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Tests treatment safety and results for Breast Cancer
Official title Exploration of the Safety and Efficacy of T-DXd Concurrent With Brain Radiotherapy in Patients With Brain Metastases HER2-positive/HER2-low Advanced Breast Cancer
ClinicalTrials.gov ID: NCT07117864
What this study is testing
What is T-DXd concurrent brain radiotherapy?
T-DXd concurrent brain radiotherapy is an investigational medicine, being studied as a potential treatment for breast cancer.
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
- A study on the safety and efficacy of T-DXd in combination with local radiotherapy for brain metastases in HER2-Positive and HER2-Low breast cancer patients.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75, women only
You may be able to join if
- Female patients aged ≥18 and ≤75 years with histologically confirmed breast cancer.
- ECOG performance status of 0 to 2.
- HER2-positive or HER2-low invasive breast cancer, defined as: HER2-positive: IHC 3+ or IHC 2+ with FISH amplification; HER2-low: IHC 2+ without FISH...
- Confirmed diagnosis of breast cancer brain metastases.
- Patients may have received prior chemotherapy (from first-line to multiple lines), HER2-targeted therapy (monoclonal antibodies), endocrine therapy...
You likely can't join if
- Tumor-Related Symptoms and Treatments
- Uncontrolled moderate to large pleural effusion, ascites, or pericardial effusion requiring repeated drainage;
- Imaging (CT or MRI) showing tumor invasion of major blood vessels, or cases deemed by the investigator as highly likely to cause fatal hemorrhage due...
- Signs of meningeal irritation such as neck stiffness, seizures, or cognitive impairment, or confirmed leptomeningeal metastasis by imaging (CT or...
- Uncontrolled or symptomatic hypercalcemia (defined as ionized calcium \> 1.5 mmol/L, serum calcium \> 12 mg/dL, or albumin-corrected serum calcium \>...
- Prior cranial radiotherapy;
See the full eligibility criteria
- Female patients aged ≥18 and ≤75 years with histologically confirmed breast cancer.
- ECOG performance status of 0 to 2.
- HER2-positive or HER2-low invasive breast cancer, defined as: HER2-positive: IHC 3+ or IHC 2+ with FISH amplification; HER2-low: IHC 2+ without FISH amplification, or IHC 1+.
- Confirmed diagnosis of breast cancer brain metastases.
- Patients may have received prior chemotherapy (from first-line to multiple lines), HER2-targeted therapy (monoclonal antibodies), endocrine therapy, and immunotherapy.
- Adequate organ function as defined below: Hematology: Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L; Platelet count (PLT) ≥ 80 × 10⁹/L (no blood transfusion within 14 days prior to first dose); Hemoglobin (Hb) ≥ 80 g/L...
- people must voluntarily participate in the study and provide signed informed consent.
- Tumor-Related Symptoms and Treatments
- Uncontrolled moderate to large pleural effusion, ascites, or pericardial effusion requiring repeated drainage;
- Imaging (CT or MRI) showing tumor invasion of major blood vessels, or cases deemed by the investigator as highly likely to cause fatal hemorrhage due to vascular invasion during the study period;
- Signs of meningeal irritation such as neck stiffness, seizures, or cognitive impairment, or confirmed leptomeningeal metastasis by imaging (CT or MRI) or lumbar puncture;
- Uncontrolled or symptomatic hypercalcemia (defined as ionized calcium \> 1.5 mmol/L, serum calcium \> 12 mg/dL, or albumin-corrected serum calcium \> ULN), or symptomatic hypercalcemia requiring continued bisphosphonate...
- Prior cranial radiotherapy;
- Prior treatment with trastuzumab deruxtecan (T-DXd).
- Comorbidities / Medical History
- History of other malignancies for which the patient received any systemic anti-cancer therapy or local treatment (including surgery or radiotherapy), except for adequately treated cervical carcinoma in situ, basal cell...
- Major surgery unrelated to breast cancer within 4 weeks prior to enrollment, or incomplete recovery from such surgery (diagnostic biopsies and PICC line placement are permitted);
- Known or suspected autoimmune diseases, except for the following conditions: Hypothyroidism due to autoimmune thyroiditis managed with hormone replacement therapy; Stable Type I diabetes mellitus with controlled blood...
- Presence of interstitial lung disease (ILD), non-infectious pneumonitis, or uncontrolled systemic diseases (e.g., diabetes, pulmonary fibrosis, acute pneumonia);
- HIV infection or known AIDS; active hepatitis (HBV defined as HBV-DNA ≥ 500 IU/mL; HCV defined as HCV-RNA above the lower limit of detection); concurrent HBV and HCV infection; autoimmune hepatitis;
- Severe infections within 4 weeks before first dose (e.g., bacteremia or severe pneumonia requiring hospitalization), or active infections requiring systemic antibiotic therapy of CTCAE grade ≥2 within 2 weeks before...
- Previous or planned allogeneic bone marrow transplantation or solid organ transplantation; Severe or uncontrolled cardiovascular disease, including but not limited to: History of heart failure or systolic dysfunction...
- Known hypersensitivity to the investigational drug or any of its excipients, or a history of severe hypersensitivity reactions to other monoclonal antibodies.
- Pregnant or breastfeeding women, women of childbearing potential with a positive baseline pregnancy test, or women of childbearing potential unwilling to use effective contraception during the study.
- History of confirmed neurological or psychiatric disorders, including epilepsy or dementia; known history of psychiatric medication abuse, alcoholism, or substance abuse.
- Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in this study.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing 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 female, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing 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.