Sacituzumab Govitecan Combined With Head Radiotherapy for Her2-negative Breast Cancer Brain Metastases

Launched by GUANGZHOU MEDICAL UNIVERSITY · Jun 12, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with brain metastases from Her2-negative breast cancer, which means the cancer has spread to the brain and is not responding to standard treatments. The researchers want to see if combining a medication called Sacituzumab Govitecan with radiation therapy to the head can improve treatment outcomes. Sacituzumab Govitecan is an antibody-drug that targets cancer cells, but so far, it hasn't worked well for brain lesions. This study aims to find out if the combination can help patients more effectively.

To be eligible for this trial, participants must be adults aged 18 and older with a confirmed diagnosis of Her2-negative breast cancer and have measurable brain lesions. Some patients may be excluded if they have certain health conditions, such as serious organ problems or if they have received the treatment before without success. Those who join the study can expect to undergo regular assessments to monitor their response to the treatment and safety. This trial is not yet recruiting participants, but it hopes to discover a better way to treat this challenging condition.

Gender

ALL

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.