FSRT in Breast Cancer Patients With Brain Metastases
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ClinicalTrials.gov 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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Breast Cancer Brain Metastases | Radiation: Fractionated stereotactic radiotherapy(FSRT) | Phase 2 |
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 |

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.
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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. |
- intracranial local tumor control rate [ Time Frame: 2 years ]
- 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.
- 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
- 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.
- 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

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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

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 ClinicalTrials.gov identifier (NCT number): NCT04061408
Contact: Jin Meng | +86 18121299532 | jademj@126.com |
China | |
Fudan University Shanghai Cancer Center | Recruiting |
Shanghai, China | |
Contact: Zhaozhi Yang, PhD +8618017317126 yzzhi2014@163.com | |
Contact: Jin Meng +8618121299532 jademj@126.com | |
Principal Investigator: Zhaozhi Yang, PhD |
Responsible Party: | Fudan University |
ClinicalTrials.gov 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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Breast Neoplasms Neoplasm Metastasis Brain Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
Neoplastic Processes Pathologic Processes Central Nervous System Neoplasms Nervous System Neoplasms Brain Diseases Central Nervous System Diseases Nervous System Diseases |