Breast CancerPhase 3NCT00639366
Radiation Therapy to the Head in Preventing Brain Metastases in Women Receiving Trastuzumab and Chemotherapy for Metastatic or Locally Advanced Breast Cancer
A Phase 3 study testing trastuzumab, chemotherapy and radiation therapy in people with Breast Cancer, run by Anglo Celtic Cooperative Oncology Group at 19 sites in United Kingdom.
Trial summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether radiation therapy directed at the head is effective in preventing brain metastases in patients with advanced cancer. 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?
- trastuzumab, chemotherapy and radiation therapy
- Type of treatment
- Surgery or procedure
- How many people
- 390 participants
- Where
- 19 sitesUnited Kingdom
- Study dates
- Feb 2007to Oct 2010
- Phase
- Phase 3
- 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
DISEASE CHARACTERISTICS:
- Histologically proven breast carcinoma
- Metastatic or locally advanced disease
- Must demonstrate HER2 3+ positivity on IHC or 2+ over-expression and FISH test demonstrating C-erB2 gene amplification
- No known or suspected brain metastases or CNS disease, as defined by the presence of any of the following key symptoms:
- Headache
- Nausea and/or vomiting
- Clinical signs of raised intracranial pressure
- Seizures
- Focal symptoms
- Cognitive dysfunction
- Affective disorder
- Hormone receptor status not specified
PATIENT CHARACTERISTICS:
- Female
- Postmenopausal status not specified
- ECOG performance status 0 or 1
- Patients must a-priori be suitable for trastuzumab (Herceptin®) +/- chemotherapy in terms of bone marrow, hepatic, and renal function
- No prior history of cerebrovascular disease or neurological disorder including seizures
PRIOR CONCURRENT THERAPY:
- No prior cranial radiotherapy
- No prior neurosurgery
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United Kingdom19 sites
Basildon University Hospital
Basildon, England, SS16 5NL
Dumfries & Galloway Royal Infirmary
Dumfries, Scotland, DG1 4AP
Ninewells Hospital
Dundee, Scotland, DD1 9SY
Edinburgh Cancer Centre at Western General Hospital
Edinburgh, Scotland, EH4 2XU
Falkirk and District Royal Infirmary
Falkirk, Scotland, FK1 5QE
Beatson West of Scotland Cancer Centre
Glasgow, Scotland, G12 0YN
Ipswich Hospital
Ipswich, England, IP4 5PD
Crosshouse Hospital
Kilmarnock, Scotland, KA2 OBE
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, LS9 7TF
Royal Liverpool University Hospital
Liverpool, England, L7 8XP
Aintree University Hospital
Liverpool, England, L9 7AL
Barts and the London School of Medicine
London, England, EC1M 6BQ
Christie Hospital
Manchester, England, M20 4BX
Clatterbridge Centre for Oncology
Merseyside, England, CH63 4JY
Cancer Research Centre at Weston Park Hospital
Sheffield, England, S1O 2SJ
Great Western Hospital
Swindon, England, SN3 6BB
Southend University Hospital NHS Foundation Trust
Westcliff-on-Sea, England, SS0 0RY
Wishaw General Hospital
Wishaw, Scotland, ML2 0DP
Cancer Care Centre at York Hospital
York, England, Y031 8HE
About this study
Official title: Prospective Randomised Clinical Trial Testing the Role of Prophylactic Cranial Radiotherapy in Patients Treated With Trastuzumab (Herceptin®) for Metastatic Breast Cancer
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether radiation therapy directed at the head is effective in preventing brain metastases in patients with advanced cancer.
PURPOSE: This randomized phase III trial is studying radiation therapy to the head to see how well it works in preventing brain metastases in women receiving trastuzumab and chemotherapy for metastatic or locally advanced breast cancer.
Read the detailed description
OBJECTIVES:
- To test if prophylactic cranial radiotherapy delivering 30 Gy in 10 fractions will significantly reduce (from 35% to 21% at 2 years) the incidence of symptomatic brain metastases in patients treated with trastuzumab (Herceptin®) for metastatic breast cancer.
