Breast CancerLUMINANCT01791829
A Prospective Cohort Study Evaluating Risk of Local Recurrence Following Breast Conserving Surgery and Endocrine Therapy in Low Risk Luminal A Breast Cancer
An observational study of Breast Cancer, run by Ontario Clinical Oncology Group (OCOG) at 27 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 years and older, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 500 participants
- Where
- 27 sitesCanada
- Study dates
- Jul 2013to Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 55 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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;
- ER positive (> or =1%) and PR positive (>20%) and HER2 negative (Immunohistochemical (IHC) or In Situ Hybridization (ISH) approach);
- Treated by BCS with microscopically clear resection margins > or = 1mm for invasive and non-invasive disease or no residual disease on re-excision;
- Negative axillary node involvement determined by sentinel node biopsy or axillary node dissection.
Who cannot join
- Clinical or pathological evidence of T4 disease (i.e. extension to chest wall, skin involvement, peau d'orange, or inflammatory breast cancer).
- Multifocal or multicentric disease.
- 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.
- Grade 3 histology for invasive disease
- Evidence of lymphovascular invasion.
- Evidence of disease on pre-operative mammogram, aside from primary cancer treated by breast conserving surgery.
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- Bilateral malignancy of the breast (synchronous or metachronous).
- Known BRCA 1 or 2 mutations.
- 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.
- Serious non-malignant disease associated with a life expectancy < 10 years.
- Inability to be treated with or to tolerate endocrine therapy.
- Psychiatric or addictive disorder, which would preclude obtaining informed consent or adherence to protocol.
- Geographic inaccessibility for follow-up.
- Inability to understand or unable to provide written informed consent.
- Inability to be registered on study within 12 weeks of the last surgical procedure on the breast.
- Central testing for Ki67 > 13.25% consistent with the luminal B subtype
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
Canada27 sites
Abbotsford Centre
Abbotsford British Columbia, British Columbia, V2S 0C2
Royal Victoria Regional Health Centre
Barrie, Ontario, L4M 6M2
Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2
Northeastern Ontario Regional Cancer Centre
Greater Sudbury, Ontario, P3E 5J1
Juravinski Cancer Centre
Hamilton, Ontario, L8V 1C3
Cancer Centre of Southern Ontario at Kingston
Kingston, Ontario
Grand River Regional Cancer Centre
Kitchener, Ontario, N2G 1G3
Centre integre de sante et de services sociaux de laval (CISSS de Laval)
Laval, Quebec, H7M 3L9
London Regional Cancer Centre
London, Ontario, N6A 4L6
CHUM - Hopital Notre Dame
Montreal, Quebec, H2L 4M1
The Jewish General Hospital
Montreal, Quebec, H3T1E2
McGill University Health Centre
Montreal, Quebec, H4A 3J1
R.S. McLaughlin Durham Regional Cancer Centre
Oshawa, Ontario, L1G 2B9
Ottawa Regional Cancer Centre
Ottawa, Ontario, K1H 8L6
BC Cancer Agency, Centre for the North
Prince George, British Columbia, V2M 7E9
CHUQ - Pavillon Hotel-Dieu de Quebec
Québec, Quebec, G1R 2J6
The Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, S7N 4H4
Algoma District Cancer Program
Sault Ste. Marie, Ontario, P6B 0A8
CHUS - Hopital Fleurimont
Sherbrooke, Quebec, J1H 5N4
Niagara Health System
St. Catharines, Ontario, L2S 0A9
Thunder Bay Regional Health Sciences
Thunder Bay, Ontario, P7B 6V4
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 1Z6
BCCA - Vancouver Centre
Vancouver, British Columbia, V5Z 4E6
BC Cancer Agency
Victoria, British Columbia, V9R 6V5
Cancer Care Manitoba
Winnipeg, Manitoba, R3E 0V9
About this study
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.
Read the 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.
- Conditions
- Breast Cancer
- Keywords
- Luminal A, Ipsilateral Breast Tumour Recurrence
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Luminal A with other Clinical Criteria | BCS postulated to be at low risk for IBTR following Endocrine Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ipsilateral Breast Tumour Recurrence (IBTR)
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.
