Trial of Neratinib Plus Capecitabine in Subjects With HER2-Negative Metastatic Breast Cancer With Brain Metastases and Abnormally Active HER2 Signaling
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|ClinicalTrials.gov Identifier: NCT04965064|
Recruitment Status : Not yet recruiting
First Posted : July 16, 2021
Last Update Posted : July 11, 2022
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Capecitabine and Neratinib.||Phase 2|
The purpose of this research is to look at the safety and effectiveness of a HER2-targeted therapy neratinib when given with capecitabine, a chemotherapy, for breast cancer patients with brain metastases whose tumors were HER2-negative by standard tests but showed abnormal HER2 activity based on the CELsignia results. The CELsignia test results might predict whether this breast cancer type will respond to treatment with neratinib and capecitabine.
Neratinib is called a HER2-targeted therapy because it stops cancer cells from growing by targeting and blocking the HER2 proteins that help cancer cells grow. Neratinib is an oral drug approved by the U.S. Food and Drug Administration (FDA) to treat HER2-positive breast cancer. It is considered investigational in this study because your breast cancer was determined to be HER2-negative by the standard method of testing. However, the CELsignia test showed that your breast cancer cells have HER2 pathway activity that might respond to HER2-targeted treatment.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label Phase II Trial of Neratinib Plus Capecitabine in Subjects With HER2-Negative Metastatic Breast Cancer With Brain Metastases and Abnormally Active HER2 Signaling|
|Estimated Study Start Date :||August 1, 2022|
|Estimated Primary Completion Date :||November 1, 2023|
|Estimated Study Completion Date :||November 1, 2023|
Experimental: Experimental: Capecitabine and Neratinib.
Neratinib 240 mg PO QD Daily On-going
Capecitabine 750 mg/m2 PO bid Days 1-14, 7 days off On-going
Drug: Capecitabine and Neratinib.
Neratinib 240 mg PO QD Daily On-going Capecitabine 750 mg/m2 PO bid Days 1-14, 7 days off On-going
- overall survival [ Time Frame: 24 months ]The study will assess how long participants with HER2 negative metastatic breast cancer with brain metastasis and abnormal HER2 signalling will survive if treated with capecitabine and neratinib
- CNS progression free survival [ Time Frame: 24 months ]The study will assess how long participants with HER2 negative metastatic breast cancer with brain metastasis and abnormal HER2 signalling will survive and also not have the cancer get worse in the brain while treated with capecitabine and neratinib
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): NCT04965064
|Contact: Laura Mitchell||(585) 275-7763||Laura_Mitchell@URMC.Rochester.edu|