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FSRT in Breast Cancer Patients With Brain Metastases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04061408
Recruitment Status : Unknown
Verified August 2019 by Fudan University.
Recruitment status was:  Recruiting
First Posted : August 19, 2019
Last Update Posted : August 19, 2019
Information provided by (Responsible Party):
Fudan University

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Brain Metastases Radiation: Fractionated stereotactic radiotherapy(FSRT) Phase 2

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Pilot Study of Fractionated Stereotactic Radiotherapy(FSRT) in Breast Cancer Patients With 1 to 10 Brain Metastases
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: 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.
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.

Primary Outcome Measures :
  1. intracranial local tumor control rate [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Intracranial distant metastasis rate [ Time Frame: 2 years ]
    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. Intracranial Progression-Free Survival (PFS) [ Time Frame: 2 years ]
    Time from the date of radiotherapy to the investigator-determined date of progression or death due to any cause, whichever occurs first

  3. overall survival(OS) [ Time Frame: 3 years ]
    time from the date of informed consent until to the date of death, regardless of the cause of death.

  4. Adverse events [ Time Frame: 2 years ]
    AEs were graded according to the National Cancer Institute's Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.3

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04061408

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Contact: Jin Meng +86 18121299532

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Fudan University Shanghai Cancer Center Recruiting
Shanghai, China
Contact: Zhaozhi Yang, PhD    +8618017317126   
Contact: Jin Meng    +8618121299532   
Principal Investigator: Zhaozhi Yang, PhD         
Sponsors and Collaborators
Fudan University
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Responsible Party: Fudan University Identifier: NCT04061408    
Other Study ID Numbers: FDRT-BC009
First Posted: August 19, 2019    Key Record Dates
Last Update Posted: August 19, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasm Metastasis
Brain Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes
Central Nervous System Neoplasms
Nervous System Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases