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New treatment option for HER2-negative Breast Cancer
Official title Intrathecal Chemotherapy Through Ommaya Reservoir Upon Her-2 Negative Breast Cancer With Leptomeningeal Metastasis
ClinicalTrials.gov ID: NCT06230055
What this study is testing
What is Systematic chemotherapy?
Systematic chemotherapy is an investigational medicine, being studied as a potential treatment for her2-negative 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
- This is a prospective, multicenter, randomized controlled, open-label investigator-initiated clinical study to evaluate the clinical efficacy and quality of life of intrathecal chemotherapy through Ommaya reservoir in combination with systematic chemotherapy versus systemic chemotherapy alone in patients with Her-2 negative breast cancer with leptomeningeal metastasis.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
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
- Male or female aged 18 years or above;
- Can understand the purpose of clinical trials and the benefits and risks, voluntarily participate in and sign the informed consent
- The physical status score of the Eastern Oncology Consortium (ECOG) was ≤3;
- HER2-metastatic breast cancer confirmed histologically or cytologically (HER2- is defined as either a standard immunohistochemical (IHC) test result...
- Failure of standard treatment, or intolerance to standard treatment;
You likely can't join if
- Pregnant or lactating women;
- Patients with acute and chronic infections, or with other serious diseases at the same time, were judged not suitable for this study;
- Other malignant tumors within 5 years (except the following cases: cured skin basal cell carcinoma, cervical carcinoma in situ, thyroid papillary...
- Mental illness or mental disorder, poor compliance can not cooperate with and describe treatment response;
- There are serious organic diseases or major organ failure, such as decompensated heart and lung failure, which can not tolerate treatment;
- Patients with bleeding tendency;
See the full eligibility criteria
- Male or female aged 18 years or above;
- Can understand the purpose of clinical trials and the benefits and risks, voluntarily participate in and sign the informed consent
- The physical status score of the Eastern Oncology Consortium (ECOG) was ≤3;
- HER2-metastatic breast cancer confirmed histologically or cytologically (HER2- is defined as either a standard immunohistochemical (IHC) test result of 0 or 1+, or an IHC test result of 2+ and a negative ISH test...
- Failure of standard treatment, or intolerance to standard treatment;
- pial metastasis is present, which is defined as meningeal metastasis confirmed by malignant tumor cells found in cerebrospinal fluid cytology; Or clinical symptoms/signs suggest meningeal metastasis, and brain MRI...
- The function of major organs was good, which was confirmed by the following laboratory tests during the screening period: Platelet count ≥80\ 10\^9/L Hemoglobin ≥8g/L Neutrophil count ≥1.5\ 10\^9/L Serum creatinine...
- NYHA cardiac function grade ≤II, no obvious abnormality in ECG, or no clinical significance according to the investigators;
- Voluntary compliance with the trial protocol during the study period and regular follow-up;
- For all women of childbearing age, fertile men or their spouses who did not plan to have children or donate sperm during the entire trial period until 6 months after the last dose, or who voluntarily took effective...
- people who have recovered from non-hematological toxicity from the last treatment (CTCAE≤ class 1, except for special conditions such as "alopecia") before first administration, and who the investigator determines that...
- Pregnant or lactating women;
- Patients with acute and chronic infections, or with other serious diseases at the same time, were judged not suitable for this study;
- Other malignant tumors within 5 years (except the following cases: cured skin basal cell carcinoma, cervical carcinoma in situ, thyroid papillary carcinoma; A second primary cancer that has been eradicated and has not...
- Mental illness or mental disorder, poor compliance can not cooperate with and describe treatment response;
- There are serious organic diseases or major organ failure, such as decompensated heart and lung failure, which can not tolerate treatment;
- Patients with bleeding tendency;
- Patients who have received organ transplants;
- Patients taking adrenal corticosteroids or immunosuppressants for a long time;
- Intracranial hemorrhage unrelated to tumor disease;
- Patients with central nervous system complications requiring urgent treatment;
- Test group: people who could not collect CSF;
- The subject has a history of immunodeficiency, including HIV testing positive, or other acquired or congenital immunodeficiency diseases;
- Active viral hepatitis B (HBsAg positive with HBV DNA≥500 IU/mL) or hepatitis C. Among hepatitis C antibody positive people, only those whose polymerase chain reaction showed negative HCV RNA were eligible for...
- The subject has a serious cardiovascular clinical disease or symptom, including: Congestive heart failure History of unstable angina; myocardial infarction within the past six months; Clinically significant malignant...
- The researcher believes that the patient has other conditions that are not suitable for participating in this study.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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.