Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2026-01-03 @ 6:49 PM
Study NCT ID:
NCT01924351
Status:
WITHDRAWN
Last Update Posted:
2020-03-18
First Post:
2013-08-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
HER2-positive Breast Cancer With Brain Metastasis (GCC 1345)
Sponsor:
University of Maryland, Baltimore
Organization:
Study Overview
Official Title:
A Phase II Study of Stereotactic Radiosurgery Plus HER-2 Directed Therapy in HER2-positive Breast Cancer With Brain Metastasis
Status:
WITHDRAWN
Status Verified Date:
2020-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Primary Objective:
To determine if treatment with SRS followed by a HER-2 directed therapy regimen results in a 6-month distant brain relapse rate of less than 30%.
Secondary Objectives:
1. Describe the natural history of neurocognitive function for women with brain metastases treated with SRS and HER-2 directed systemic therapy and establish a reference benchmark to generate hypothesis for future design of a phase III trial.
2. Describe patterns of distant brain relapse after SRS for all patients and compare them between (a) patients with 1-3 vs. 4-10 brain metastasis and (b) between patients treated with each systemic therapy regimen
3. Describe patterns of neurologic death
4. Describe patterns of local brain relapse
5. Describe patterns of re-irradiation with WBRT or SRS
6. Describe adverse events
To determine if treatment with SRS followed by a HER-2 directed therapy regimen results in a 6-month distant brain relapse rate of less than 30%.
Secondary Objectives:
1. Describe the natural history of neurocognitive function for women with brain metastases treated with SRS and HER-2 directed systemic therapy and establish a reference benchmark to generate hypothesis for future design of a phase III trial.
2. Describe patterns of distant brain relapse after SRS for all patients and compare them between (a) patients with 1-3 vs. 4-10 brain metastasis and (b) between patients treated with each systemic therapy regimen
3. Describe patterns of neurologic death
4. Describe patterns of local brain relapse
5. Describe patterns of re-irradiation with WBRT or SRS
6. Describe adverse events
Detailed Description:
Metastatic breast cancer is a leading cause of death for women. HER2(human epidermal growth factor receptor type 2)-positive disease represents a more aggressive type of breast cancer which often afflicts younger patients. As many as one-third of patients with HER2-positive breast cancer develop brain metastasis\[1\]. The development of brain metastasis in this young female population is particularly devastating as they are often highly functional and may have young children. Improvement in quality of life by preventing neurocognitive decline from disease progression and/or treatment related side effects is paramount.
Patients with 1-10 brain metastasis from HER2+ breast cancer, after informed consent, will be treated with:
Radiosurgery: Gamma-knife, Cyberknife, or linac-based SRS is followed by anti-HER2 based systemic therapy, with the treatment selection of approved agents at the physician's discretion. Possible anti-HER2 agents include trastuzumab, pertuzumab, trastuzumab-emtansine, or lapatinib. Anti-HER2 therapy will be delivered in combination with appropriate cytotoxic therapy as per FDA indications.
Anti-HER2 based systemic therapy will continue until progression, patient discontinuation, unacceptable toxicity or if, in the view of the physician it is no longer indicated.
MRI and neurocognitive testing will be done prior to SRS and repeated every 3 months during the first 6 months from enrollment.
Patients can only be enrolled after all eligibility criteria are met. The date of registration/enrollment is considered to be the day the Eligibility Checklist is signed by the verifying physician. Once a patient is enrolled, a unique case number will be assigned to the patient.
Patients with 1-10 brain metastasis from HER2+ breast cancer, after informed consent, will be treated with:
Radiosurgery: Gamma-knife, Cyberknife, or linac-based SRS is followed by anti-HER2 based systemic therapy, with the treatment selection of approved agents at the physician's discretion. Possible anti-HER2 agents include trastuzumab, pertuzumab, trastuzumab-emtansine, or lapatinib. Anti-HER2 therapy will be delivered in combination with appropriate cytotoxic therapy as per FDA indications.
Anti-HER2 based systemic therapy will continue until progression, patient discontinuation, unacceptable toxicity or if, in the view of the physician it is no longer indicated.
MRI and neurocognitive testing will be done prior to SRS and repeated every 3 months during the first 6 months from enrollment.
Patients can only be enrolled after all eligibility criteria are met. The date of registration/enrollment is considered to be the day the Eligibility Checklist is signed by the verifying physician. Once a patient is enrolled, a unique case number will be assigned to the patient.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: