Breast Cancer With Brain Metastasis Clinical Trial
Official title:
A Phase II Study of Stereotactic Radiosurgery Plus HER-2 Directed Therapy in HER2-positive Breast Cancer With Brain Metastasis
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
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.
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