A Prospective Cohort Study Evaluating Risk of Local Recurrence Following Breast Conserving Surgery and Endocrine Therapy in Low Risk Luminal A Breast Cancer (LUMINA)
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|ClinicalTrials.gov Identifier: NCT01791829|
Recruitment Status : Active, not recruiting
First Posted : February 15, 2013
Last Update Posted : August 19, 2019
|Condition or disease|
The independent prognostic ability of the luminal A subtype has been demonstrated in two retrospective analyses of prospective trials and suggests that luminal A combined with other known clinical prognostic factors could be used to select patients treated with BCS at very low risk for IBTR who could avoid BI. Given that using intrinsic subtyping combined with other clinical factors to identify women who could avoid BI would be a major change in clinical practice, we propose that a prospective study is necessary to confirm that such an approach can accurately identify a group of women at very low risk for IBTR following BCS.
We anticipate that the risk of IBTR in the low risk group is likely to be lower than that observed in previous trials (predicted to be < 5% at 5 years and < 10% at 10 years) for several reasons: first, our selection criteria (node negative, luminal A, > or = 55 years, tumours < or = 2cm, excision margin > or = 1mm post-BCS, absence of lobular cancers, extensive intraductal component and lymphovascular invasion) are more restrictive than in previous trials and second, the risks of IBTR are steadily decreasing over time due to improvements in mammographic screening, pre-op staging, tumour localization, and surgical practice. The expected low failure rates are unlikely to warrant the use of radiation.
A prospective cohort study was identified as the most appropriate and efficient design as our primary hypothesis is that a group of patients at very low risk of IBTR can be identified. A randomized trial could address the effectiveness of radiation in such a cohort of patients, but would require a much larger sample size to detect very small differences, which would not be clinically meaningful. During the conduct of this trial it is anticipated that patients who do not meet study criteria or who decline study enrollment, will continue to receive BI after BCS.
|Study Type :||Observational|
|Actual Enrollment :||500 participants|
|Official Title:||A Prospective Cohort Study Evaluating Risk of Local Recurrence Following Breast Conserving Surgery and Endocrine Therapy in Low Risk Luminal A Breast Cancer|
|Study Start Date :||July 2013|
|Estimated Primary Completion Date :||March 2023|
|Estimated Study Completion Date :||July 2023|
Luminal A with other Clinical Criteria
BCS postulated to be at low risk for IBTR following Endocrine Therapy
- Ipsilateral Breast Tumour Recurrence (IBTR) [ Time Frame: 5 years ]The primary outcome is IBTR defined as recurrent invasive or in-situ cancer in the ipsilateral breast during follow-up. Histological evidence of recurrence will be required. All recurrences will be reviewed by a central adjudication committee.
- Recurrence Free interval (RFI) [ Time Frame: 5 years ]Recurrence free interval (RFI) defined as time from registration to time of documented recurrent disease (ipsilateral breast, regional or distant)
- Event-free survival (EFS) [ Time Frame: 5 years ]Event-free survival (EFS) defined as the time from registration to the time of documented IBTR, regional (ipsilateral axilla, supraclavicular or internal mammary nodes), distant recurrence (bone, liver, lung, brain, etc.), contralateral breast cancer, new primary cancer or death
- Overall survival (OS) [ Time Frame: 5 years ]Overall survival (OS) defined as time from registration to death of any cause
Biospecimen Retention: Samples With DNA
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01791829
|Principal Investigator:||Tim Whelan, MD||Ontario Clinical Oncology Group (OCOG)|
|Principal Investigator:||Sally Smith, MD||British Columbia Cancer Agency (BCCA)|