RecruitingPhase 1 / Phase 2interventionalRules rewrite

Phase 1 / Phase 2: testing T-DXd for Breast Cancer

Multiple trials confirm systemic T-DXd how well it works 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.

Official registry: https://clinicaltrials.gov/study/NCT07134153 · Fudan University · enrollment listed as 139

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are T-DXd. The registry lists allocation as randomized. Multiple trials confirm systemic T-DXd how well it works in HER2+ breast cancer with leptomeningeal/brain metastases, yet median LM survival remains 3-4 months, highlighting unmet needs.

They plan to enroll about 139 people at 2 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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

Interventions: T-DXd

Primary outcome (registry wording): Phase I Stage Cohort A: Maximum Tolerated Dose (MTD)

Who it is for (from inclusion criteria)

Ages 18 Years to any
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 the registry excludes

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
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
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

Public study contact (from the registry)

Jian Zhang, MD, PhD

+8664175590

syner2000@163.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

2 listed

Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (recruiting)
Fudan University Shanghai Cancer Cancer — Shanghai, Shanghai Municipality, China (recruiting)

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FAQ about this NCT record

Is NCT07134153 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07134153?

Phase 1 / Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07134153?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary