FSRT in Breast Cancer Patients With Brain Metastases

NCT04061408 | Unknown Phase 2

• 1 other identifier: FDRT-BC009
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer; Brain Metastases

Outcome Measures

Primary Outcomes (1)

• intracranial local tumor control rate

  2 years

Secondary Outcomes (4)

• Intracranial distant metastasis rate

  2 years

• Intracranial Progression-Free Survival (PFS)

  2 years

• overall survival(OS)

  3 years

• Adverse events

  2 years

Study Arms (1)

FSRT

EXPERIMENTAL

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.

Radiation: Fractionated stereotactic radiotherapy(FSRT)

Interventions

Fractionated stereotactic radiotherapy(FSRT) RADIATION

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.

FSRT

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed HER2 positive advanced breast cancer
• Age\>18 years.
• 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

You may not qualify if:

• 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
• Patients who are receiving cytotoxic drug concomitantly
• Have received prior radiotherapy for brain metastasis

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Brain Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Jin Meng

CONTACT

+86 18121299532; jademj@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2019
• First Posted: August 19, 2019
• Study Start: July 1, 2019
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2022
• Last Updated: August 19, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)