HER2-negative Breast CancerPhase 4NCT06230055
Intrathecal Chemotherapy Through Ommaya Reservoir Upon Her-2 Negative Breast Cancer With Leptomeningeal Metastasis
A Phase 4 study testing Ommaya reservoir, Systematic chemotherapy and Intrathecal chemotherapy in people with HER2-negative Breast Cancer and Leptomeningeal Metastasis, run by Fudan University at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HER2-negative Breast Cancer, Leptomeningeal Metastasis
- What is being tested?
- Ommaya reservoir, Systematic chemotherapy and Intrathecal chemotherapy
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteChina
- Study dates
- 5 Jan 2024to 1 Jan 2027
- Phase
- Phase 4
- 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
- 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 result);
- 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 suggests pia enhancement;
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- The function of major organs was good, which was confirmed by the following laboratory tests during the screening period:
- Platelet count ≥8010^9/L
- Hemoglobin ≥8g/L
- Neutrophil count ≥1.510^9/L
- Serum creatinine ≤1.5ULN
- ALT and AST≤ 3ULN (if liver metastases are present, ALT and AST≤5ULN)
- Serum total bilirubin ≤1.5ULN
- International Standardized ratio (INR) and Activated partial thromboplastin time (APTT) ≤1.5ULN
- 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 contraception, the blood/urine pregnancy test results of female patients of childbearing age within 7 days before enrollment were negative.
- Subjects 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 the corresponding AE does not pose a safety risk.
Who cannot join
- 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 recurred within five years; Both primary cancers are expected to benefit from this study. Investigators have identified the primary tumor source of the metastases);
- 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;
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- 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: subjects 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 subjects, only those whose polymerase chain reaction showed negative HCV RNA were eligible for enrollment (chronic hepatitis B or chronic hepatitis C patients with stable disease receiving standard antiviral therapy were eligible for enrollment);
- 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 arrhythmias (except atrial fibrillation and paroxysmal supraventricular tachycardia);
- Subjects had clinically significant prolonged QTcF
- High blood pressure that is not well controlled;
- The researcher believes that the patient has other conditions that are not suitable for participating in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center; Department of Oncology, Shanghai Medical College, Fudan University
Shanghai, Shanghai Municipality, 200032
Yuxin Mu, 34778299
About this study
Official title: Clinical Outcome and Quality of Life of Intrathecal Chemotherapy Through Ommaya Reservoir in Combination With Systematic Chemotherapy Versus Systematic Chemotherapy Upon Her-2 Negative Breast Cancer With Leptomeningeal Metastasis (CONQUER)
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.
- Being tested
- Ommaya reservoir, Systematic chemotherapy, Intrathecal chemotherapy
- Medical subject headings
- Meningeal Carcinomatosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ommaya reservoirDevice
Intrathecal chemotherapy through Ommaya reservoir
Systematic chemotherapyDrug
Systematic chemotherapy: including capecitabine(1000mg/m2 bid, d1-14, q3w, po), gemcitabine(1000mg/m2, d1,8, q3w, ivgtt), vinorelbine(60mg/m2, qw, po), docetaxel(75mg/m2, d1, q3w, ivgtt),Nab-paclitaxel(125mg/m2, d1,8, q3w, ivgtt), iribrin(1.4mg/m2, d1,8, q3w, ivgtt), DS8201(5.4mg/kg, d1, q3w, ivgtt), sacituzumab govitecan(10mg/kg, d1,8, q3w, ivgtt) or SKB264(5mg/kg, d1, q2w, ivgtt).
Intrathecal chemotherapyDrug
Intrathecal chemotherapy through Ommaya reservoir: including MTX(10-12mg, q1-3w), thiotepa(10mg, q1-3w), cytarabine(30mg/m2, q1-3w), cytarabine liposome(50mg, q1-3w), pemetrexed(50mg, q1-3w), or DS8201(The frequency and cycle of drug administration are determined based on the results of the Phase I/II clinical trial of intrathecal injection of DS8201 in our center).
| Study group | Role | What they receive |
|---|---|---|
| intrathecal chemotherapy through Ommaya reservoir in combination with systematic chemotherapy | Experimental | Intrathecal chemotherapy through Ommaya reservoir: including MTX(10-12mg, q1-3w), thiotepa(10mg, q1-3w), cytarabine(30mg/m2, q1-3w), cytarabine liposome(50mg, q1-3w), pemetrexed(50mg, q1-3w), or DS8201(The frequency and cycle of drug administration are determined based on the results of the Phase I/II clinical trial of intrathecal injection of DS8201 in our center).
Systematic chemotherapy: including capecitabine(1000mg/m2 bid, d1-14, q3w, po), gemcitabine(1000mg/m2, d1,8, q3w, ivgtt), vinorelbine(60mg/m2, qw, po), docetaxel(75mg/m2, d1, q3w, ivgtt),Nab-paclitaxel(125mg/m2, d1,8, q3w, ivgtt), iribrin(1.4mg/m2, d1,8, q3w, ivgtt), DS8201(5.4mg/kg, d1, q3w, ivgtt), sacituzumab govitecan(10mg/kg, d1,8, q3w, ivgtt) or SKB264(5mg/kg, d1, q2w, ivgtt). Receives: Device: Ommaya reservoir; Drug: Systematic chemotherapy; Drug: Intrathecal chemotherapy |
| systematic chemotherapy | Active comparator | Systematic chemotherapy: including capecitabine(1000mg/m2 bid, d1-14, q3w, po), gemcitabine(1000mg/m2, d1,8, q3w, ivgtt), vinorelbine(60mg/m2, qw, po), docetaxel(75mg/m2, d1, q3w, ivgtt),Nab-paclitaxel(125mg/m2, d1,8, q3w, ivgtt), iribrin(1.4mg/m2, d1,8, q3w, ivgtt), DS8201(5.4mg/kg, d1, q3w, ivgtt), sacituzumab govitecan(10mg/kg, d1,8, q3w, ivgtt) or SKB264(5mg/kg, d1, q2w, ivgtt). Receives: Drug: Systematic chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neural progression-free survival (NPFS)
Clinical outcome of intrathecal chemotherapy through Ommaya reservoir in combination with systematic chemotherapy versus systematic chemotherapy Upon Her-2 negative breast cancer with leptomeningeal metastasis: Neural progression-free survival (NPFS) calculated from the randomized date until first observation of meningeal metastasis progression (LM-PD) or death (whichever occurs earlier). Neural progression, according to the RANO-LM criteria, is defined as: neurological examination/worsening of symptoms, or CSF cytological progression, or imaging progression.
Measured: Six months after the last patient was enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start5 Jan 2024
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-negative 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 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
- NCT06230055
- Sponsor's protocol ID
- CONQUER
- Status last verified
- Oct 2025
- First submitted
- 29 Dec 2023
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcome and Quality of Life of Intrathecal Chemotherapy Through Ommaya Reservoir in Combination With Systematic Chemotherapy Versus Systematic Chemotherapy Upon Her-2 Negative Breast Cancer With Leptomeningeal Metastasis (CONQUER)
- ClinicalTrials.gov ID
- NCT06230055
- Acronym / sponsor ID
- CONQUER
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 5 Jan 2024 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 29 Jan 2024 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intrathecal chemotherapy through Ommaya reservoir in combination with systematic chemotherapy | Experimental | Device: Ommaya reservoir, Drug: Systematic chemotherapy, Drug: Intrathecal chemotherapyIntrathecal chemotherapy through Ommaya reservoir: including MTX(10-12mg, q1-3w), thiotepa(10mg, q1-3w), cytarabine(30mg/m2, q1-3w), cytarabine liposome(50mg, q1-3w), pemetrexed(50mg, q1-3w), or DS8201(The frequency and cycle of drug administration are determined based on the results of the Phase I/II clinical trial of intrathecal injection of DS8201 in our center). Systematic chemotherapy: including capecitabine(1000mg/m2 bid, d1-14, q3w, po), gemcitabine(1000mg/m2, d1,8, q3w, ivgtt), vinorelbine(60mg/m2, qw, po), docetaxel(75mg/m2, d1, q3w, ivgtt),Nab-paclitaxel(125mg/m2, d1,8, q3w, ivgtt), iribrin(1.4mg/m2, d1,8, q3w, ivgtt), DS8201(5.4mg/kg, d1, q3w, ivgtt), sacituzumab govitecan(10mg/kg, d1,8, q3w, ivgtt) or SKB264(5mg/kg, d1, q2w, ivgtt). |
| systematic chemotherapy | Active comparator | Drug: Systematic chemotherapySystematic chemotherapy: including capecitabine(1000mg/m2 bid, d1-14, q3w, po), gemcitabine(1000mg/m2, d1,8, q3w, ivgtt), vinorelbine(60mg/m2, qw, po), docetaxel(75mg/m2, d1, q3w, ivgtt),Nab-paclitaxel(125mg/m2, d1,8, q3w, ivgtt), iribrin(1.4mg/m2, d1,8, q3w, ivgtt), DS8201(5.4mg/kg, d1, q3w, ivgtt), sacituzumab govitecan(10mg/kg, d1,8, q3w, ivgtt) or SKB264(5mg/kg, d1, q2w, ivgtt). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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 result);
- Failure of standard treatment, or intolerance to standard treatment;
Key exclusion criteria (21 listed)
- 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 recurred within five years; Both primary cancers are expected to benefit from this study. Investigators have identified the primary tumor source of the metastases);
- 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;
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 |
|---|---|---|
| Ommaya reservoirIntrathecal chemotherapy through Ommaya reservoir | Device | intrathecal chemotherapy through Ommaya reservoir in combination with systematic chemotherapy |
| Systematic chemotherapySystematic chemotherapy: including capecitabine(1000mg/m2 bid, d1-14, q3w, po), gemcitabine(1000mg/m2, d1,8, q3w, ivgtt), vinorelbine(60mg/m2, qw, po), docetaxel(75mg/m2, d1, q3w, ivgtt),Nab-paclitaxel(125mg/m2, d1,8, q3w, ivgtt), iribrin(1.4mg/m2, d1,8, q3w, ivgtt), DS8201(5.4mg/kg, d1, q3w, ivgtt), sacituzumab govitecan(10mg/kg, d1,8, q3w, ivgtt) or SKB264(5mg/kg, d1, q2w, ivgtt). | Drug | intrathecal chemotherapy through Ommaya reservoir in combination with systematic chemotherapy, systematic chemotherapy |
| Intrathecal chemotherapyIntrathecal chemotherapy through Ommaya reservoir: including MTX(10-12mg, q1-3w), thiotepa(10mg, q1-3w), cytarabine(30mg/m2, q1-3w), cytarabine liposome(50mg, q1-3w), pemetrexed(50mg, q1-3w), or DS8201(The frequency and cycle of drug administration are determined based on the results of the Phase I/II clinical trial of intrathecal injection of DS8201 in our center). | Drug | intrathecal chemotherapy through Ommaya reservoir in combination with systematic chemotherapy |
Primary outcome
Neural progression-free survival (NPFS)
Time frame: Six months after the last patient was enrolled
Clinical outcome of intrathecal chemotherapy through Ommaya reservoir in combination with systematic chemotherapy versus systematic chemotherapy Upon Her-2 negative breast cancer with leptomeningeal metastasis: Neural progression-free survival (NPFS) calculated from the randomized date until first observation of meningeal metastasis progression (LM-PD) or death (whichever occurs earlier). Neural progression, according to the RANO-LM criteria, is defined as: neurological examination/worsening of symptoms, or CSF cytological progression, or imaging progression.
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 25 Nov 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ommaya reservoir, Systematic chemotherapy and Intrathecal chemotherapy in people with HER2-negative Breast Cancer and Leptomeningeal Metastasis, run by Fudan University at 1 site 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 18 inclusion and 21 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 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 (+8664175590, syner2000@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neural progression-free survival (NPFS) (time frame: Six months after the last patient was enrolled). 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 25 Nov 2025.