OUTLINE: This is a multicenter study. Patients are stratified by center, type of systemic therapy (trastuzumab [Herceptin®] monotherapy vs combination with chemotherapy), hormone receptor status, and presence of lung metastases (yes vs no). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive taxane/trastuzumab therapy for 6 weeks. While continuing taxane/trastuzumab therapy, patients then undergo 10 fractions of concurrent prophylactic cranial radiotherapy in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive taxane/trastuzumab therapy without concurrent prophylactic cranial radiotherapy.
All patients undergo quality of life assessments every 8 weeks for 9 months.
After completion of study treatment, patients are followed periodically for at least 1 year.
- Conditions
- Breast Cancer
- Being tested
- trastuzumab, chemotherapy, radiation therapy
- Keywords
- recurrent breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV 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.
trastuzumabBiological
chemotherapyDrug
radiation therapyRadiation
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of symptomatic brain metastases
Secondary outcomes (2)
Survival
Cerebral toxicity and quality of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2008 (estimated)
- Study startFeb 2007
- Primary completionFeb 2010
- Study completionOct 2010
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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Enrolment
- 390 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anglo Celtic Cooperative Oncology Group
- Sponsor type
- University, hospital or other
- Investigators
- Peter A. Canney, MD, Principal investigator, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00639366
- Sponsor's protocol ID
- ACCOG-HER-PCI
- Other IDs
- CDR0000588868, ISRCTN64624715, EU-20822
- Status last verified
- Dec 2008
- First submitted
- 19 Mar 2008
- Last updated
- 7 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomised Clinical Trial Testing the Role of Prophylactic Cranial Radiotherapy in Patients Treated With Trastuzumab (Herceptin®) for Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00639366
- Acronym / sponsor ID
- ACCOG-HER-PCI
- Conditions
- Breast Cancer
- Keywords
- recurrent breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 390 participants (estimated)
- Lead sponsor
- Anglo Celtic Cooperative Oncology GroupUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- Feb 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 20 Mar 2008 (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.
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether radiation therapy directed at the head is effective in preventing brain metastases in patients with advanced cancer.
PURPOSE: This randomized phase III trial is studying radiation therapy to the head to see how well it works in preventing brain metastases in women receiving trastuzumab and chemotherapy for metastatic or locally advanced breast cancer.
Detailed description
OBJECTIVES:
- To test if prophylactic cranial radiotherapy delivering 30 Gy in 10 fractions will significantly reduce (from 35% to 21% at 2 years) the incidence of symptomatic brain metastases in patients treated with trastuzumab (Herceptin®) for metastatic breast cancer.
OUTLINE: This is a multicenter study. Patients are stratified by center, type of systemic therapy (trastuzumab [Herceptin®] monotherapy vs combination with chemotherapy), hormone receptor status, and presence of lung metastases (yes vs no). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive taxane/trastuzumab therapy for 6 weeks. While continuing taxane/trastuzumab therapy, patients then undergo 10 fractions of concurrent prophylactic cranial radiotherapy in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive taxane/trastuzumab therapy without concurrent prophylactic cranial radiotherapy.
All patients undergo quality of life assessments every 8 weeks for 9 months.
After completion of study treatment, patients are followed periodically for at least 1 year.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| trastuzumab | Biological | – |
| chemotherapy | Drug | – |
| radiation therapy | Radiation | – |
Primary outcome
Incidence of symptomatic brain metastases
2 secondary outcomes
Survival
Cerebral toxicity and quality of life
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 7 Aug 2013.
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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.
Peter A. Canney, MD principal investigator
University of Glasgow
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing trastuzumab, chemotherapy and radiation therapy in people with Breast Cancer, run by Anglo Celtic Cooperative Oncology Group at 19 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 7 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United Kingdom. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Incidence of symptomatic brain metastases. 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 7 Aug 2013.