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A Prospective Cohort Study Evaluating Risk of Local Recurrence Following Breast Conserving Surgery and Endocrine Therapy in Low Risk Luminal A Breast Cancer (LUMINA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01791829
Recruitment Status : Active, not recruiting
First Posted : February 15, 2013
Last Update Posted : August 19, 2019
Sponsor:
Collaborator:
British Columbia Cancer Agency
Information provided by (Responsible Party):
Ontario Clinical Oncology Group (OCOG)

Brief Summary:
This is a multicentre, single-arm prospective cohort study evaluating risk of ipsilateral breast tumour recurrence(IBTR) following breast conserving surgery (BCS) in a group of women postulated to be at low risk for recurrence. Women with luminal A breast cancer determined by immunohistochemical(IHC) and other low risk clinical testing (see below) will be treated with endocrine therapy (tamoxifen or aromatase inhibitor) for five years and will not be treated with breast irradiation (BI). Subjects will be followed for 10 years and will be assessed for recurrent disease, new primary cancer and survival.

Condition or disease
Breast Cancer

Detailed Description:

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.

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Study Type : Observational
Actual Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Group/Cohort
Luminal A with other Clinical Criteria
BCS postulated to be at low risk for IBTR following Endocrine Therapy



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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)

  2. 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

  3. 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
Specimens will be used to determine Ki67 status by IHC and subsequent testing for DNA/RNA.


Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
This is a multicentre, single-arm prospective cohort study evaluating risk of IBTR following BCS in a group of women postulated to be at low risk for recurrence. Subjects will be followed for 10 years and will be assessed for recurrent disease, new primary cancer and survival. The primary outcome is IBTR
Criteria

Inclusion Criteria:

  1. Female patient > or = 55 years of age with a new diagnosis of invasive carcinoma of the breast (ductal, tubular or mucinous only) with primary tumour < or =2cm on microscopic exam, with no evidence of metastatic disease;
  2. ER positive (> or =1%) and PR positive (>20%) and HER2 negative (Immunohistochemical (IHC) or In Situ Hybridization (ISH) approach);
  3. Treated by BCS with microscopically clear resection margins > or = 1mm for invasive and non-invasive disease or no residual disease on re-excision;
  4. Negative axillary node involvement determined by sentinel node biopsy or axillary node dissection.

Exclusion Criteria:

  1. Clinical or pathological evidence of T4 disease (i.e. extension to chest wall, skin involvement, peau d'orange, or inflammatory breast cancer).
  2. Multifocal or multicentric disease.
  3. Evidence of an extensive intraductal component (defined as a tumour that is composed of 25% or more of DCIS and the DCIS extends beyond the gross dimensions of the tumour), or disease limited to micro invasion only.
  4. Grade 3 histology for invasive disease
  5. Evidence of lymphovascular invasion.
  6. Evidence of disease on pre-operative mammogram, aside from primary cancer treated by breast conserving surgery.
  7. Bilateral malignancy of the breast (synchronous or metachronous).
  8. Known BRCA 1 or 2 mutations.
  9. History of non-breast cancer malignancies if not disease free for > 5 years and considered low risk of recurrence with the exception of treated carcinoma in-situ of the cervix, endometrium or colon, melanoma in-situ and basal or squamous cell carcinoma of the skin.
  10. Serious non-malignant disease associated with a life expectancy < 10 years.
  11. Inability to be treated with or to tolerate endocrine therapy.
  12. Psychiatric or addictive disorder, which would preclude obtaining informed consent or adherence to protocol.
  13. Geographic inaccessibility for follow-up.
  14. Inability to understand or unable to provide written informed consent.
  15. Inability to be registered on study within 12 weeks of the last surgical procedure on the breast.
  16. Central testing for Ki67 > 13.25% consistent with the luminal B subtype

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01791829


Locations
Show Show 27 study locations
Sponsors and Collaborators
Ontario Clinical Oncology Group (OCOG)
British Columbia Cancer Agency
Investigators
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Principal Investigator: Tim Whelan, MD Ontario Clinical Oncology Group (OCOG)
Principal Investigator: Sally Smith, MD British Columbia Cancer Agency (BCCA)

Additional Information:
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Responsible Party: Ontario Clinical Oncology Group (OCOG)
ClinicalTrials.gov Identifier: NCT01791829    
Other Study ID Numbers: OCOG-2012-LUMINA
First Posted: February 15, 2013    Key Record Dates
Last Update Posted: August 19, 2019
Last Verified: August 2018
Keywords provided by Ontario Clinical Oncology Group (OCOG):
Luminal A
Ipsilateral Breast Tumour Recurrence
Additional relevant MeSH terms:
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Breast Neoplasms
Recurrence
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Disease Attributes
Pathologic Processes
Phenobarbital
Anticonvulsants
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
GABA Modulators
GABA Agents
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP3A Inducers