Clinical trial NCT03617341: Brain Monitoring for High Risk of Brain Metastases in Metastatic Breast Cancer
Official title: Brain Monitoring for High Risk of Brain Metastases in Metastatic Breast Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Metastatic Breast Cancer With HER2 Positive
Triple Negative Breast Cancer
Keywords: Breast cancer
brain metastases
screening
brain MRI
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2018-08-06
Enrollment: 200
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who were initial diagnosed with HER2-positive, triple negative metastatic breast cancer

Brief summary: In general, brain metastases found after development of neurologic symptoms have poor prognosis. Therefore, the investigators aim to investigate whether regular brain MRI (Magnetic Resonance Imaging) can detect early brain metastases and influence survival through early brain management in HER2-positive and triple negative breast cancer.

Detailed description: It is well known that HER2-receptor positive and triple negative metastatic breast cancer (MBC) have poor prognosis than hormone receptor positive metastatic breast cancer. However, as new therapies such as trastuzumab and pertuzumab are introduced, overall survival was extended in patients with metastatic breast cancer compared with the previous 10 years. As a result, the number of breast cancer patients with brain metastases has increased, the demand for treatments of brain metastases is increasing.

The incidence of brain metastases in MBC has been reported to be 7.6% and 10.8% in luminal A / B, respectively. However, HER2-positive and triple negative breast cancer with the incidence of more than 30% of brain metastases were at high risk group of brain metastases.

In general, brain metastases found after development of neurologic symptoms have poor prognosis. Therefore, the investigators aim to investigate whether regular brain MRI (Magnetic Resonance Imaging) can detect early brain metastases and influence survival through early brain management in HER2-positive and triple negative breast cancer.

Eligibility criteria: Inclusion Criteria:

* Patients over 19 years
* Pathologically documented breast cancer that:

  1. is unresectable or metastatic ;
  2. has confirmed HER2 positive expression according to American Society of Clinical Oncology- College of American Pathologists (ASCO-CAP) guidelines or triple negative breast cancer
* No prior systemic palliative treatment of metastatic breast cancer
* Must have provided informed consent for study participation before performance of any study-specific procedures or tests

Exclusion Criteria:

* History of prior treatments about brain metastases or leptomeningeal metastases
* Symptomatic brain metastases at screening period
* Has received more than second-line systemic treatments (including endocrine therapy)
* For subjects who have difficulty lying down or who have claustrophobia, they can undergo sedation during brain MRI
* History of hypersensitivity reaction to contrast or drug allergic reaction
* Patients who inserted metallic prosthesis (pacemaker, denture, hearing aid, aneurysm clip, metallic material of eyeball, artificial joint, insulin pump, chemo-port, temporary tissue expander for breast reconstruction, etc) can be conducted after consultation with investigator before MRI.
* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
* Social, familial, or geographical factors that would interfere with study participation or follow-up

Primary outcomes:
measure: The incidence rates of brain metastases with high risk patients in metastatic breast cancer
timeFrame: 5 years
Secondary outcomes:
measure: The incidence rate of brain oligometastasis (≤ 4) confirmed by brain MRI
timeFrame: 5 years
measure: Intracranial progression free survival(PFS) after treatment of brain metastases
timeFrame: 5 years
measure: The overall survival (OS) after diagnosis to brain metastases
timeFrame: 5 years
measure: The period from diagnosis to treatment of brain metastases
timeFrame: 5 years
measure: The cognitive impairment assessment after brain metastases
timeFrame: 5 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei Cancer Center, Severance Hospital, Yonsei University Health System
Study officials:
References: