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Trial Title:
Sacituzumab Govitecan Combined With Head Radiotherapy for Her2-negative Breast Cancer Brain Metastases
NCT ID:
NCT06462079
Condition:
Brain Metastasis
Conditions: Official terms:
Neoplasm Metastasis
Brain Neoplasms
Sacituzumab govitecan
Conditions: Keywords:
Breast cancer
Her2- (Human Epidermal Growth Factor Receptor 2 Negative)
Brain metastasis
Sacituzumab Govitecan
Radiation therapy
Study type:
Interventional
Study phase:
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 were treated with Sacituzumab Govitecan 10 mg/kg in 21-day treatment cycles with
intravenous infusions on days 1 and 8 and continued until disease progression or
unacceptable toxicity.
Arm group label:
Group
Other name:
Trodelvy
Intervention type:
Radiation
Intervention name:
Radiotherapy
Description:
Radiotherapy was administered after the second infusion of Sacituzumab Govitecan, on day
9 after the start of this regimen. The radiotherapy regimen was: brain metastases at a
dose of 60 Gy/20 doses. For lesions located adjacent to the brainstem and optic nerve, 54
Gy/20 doses were given. For patients with ≥5 lesions, whole-brain radiotherapy at 40
Gy/20 doses was synchronized with radiotherapy to localized brain metastases.
Arm group label:
Group
Summary:
The incidence of brain metastasis of Her2-negative breast cancer is high, which seriously
affects the prognosis of patients.The treatment of brain metastasis of Her2-negative
breast cancer is still tricky. The local efficacy of head radiotherapy for breast cancer
brain metastases is remarkable, and systemic tumor progression in patients with brain
metastases is the main reason for treatment failure. Sacituzumab Govitecan is the only
Trop-2 antibody-coupled drug (ADC) approved for the treatment of unresectable locally
advanced or metastatic Her2-negative breast cancer. However, the objective remission rate
of Sacituzumab Govitecan for intracranial metastatic lesions has not been satisfactory.
This study is an open, uncontrolled phase II clinical study to observe the efficacy and
safety of Sacituzumab Govitecan combined with intracranial radiotherapy in the treatment
of patients with brain metastases from Her2-negative breast cancer, in order to find a
more effective treatment method.
Detailed description:
This study is a single-arm open phase II clinical trial. It aims to observe the
effectiveness and safety of Sacituzumab Govitecan combined with head radiotherapy in the
treatment of Her2-negative breast cancer brain metastases, and to search for a more
effective treatment option for Her2-negative breast cancer brain metastases. Patients
were treated with Sacituzumab Govitecan 10mg/kg every 21 days as a treatment cycle, which
was infused intravenously on day 1 and day 8, and the treatment was continued until the
disease progressed or unacceptable toxicity occurred. Radiotherapy was administered after
the second infusion of Sacituzumab Govitecan, on day 9 after the start of this regimen.
The radiotherapy regimen was: brain metastases at a dose of 60 Gy/20 doses. For lesions
located adjacent to the brainstem and optic nerve, 54 Gy/20 doses were given. For
patients with ≥5 lesions, whole-brain radiotherapy at 40 Gy/20 doses was synchronized
with radiotherapy to localized brain metastases.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Have a definitive pathologic diagnosis of breast cancer with subtype Her2-
(including IHC 0, IHC 1+ or IHC 2+ and ISH negative);
2. Have a measurable intracranial lesion;
3. Age ≥ 18 years;
Exclusion Criteria:
1. Patients with cerebrospinal membrane metastases;
2. Patients with acute/subacute hemorrhagic metastasis;
3. Inadequate organ function: 1) Blood tests: ANC ≤ 1.5 x 10^9/L, PLT ≤ 90 x 10^9/L, Hb
≤ 90g/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;
4. Presence of serious and/or uncontrolled comorbidities that may affect participation:
1) allergy to study medications or adjuvant materials; 2) history of
immunodeficiency, including HIV-positive or other acquired or congenital
immunodeficiency diseases; 3) serious concomitant illnesses;
5. Pregnant and lactating female patients; female patients of childbearing age who are
unwilling to use effective contraception during the trial period;
6. Patients who are unable to complete enhanced contrast MRI;
7. Patients who have been treated with Sacituzumab Govitecan and are resistant to the
drug;
8. Any other condition that, in the opinion of the investigator, makes the patient
ineligible for study participation.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
June 15, 2024
Completion date:
July 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/NCT06462079
