Breast CancerPhase 3NCT00966888
Radiation Therapy or Standard Therapy in Treating Women With Stage II Breast Cancer Who Have Undergone Mastectomy
A Phase 3 study testing standard follow-up care and radiation therapy in people with Breast Cancer, run by Medical Research Council at 2 sites in United Kingdom.
Trial summary
RATIONALE: Radiation therapy uses high-energy x-rays or other types of radiation to kill tumor cells. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- standard follow-up care and radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,500 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Jan 2006to Jun 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed unilateral invasive breast cancer
- pT1, pN1, M0 disease
- pT2, pN1, M0 disease
- pT2, pN0 disease with grade III histology and/or lymphovascular invasion
- Multifocal breast cancer meeting both of the following criteria:
- Largest discrete tumor ≥ 2 cm if N0
- Grade III histology and/or lymphovascular invasion
- No bilateral breast cancer
- Axillary node negative status by axillary clearance, axillary node sampling, or sentinel node biopsy
- Patients with axillary node positive (1-3 positive nodes, including micrometastases* > 0.2 mm and ≤ 2 mm) must have had an axillary node clearance (minimum of 10 nodes removed) performed
- No more than 3 pathologically involved lymph nodes
- No internal mammary nodes visible on sentinel node scintigraphy in the absence of negative histology NOTE: *Isolated tumor cells not counted as micrometastases
- Underwent total mastectomy (with minimum of 1 mm margin clear of invasive cancer and DCIS) and axillary surgery with staging procedure
- Must have undergone adjuvant systemic chemotherapy if indicated for intermediate-risk breast cancer
- Patients undergoing immediate breast reconstruction allowed
- No known BRCA1 and BRCA2 carriers
- Hormone receptor status not specified
PATIENT CHARACTERISTICS:
- Menopausal status not specified
- Not pregnant
- Fit for adjuvant chemotherapy, adjuvant endocrine therapy, and post-operative radiotherapy
- No prior or concurrent malignancy except curatively treated nonmelanomatous skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No concurrent trastuzumab
- No prior neoadjuvant systemic therapy
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites, 2 recruiting
- Recruiting
Edinburgh Cancer Centre at Western General Hospital
Edinburgh, Scotland, EH4 2XU
Ian H. Kunkler, MD, 44-131-537-2214, i.kunkler@ed.ac.uk
- Recruiting
Royal Infirmary - Castle
Glasgow, Scotland, G4 0SF
Peter A. Canney, MD, 44-141-211-1160
About this study
Official title: Selective Use of Postoperative Radiotherapy AftEr MastectOmy - SUPREMO
RATIONALE: Radiation therapy uses high-energy x-rays or other types of radiation to kill tumor cells. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether radiation therapy is more effective than observation after mastectomy in treating women with stage II breast cancer.
PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared with standard therapy in treating women with stage II breast cancer who have undergone mastectomy.
Read the detailed description
OBJECTIVES:
- Determine the overall survival of women at intermediate risk for locoregional recurrence of breast cancer treated with ipsilateral chest wall adjuvant radiotherapy after mastectomy.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Beginning 12 weeks after mastectomy or 6 weeks after adjuvant chemotherapy, patients undergo radiotherapy 5 days a week for 3-5 weeks in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive standard of care and observation only. After completion of study therapy, patients are followed up twice in the first year, and then annually for up to 10 years.
- Conditions
- Breast Cancer
- Being tested
- standard follow-up care, radiation therapy
- Keywords
- stage II 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.
standard follow-up careProcedure or surgery
No intervention
radiation therapyRadiation
Chest wall radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Beginning 12 weeks after mastectomy or 6 weeks after adjuvant chemotherapy, patients undergo radiotherapy 5 days a week for 3-5 weeks in the absence of disease progression or unacceptable toxicity. Receives: Radiation: radiation therapy |
| Arm II | Active comparator | Patients receive standard of care and observation only. Receives: Procedure: standard follow-up care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Acute and late morbidity
Secondary outcomes (7)
Chest wall recurrence
Regional recurrence
Disease-free survival
Metastasis-free survival
Cause of death (breast cancer, or intercurrent disease [cardiovascular or non-cardiovascular])
Quality of life
Cost effectiveness
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2009 (estimated)
- Study startJan 2006
- Primary completionJun 2010 (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.
- 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
- Treatment
- Allocation
- Randomised
- Enrolment
- 3,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical Research Council
- Sponsor type
- Other government
- Investigators
- Ian H. Kunkler, MD, Principal investigator, Edinburgh Cancer Centre at Western General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00966888
- Sponsor's protocol ID
- MRC-BIG2-04
- Other IDs
- CDR0000642751, ISRCTN61145589, EU-20943
- Status last verified
- Aug 2009
- First submitted
- 26 Aug 2009
- Last updated
- 12 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selective Use of Postoperative Radiotherapy AftEr MastectOmy - SUPREMO
- ClinicalTrials.gov ID
- NCT00966888
- Acronym / sponsor ID
- MRC-BIG2-04
- Conditions
- Breast Cancer
- Keywords
- stage II breast cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,500 participants (estimated)
- Lead sponsor
- Medical Research CouncilOther government
- Study start
- Jan 2006
- Primary completion
- Jun 2010 (estimated)
- First posted
- 27 Aug 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.
RATIONALE: Radiation therapy uses high-energy x-rays or other types of radiation to kill tumor cells. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether radiation therapy is more effective than observation after mastectomy in treating women with stage II breast cancer.
PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared with standard therapy in treating women with stage II breast cancer who have undergone mastectomy.
Detailed description
OBJECTIVES:
- Determine the overall survival of women at intermediate risk for locoregional recurrence of breast cancer treated with ipsilateral chest wall adjuvant radiotherapy after mastectomy.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Beginning 12 weeks after mastectomy or 6 weeks after adjuvant chemotherapy, patients undergo radiotherapy 5 days a week for 3-5 weeks in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive standard of care and observation only. After completion of study therapy, patients are followed up twice in the first year, and then annually for up to 10 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Radiation: radiation therapyBeginning 12 weeks after mastectomy or 6 weeks after adjuvant chemotherapy, patients undergo radiotherapy 5 days a week for 3-5 weeks in the absence of disease progression or unacceptable toxicity. |
| Arm II | Active comparator | Procedure: standard follow-up carePatients receive standard of care and observation only. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, 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 |
|---|---|---|
| standard follow-up careNo intervention | Procedure or surgery | Arm II |
| radiation therapyChest wall radiotherapy | Radiation | Arm I |
Primary outcome
Overall survival
Acute and late morbidity
7 secondary outcomes
Chest wall recurrence
Regional recurrence
Disease-free survival
Metastasis-free survival
Cause of death (breast cancer, or intercurrent disease [cardiovascular or non-cardiovascular])
Quality of life
Cost effectiveness
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2013.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Edinburgh Cancer Centre at Western General Hospital
Edinburgh, United Kingdom
Ian H. Kunkler, MD principal investigator
Edinburgh Cancer Centre at Western General Hospital
2 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 standard follow-up care and radiation therapy in people with Breast Cancer, run by Medical Research Council at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 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 2 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival. The study lists 2 primary outcomes in all. 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 12 Aug 2013.