Testing Sacituzumab Govitecan Therapy in Patients With HER2-Negative Breast Cancer and Brain Metastases
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|ClinicalTrials.gov Identifier: NCT04647916|
Recruitment Status : Recruiting
First Posted : December 1, 2020
Last Update Posted : July 12, 2021
|Condition or disease||Intervention/treatment||Phase|
|Anatomic Stage IV Breast Cancer AJCC v8 Invasive Breast Carcinoma Metastatic HER2 Negative Breast Carcinoma Metastatic Malignant Neoplasm in the Brain Prognostic Stage IV Breast Cancer AJCC v8||Biological: Sacituzumab Govitecan||Phase 2|
I. To evaluate the intracranial objective response rate (ORR) (complete response [CR] or partial response [PR] by Response Assessment in Neuro-Oncology Brain Metastases [RANO-BM]) with sacituzumab govitecan (IMMU-132) in patients with HER2-negative metastatic breast cancer with brain involvement.
I. To evaluate bi-compartmental progression-free survival in this population. II. To evaluate overall survival in this population. III. To assess safety and tolerability of sacituzumab govitecan (IMMU-132) treatment in this population.
IV. To evaluate ORR by hormone-receptor (HR) subgroup (HR+, HR-).
I. To bank specimens for future correlative studies.
Patients receive sacituzumab govitecan intravenously (IV) over 1-3 hours on days 1 and 8. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
After completion of study registration, patients are followed up every 3 months for 1 year and then every 6 months for 1 year.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||44 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Sacituzumab Govitecan (IMMU-132) (NSC #820016) for Patients With HER2-Negative Breast Cancer and Brain Metastases|
|Actual Study Start Date :||December 15, 2020|
|Estimated Primary Completion Date :||December 17, 2024|
|Estimated Study Completion Date :||February 2025|
Experimental: Treatment (sacituzumab govitecan)
Patients receive sacituzumab govitecan IV over 1-3 hours on days 1 and 8. Cycles repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
Biological: Sacituzumab Govitecan
- Objective response rate (ORR) [ Time Frame: Up to 2 years ]ORR will be evaluated using use a Simon two-stage minimax design.
- Overall survival [ Time Frame: From date of registration to date of death due to any cause, assessed up to 2 years ]Will use the Kaplan-Meier curves to estimate the respective survival curves.
- Progression-free survival [ Time Frame: From date of registration to date of first documentation of progression or symptomatic deterioration or death due to any cause, assessed up to 2 years ]Will use the Kaplan-Meier curves to estimate the respective survival curves.
- Incidence of adverse events [ Time Frame: Up to 2 years ]Adverse events will be graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The incidence of adverse events will be reported. Toxicity will be by grade and attribution to treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04647916
|Principal Investigator:||Andrew J Brenner||Southwest Oncology Group|