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FSRT in Breast Cancer Patients With Brain Metastases

Primary Purpose

Breast Cancer, Brain Metastases

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Fractionated stereotactic radiotherapy(FSRT)

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Fudan University Shanghai Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FSRT

Arm Description

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.

Outcomes

Primary Outcome Measures

intracranial local tumor control rate

Secondary Outcome Measures

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.

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

overall survival(OS)

time from the date of informed consent until to the date of death, regardless of the cause of death.

Adverse events

AEs were graded according to the National Cancer Institute's Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.3

Full Information

NCT ID

NCT04061408

First Posted

August 16, 2019

Last Updated

August 16, 2019

Sponsor

Fudan University

1. Study Identification

Unique Protocol Identification Number

NCT04061408

Brief Title

FSRT in Breast Cancer Patients With Brain Metastases

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Unknown status

Study Start Date

July 1, 2019 (Actual)

Primary Completion Date

July 2021 (Anticipated)

Study Completion Date

July 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer, Brain Metastases

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

170 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

FSRT

Arm Type

Experimental

Arm Description

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.

Intervention Type

Radiation

Intervention Name(s)

Fractionated stereotactic radiotherapy(FSRT)

Intervention Description

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 Measure Information:

Title

intracranial local tumor control rate

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Intracranial distant metastasis rate

Description

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.

Time Frame

2 years

Title

Intracranial Progression-Free Survival (PFS)

Description

Time from the date of radiotherapy to the investigator-determined date of progression or death due to any cause, whichever occurs first

Time Frame

2 years

Title

overall survival(OS)

Description

time from the date of informed consent until to the date of death, regardless of the cause of death.

Time Frame

3 years

Title

Adverse events

Description

AEs were graded according to the National Cancer Institute's Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.3

Time Frame

2 years

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jin Meng

Phone

+86 18121299532

jademj@126.com

Facility Information:

Facility Name

Fudan University Shanghai Cancer Center

City

Shanghai

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Zhaozhi Yang, PhD

Phone

+8618017317126

yzzhi2014@163.com

First Name & Middle Initial & Last Name & Degree

Jin Meng

Phone

+8618121299532

jademj@126.com

First Name & Middle Initial & Last Name & Degree

Zhaozhi Yang, PhD

12. IPD Sharing Statement

Plan to Share IPD

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FSRT in Breast Cancer Patients With Brain Metastases

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