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New treatment option for Breast Cancer
Official title Phase I/II Study of Intrathecal/Ommaya T-DXd in HER2-Expressing Breast Cancer With Leptomeningeal/Brain Metastases
ClinicalTrials.gov ID: NCT07134153
What this study is testing
What is T-DXd?
T-DXd is an investigational medicine, being studied as a potential treatment for breast cancer.
Also referred to as DS8201a.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥18 years, regardless of gender.
- HER2-expressing advanced or metastatic breast cancer
- Leptomeningeal metastasis
- people with active brain metastases only must have at least one intracranially measurable lesion (RANO-BM criteria).
- Adequate organ and bone marrow function
You likely can't join if
- Diagnosis of other malignancies within the past 5 years, except for cured carcinoma in situ of the cervix, basal cell carcinoma or squamous cell...
- Uncontrolled concurrent illnesses including, but not limited to: persistent or active infections, uncontrolled or clinically significant...
- History of (non-infectious) ILD/non-infectious pneumonitis requiring steroid therapy, current ILD/non-infectious pneumonitis, or suspected...
- Clinically significant pulmonary comorbidities
- Use of immunosuppressants or systemic corticosteroids (\>10 mg/day prednisone equivalent) for immunosuppression within 2 weeks prior to first dose...
- Any active autoimmune disease or history of autoimmune disease with potential recurrence.
See the full eligibility criteria
- Age ≥18 years, regardless of gender.
- HER2-expressing advanced or metastatic breast cancer
- Leptomeningeal metastasis
- people 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
- 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...
- Uncontrolled concurrent illnesses including, but not limited to: persistent or active infections, uncontrolled or clinically significant cardiovascular diseases, severe chronic gastrointestinal disorders with diarrhea...
- 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...
- 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.
- 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 people 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 people of reproductive potential unwilling/unable to use effective contraception.
- Any other condition deemed by investigators to potentially affect trial conduct or outcome interpretation.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.