Breast CancerPhase 1NCT00916877
Prophylactic Cranial Irradiation in Patients With HER-2-Positive Metastatic Breast Cancer
A Phase 1 study testing Prophylactic Cranial Irradiation in people with Breast Cancer, run by Alberta Health services at 1 site in Canada.
Trial summary
Though brain metastases are a risk in all patients with breast cancer, those with HER-2 overexpression are at significantly greater risk. One series estimated a 30% incidence of brain metastases in this population, while another study found an incidence of approximately 40%. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Prophylactic Cranial Irradiation
- Type of treatment
- Surgery or procedure
- How many people
- 110 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2009to Mar 2011
- Phase
- Phase 1
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female with HER2-positive disease
- 18 years of age or older
- ECOG greater or equal to 2
- Life expectancy greater or equal to 6 months
- Able to complete self administered quality of life evaluations and neurocognitive testing
- Willing and able to comply with study instructions and commit to all clinic visits for the duration of the study
- Women of child-bearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test at the baseline visit and must use highly effective birth control during study
- Signed informed consent form
Who cannot join
- Current malignancy in the brain, as determined by screening MRI/CT done no more then 6 weeks prior to study treatment with PCI
- Chemo or radiation planned during the period when patients will receive study treatment with PCI
- Prior radiotherapy of the brain
- Prior stroke or brain hemorrhage in the 6 months prior to screening
- History of neurological/psychiatric disorders, including psychotic disorders or demential, or any other reason, which may affect neurocognitive assessment
- Inadequate renal function
- Other known previous or concomitant serious illness or medical condition that may interfere with participation in the study
Trial locations and contacts
1 site in 1 country.
About this study
Though brain metastases are a risk in all patients with breast cancer, those with HER-2 overexpression are at significantly greater risk. One series estimated a 30% incidence of brain metastases in this population, while another study found an incidence of approximately 40%. Traditional systemic therapies do not cross the blood brain barrier to any significant degree or at all, but radiation treatment can be effective in the treatment of intracranial metastases.
Read the detailed description
The rationale for PCI is that the brain is a sanctuary site where cancer cells can remain inaccessible to chemotheraphy and agents such as trastuzumab due to the blood brain barrier, which prevents potentially harmful chemicals such as chemotherapy agents and antibodies such as trastuzumab from reaching the brain. Decreasing the incidence of brain metastasis with acceptable effects on neurocognitive function would be a significant improvement in the care of patients with MBC.
- Conditions
- Breast Cancer
- Being tested
- Prophylactic Cranial Irradiation
- Keywords
- Prophylactic Cranial Irradiation, Her-2-positive met breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prophylactic Cranial IrradiationRadiation
Prophylactic Cranial Irradiation
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety of PCI, specifically with respect to neurocognitive function in patients with HER-2-positive metastatic breast cancer.
Measured: approximately 2 to 3 years from study start
Secondary outcomes (1)
To assess the impact of PCI on measures of survival, specifically brain metastases-free survival, overall progression free survival and overall survival
Measured: approximately 4 years from study start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2009 (estimated)
- Study startNov 2009
- Primary completionMar 2011
- Study completionMar 2011
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.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alberta Health services
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00916877
- Sponsor's protocol ID
- Inhouse
- Status last verified
- Aug 2011
- First submitted
- 8 Jun 2009
- Last updated
- 8 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Cranial Irradiation in Patients With HER-2-Positive Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00916877
- Acronym / sponsor ID
- Inhouse
- Conditions
- Breast Cancer
- Keywords
- Prophylactic Cranial Irradiation, Her-2-positive met breast cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Alberta Health servicesUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 10 Jun 2009 (estimated)
- 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.
Though brain metastases are a risk in all patients with breast cancer, those with HER-2 overexpression are at significantly greater risk. One series estimated a 30% incidence of brain metastases in this population, while another study found an incidence of approximately 40%. Traditional systemic therapies do not cross the blood brain barrier to any significant degree or at all, but radiation treatment can be effective in the treatment of intracranial metastases.
Detailed description
The rationale for PCI is that the brain is a sanctuary site where cancer cells can remain inaccessible to chemotheraphy and agents such as trastuzumab due to the blood brain barrier, which prevents potentially harmful chemicals such as chemotherapy agents and antibodies such as trastuzumab from reaching the brain. Decreasing the incidence of brain metastasis with acceptable effects on neurocognitive function would be a significant improvement in the care of patients with MBC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Female with HER2-positive disease
- 18 years of age or older
- ECOG greater or equal to 2
- Life expectancy greater or equal to 6 months
- Able to complete self administered quality of life evaluations and neurocognitive testing
Key exclusion criteria (7 listed)
- Current malignancy in the brain, as determined by screening MRI/CT done no more then 6 weeks prior to study treatment with PCI
- Chemo or radiation planned during the period when patients will receive study treatment with PCI
- Prior radiotherapy of the brain
- Prior stroke or brain hemorrhage in the 6 months prior to screening
- History of neurological/psychiatric disorders, including psychotic disorders or demential, or any other reason, which may affect neurocognitive assessment
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 |
|---|---|---|
| Prophylactic Cranial IrradiationProphylactic Cranial Irradiation | Radiation | – |
Primary outcome
To evaluate the safety of PCI, specifically with respect to neurocognitive function in patients with HER-2-positive metastatic breast cancer.
Time frame: approximately 2 to 3 years from study start
1 secondary outcome
To assess the impact of PCI on measures of survival, specifically brain metastases-free survival, overall progression free survival and overall survival
Time frame: approximately 4 years from study start
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Prophylactic Cranial Irradiation in people with Breast Cancer, run by Alberta Health services at 1 site in Canada.
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 8 inclusion and 7 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: finished, as of the sponsor's last update on 8 Aug 2011. 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 Canada. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the safety of PCI, specifically with respect to neurocognitive function in patients with HER-2-positive metastatic breast cancer. (time frame: approximately 2 to 3 years from study start). 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 8 Aug 2011.