FSRT in Breast Cancer Patients With Brain Metastases

Breast Cancer Clinical Trial

Official title:

A Phase II Pilot Study of Fractionated Stereotactic Radiotherapy(FSRT) in Breast Cancer Patients With 1 to 10 Brain Metastases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04061408
• Other study ID #: FDRT-BC009
• Status: Recruiting
• Phase: Phase 2
• Start date: July 1, 2019
• Est. completion date: July 2022

Study information

• Verified date: August 2019
• Source: Fudan University
• Contact: Jin Meng
• Phone: +86 18121299532
• Email: jademj[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Brain metastasis accounted for 10-15% of all breast cancer patients and even higher in patients with triple negative and HER2 overexpressed subtype. Stereotactic radiation is the standard option for patients with 1-4 brain metastases. Among patients with 1-4 brain metastases, many studies suggest that stereotactic radiation results in fewer neurologic side effects than whole brain radiation. Also, several studies had demonstrated that 5-10 lesions had similar overall survival by using whole brain radiotherapy or stereotactic radiotherapy. Fractionated stereotactic radiotherapy(FSRT) is increasingly administered in the brain metastatic patients and retrospective studies had shown that FSRT had better local control and lower brain radiation necrosis than single fraction stereotactic radiation. Therefore, In this study, we explore to treat 1-10 brain metastasis lesion in breast cancer patients with FSRT.

Description:

Breast cancer patients with 1-10 brain metastasis will be treated with FSRT for brain metastasis. 3 to 5 fractions and 8Gy per fraction will be used for these patients based on the lesion number and volume.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 170
• Est. completion date: July 2022
• Est. primary completion date: July 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Histologically confirmed HER2 positive advanced breast cancer

• Age>18 years.

• 1 to 10 brain metastases confirmed by enhanced brain MRI

• KPS=70

• Life expectancy of more than 12 weeks

• Prior therapy of oral dexamethasone not exceeding 16mg/d

• Time interval from prior therapy was more than 2 weeks, and evaluation of adverse events is no more than grade 1.

• Maximum diameter of intracranial metastases is less than 3cm measured by enhanced brain MRI(2-3mm)

• Prior endocrine therapy were allowed

• Anti-Her2 targeted treatment were allowed

• Screening laboratory values must meet the following criteria( and should be obtained within 28 days prior to registration):

Absolute Neutrophil Count (ANC) = 1.5 x 109/L, Platelets= 90 x 109/L, Hemoglobin = 90 g/L Aspartate aminotransferase/alanine aminotransferase (AST/ALT) =2.5 x ULN without liver metastasis,= 5 x ULN with liver metastases Serum BUN and creatinine = 1.5 x Upper Limit of Normal (ULN)

• Time interval from chemotherapy was more than 2 weeks, endocrine therapy and anti-Her2 targeted treatment are allowed to be used concurrently with FSRT

• Signed the informed consent form prior to patient entry

Exclusion Criteria:

• Leptomeningeal or hemorrhagic metastases

• Uncontrolled epilepsy

• Severe complication: cardiovascular disease, end-stage renal disease, severe hepatic disease, infection etc.

• Pregnancy or lactation period, women of child-bearing age who are unwilling to accept contraceptive measures.

• Inability to complete enhanced MRI

• Patients who are difficult or unable to be followed-up

• Not suitable for inclusion for specific reasons judged by sponsor

• Patients who are receiving cytotoxic drug concomitantly

• Have received prior radiotherapy for brain metastasis

Related Conditions & MeSH terms

• Brain Metastases
• Brain Neoplasms
• Breast Cancer
• Breast Neoplasms
• Neoplasm Metastasis

Intervention

Radiation:
• Fractionated stereotactic radiotherapy(FSRT)
3 to 5 fractions and 8Gy per fraction will be used for breast cancer patients with 1-10 brain metastases based on the lesion number and volume.

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	intracranial local tumor control rate		2 years
Secondary	Intracranial distant metastasis rate	intracranial distant metastasis after FSRT will be determined by the development of intracranial distant metastasis is determined by new lesions outside of the irradiated area.	2 years
Secondary	Intracranial Progression-Free Survival (PFS)	Time from the date of radiotherapy to the investigator-determined date of progression or death due to any cause, whichever occurs first	2 years
Secondary	overall survival(OS)	time from the date of informed consent until to the date of death, regardless of the cause of death.	3 years
Secondary	Adverse events	AEs were graded according to the National Cancer Institute's Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.3	2 years