To hear about similar clinical trials, please enter your email below
Trial Title:
Sacituzumab Govitecan and Intrathecal Chemotherapy for Treating Leptomeningeal Metastases From Her2-negative Breast Cancer
NCT ID:
NCT06462092
Condition:
Leptomeningeal Metastases
Conditions: Official terms:
Neoplasm Metastasis
Meningeal Carcinomatosis
Pemetrexed
Sacituzumab govitecan
Conditions: Keywords:
Breast cancer
Her2- (Human Epidermal Growth Factor Receptor 2 Negative)
Leptomeningeal Metastases
Sacituzumab Govitecan
Pemetrexed
Intrathecal chemotherapy
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Sacituzumab Govitecan
Description:
Patients receive Sacituzumab Govitecan 10mg/kg by intravenous infusion on days 1 and 8.
Treatment cycles are every 21 days.
Arm group label:
Group
Other name:
Trodelvy
Intervention type:
Drug
Intervention name:
Pemetrexed
Description:
Pemetrexed intrathecal chemotherapy is administered by intracerebroventricular or lumbar
puncture. Pemetrexed intrathecal chemotherapy is divided into induction, consolidation
and maintenance phases. Induction therapy was first performed with a single dose of 15 mg
twice a week for 2 weeks for a total of 4 doses. This was followed by consolidation
therapy, 1 time per week for 4 consecutive weeks for a total of 4 times.
Arm group label:
Group
Other name:
ALIMTA
Summary:
Leptomeningeal metastases is a specific pattern of central involvement in which tumor
cells invade and proliferate in the subarachnoid space, and is a lethal complication of
malignant tumors. Leptomeningeal metastases from Her2-negative breast cancer is still
tricky to treat at present, with an overall median survival of only 3-6 months, even
after aggressive treatment. This study is an open, uncontrolled phase I/II clinical study
to observe the safety, feasibility, and potential efficacy of Sacituzumab Govitecan
combined with pemetrexed intrathecal chemotherapy in the treatment of patients with
Her2-negative breast cancer leptomeningeal metastases in search of a more effective
treatment.
Detailed description:
This study is a single-arm prospective phase I/II clinical trial to observe the safety,
feasibility, and potential efficacy of Sacituzumab Govitecan combined with pemetrexed
intrathecal chemotherapy in the treatment of patients with Her2-negative breast cancer
leptomeningeal metastases. Patients were treated with Sacituzumab Govitecan 10mg/kg,
infused intravenously on days 1 and 8. Treatment cycles were every 21 days and continued
until disease progression or unacceptable toxicity. Pemetrexed intrathecal chemotherapy
was initiated on Day 2 after Sacituzumab Govitecan administration. Pemetrexed intrathecal
chemotherapy is administered by intracerebroventricular or lumbar puncture. Pemetrexed
intrathecal chemotherapy is divided into induction, consolidation and maintenance phases.
Induction therapy was first performed with a single dose of 15 mg twice a week for 2
weeks for a total of 4 doses. This was followed by consolidation therapy, 1 time per week
for 4 consecutive weeks for a total of 4 times. Patients whose treatment was evaluated as
effective were given maintenance therapy once a month until relapse or death. A minimum
of 3 patients and a maximum of 6 patients were recruited into the phase I cohort. When
dose-limiting toxicity occurred in ≥2 patients, the treatment regimen was considered to
be excessively side-effective, and a reduction in the intrathecal chemotherapy dose of
pemetrexed to a single 10-mg dose was given, with continued enrollment of 6 consecutive
patients. If DLT occurred again in ≥2 patients, the trial would be stopped. Otherwise,
the study entered a phase II trial when DLT occurred in ≤1 patient.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. A clear histopathologic diagnosis of breast cancer with subtype Her2- (including IHC
0, IHC 1+ or IHC 2+ and ISH negative).
2. Cerebrospinal fluid cytology diagnosis confirms the presence of leptomeningeal
metastases; or imaging combined with patient symptoms and signs are consistent with
the diagnosis of leptomeningeal metastases;
3. Age ≥ 18 years old;
Exclusion Criteria:
1. Inadequate organ function: 1) Blood tests: ANC ≤ 1.5 x 10^9/L, PLT ≤ 90 x 10^9/L, Hb
≤ 90 g/L; 2) Blood biochemistry tests: TBIL ≥ 1.5 times the upper limit of normal;
3) ALT and AST ≥ 2.5 times the upper limit of normal;
2. Presence of serious and/or uncontrolled comorbidities that may affect participation:
1) allergy to study drugs or adjuvant materials; 2) history of immunodeficiency,
including HIV-positive or other acquired or congenital immunodeficiency diseases; 3)
severe concomitant diseases;
3. Pregnant and breastfeeding female patients; women of childbearing age who are
unwilling to Female patients of childbearing age who are using effective
contraception;
4. Any other condition that, in the opinion of the investigator, makes the patient
ineligible for participation in the study.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
June 15, 2024
Completion date:
June 15, 2027
Lead sponsor:
Agency:
Guangzhou Medical University
Agency class:
Other
Source:
Guangzhou Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06462092
