Breast CancerPhase 2NCT04061408
FSRT in Breast Cancer Patients With Brain Metastases
A Phase 2 study testing Fractionated stereotactic radiotherapy(FSRT) in people with Breast Cancer and Brain Metastases, run by Fudan University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer, Brain Metastases
- What is being tested?
- Fractionated stereotactic radiotherapy(FSRT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2019to Jul 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- Not suitable for inclusion for specific reasons judged by sponsor
- Patients who are receiving cytotoxic drug concomitantly
- Have received prior radiotherapy for brain metastasis
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai
Zhaozhi Yang, PhD, +8618017317126, yzzhi2014@163.com
Jin Meng, +8618121299532, jademj@126.com
About this study
Official title: A Phase II Pilot Study of Fractionated Stereotactic Radiotherapy(FSRT) in Breast Cancer Patients With 1 to 10 Brain Metastases
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.
Read the 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.
- Conditions
- Breast Cancer, Brain Metastases
- Being tested
- Fractionated stereotactic radiotherapy(FSRT)
- Medical subject headings
- Breast Neoplasms, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Radiation: Fractionated stereotactic radiotherapy(FSRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
intracranial local tumor control rate
Measured: 2 years
Secondary outcomes (4)
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.
Measured: 2 years
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
Measured: 2 years
overall survival(OS)
time from the date of informed consent until to the date of death, regardless of the cause of death.
Measured: 3 years
Adverse events
AEs were graded according to the National Cancer Institute's Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0.3
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2019
- Study start1 Jul 2019
- Primary completionJul 2021 (estimated)
- Study completionJul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04061408
- Sponsor's protocol ID
- FDRT-BC009
- Status last verified
- Aug 2019
- First submitted
- 16 Aug 2019
- Last updated
- 19 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Pilot Study of Fractionated Stereotactic Radiotherapy(FSRT) in Breast Cancer Patients With 1 to 10 Brain Metastases
- ClinicalTrials.gov ID
- NCT04061408
- Acronym / sponsor ID
- FDRT-BC009
- Conditions
- Breast Cancer, Brain Metastases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 19 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FSRT | Experimental | 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Radiation | FSRT |
Primary outcome
intracranial local tumor control rate
Time frame: 2 years
4 secondary outcomes
Intracranial distant metastasis rate
Time frame: 2 years
Intracranial Progression-Free Survival (PFS)
Time frame: 2 years
overall survival(OS)
Time frame: 3 years
Adverse events
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fractionated stereotactic radiotherapy(FSRT) in people with Breast Cancer and Brain Metastases, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jin Meng (+86 18121299532, jademj@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intracranial local tumor control rate (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2019.