A, Phase II/Arm B, Phase II/Arm C, Phase II/Arm D, Phase II/Arm E, Phase II/Arm F, Phase II/Arm G, Phase II/Arm H |
Primary outcome
Phase I Stage Cohort A: Maximum Tolerated Dose (MTD)
Time frame: Up to 21 days after the first dose
Cohort A: Maximum Tolerated Dose (MTD) of intracapsular administration，In the dose increment stage, the highest dose whose estimated DLT rate is closest to the target DLT rate but does not exceed the upper bound of the equivalent interval of DLT rate is selected as MTD.
Phase I Stage Cohort B: Maximum serum concentration (Cmax)
Time frame: Up to 21 days after the first dose
Cohort B: Maximum serum concentration (Cmax) of T-DXd in cerebrospinal fluid and blood will be investigated.
Phase I Stage Cohort B:Time to maximum serum concentration (Tmax)
Time frame: Up to 21 days after the first dose
Cohort B: Time to maximum serum concentration (Tmax) of T-DXd in cerebrospinal fluid and blood will be investigated.
Phase I Stage Cohort B:Half-life (T1/2)
Time frame: Up to 21 days after the first dose
Cohort B: Half-life (T1/2) of T-DXd in cerebrospinal fluid and blood will be investigated.
Phase II Stage Cohorts A: LM-OS
Time frame: 18 months
Cohorts A: leptomeningeal metastasis-overall survival（LM-OS）
Phase II Stage Cohorts B: LM-OS
Time frame: 18 months
Cohorts B: leptomeningeal metastasis-overall survival（LM-OS）
Phase II Stage Cohorts C: LM-ORR
Time frame: 18 months
Cohorts C: leptomeningeal metastasis-Objective Response Rate（LM-ORR）
Phase II Stage Cohorts D: LM-ORR
Time frame: 18 months
Cohorts D: leptomeningeal metastasis-Objective Response Rate（LM-ORR）
Phase II Stage Cohorts E: LM-OS
Time frame: 18 months
Cohorts E: leptomeningeal metastasis-overall survival（LM-OS）
Phase II Stage Cohorts F: LM-OS
Time frame: 18 months
Cohorts F: leptomeningeal metastasis-overall survival（LM-OS）
Phase II Stage Cohorts G: LM-ORR
Time frame: 18 months
Cohorts G: leptomeningeal metastasis-Objective Response Rate（LM-ORR）
Phase II Stage Cohorts H: LM-ORR
Time frame: 18 months
Cohorts H: leptomeningeal metastasis-Objective Response Rate（LM-ORR）
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 26 Oct 2026.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing T-DXd in people with Breast Cancer, run by Fudan University 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 7 inclusion and 11 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 26 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 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Contact Jian Zhang, MD, PhD (+8664175590 ext. 85000, syner2000@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase I Stage Cohort A: Maximum Tolerated Dose (MTD) (time frame: Up to 21 days after the first dose). The study lists 12 primary outcomes in all. 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 26 Oct 2026.