Measured: 5 years
Secondary outcomes (3)
Recurrence Free interval (RFI)
Recurrence free interval (RFI) defined as time from registration to time of documented recurrent disease (ipsilateral breast, regional or distant)
Measured: 5 years
Event-free survival (EFS)
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
Measured: 5 years
Overall survival (OS)
Overall survival (OS) defined as time from registration to death of any cause
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2013 (estimated)
- Study startJul 2013
- Primary completionMar 2023
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ontario Clinical Oncology Group (OCOG)
- Sponsor type
- University, hospital or other
- Collaborators
- British Columbia Cancer Agency, McMaster University
- Responsible party
- Sponsor
- Investigators
- Tim Whelan, MD, Principal investigator, Ontario Clinical Oncology Group (OCOG)Sally Smith, MD, Principal investigator, British Columbia Cancer Agency (BCCA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01791829
- Sponsor's protocol ID
- OCOG-2012-LUMINA
- Acronym
- LUMINA
- Status last verified
- Aug 2023
- First submitted
- 12 Feb 2013
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Nielsen TO, Leung SCY, Riaz N, Mulligan AM, Kos Z, Bane A, Whelan TJ. Ki67 assessment protocol as an integral biomarker for avoiding radiotherapy in the LUMINA breast cancer trial. Histopathology. 2023 Dec;83(6):903-911. doi: 10.1111/his.15032. Epub 2023 Aug 23.
PubMed 37609778Whelan TJ, Smith S, Parpia S, Fyles AW, Bane A, Liu FF, Rakovitch E, Chang L, Stevens C, Bowen J, Provencher S, Theberge V, Mulligan AM, Kos Z, Akra MA, Voduc KD, Hijal T, Dayes IS, Pond G, Wright JR, Nielsen TO, Levine MN; LUMINA Study Investigators. Omitting Radiotherapy after Breast-Conserving Surgery in Luminal A Breast Cancer. N Engl J Med. 2023 Aug 17;389(7):612-619. doi: 10.1056/NEJMoa2302344.
PubMed 37585627
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01791829
- Acronym / sponsor ID
- LUMINA / OCOG-2012-LUMINA
- Conditions
- Breast Cancer
- Keywords
- Luminal A, Ipsilateral Breast Tumour Recurrence
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Ontario Clinical Oncology Group (OCOG)University, hospital or other
- Collaborators
- British Columbia Cancer Agency, McMaster University
- Study start
- Jul 2013 (actual)
- Primary completion
- Mar 2023 (actual)
- Study completion
- Jul 2027 (estimated)
- First posted
- 15 Feb 2013 (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.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Luminal A with other Clinical Criteria | – | –BCS postulated to be at low risk for IBTR following Endocrine Therapy |
Who may qualify
- Ages
- 55 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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;
- ER positive (> or =1%) and PR positive (>20%) and HER2 negative (Immunohistochemical (IHC) or In Situ Hybridization (ISH) approach);
- Treated by BCS with microscopically clear resection margins > or = 1mm for invasive and non-invasive disease or no residual disease on re-excision;
- Negative axillary node involvement determined by sentinel node biopsy or axillary node dissection.
Key exclusion criteria (16 listed)
- Clinical or pathological evidence of T4 disease (i.e. extension to chest wall, skin involvement, peau d'orange, or inflammatory breast cancer).
- Multifocal or multicentric disease.
- 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.
- Grade 3 histology for invasive disease
- Evidence of lymphovascular invasion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
Recurrence Free interval (RFI)
Time frame: 5 years
Event-free survival (EFS)
Time frame: 5 years
Overall survival (OS)
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Derived from this study: PubMed 37609778Nielsen TO, Leung SCY, Riaz N, Mulligan AM, Kos Z, Bane A, Whelan TJ. Ki67 assessment protocol as an integral biomarker for avoiding radiotherapy in the LUMINA breast cancer trial. Histopathology. 2023 Dec;83(6):903-911. doi: 10.1111/his.15032. Epub 2023 Aug 23.
- Derived from this study: PubMed 37585627Whelan TJ, Smith S, Parpia S, Fyles AW, Bane A, Liu FF, Rakovitch E, Chang L, Stevens C, Bowen J, Provencher S, Theberge V, Mulligan AM, Kos Z, Akra MA, Voduc KD, Hijal T, Dayes IS, Pond G, Wright JR, Nielsen TO, Levine MN; LUMINA Study Investigators. Omitting Radiotherapy after Breast-Conserving Surgery in Luminal A Breast Cancer. N Engl J Med. 2023 Aug 17;389(7):612-619. doi: 10.1056/NEJMoa2302344.
- Related InfoLink provided by the sponsor.
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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.
Tim Whelan, MD principal investigator
Ontario Clinical Oncology Group (OCOG)
Sally Smith, MD principal investigator
British Columbia Cancer Agency (BCCA)
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Ontario Clinical Oncology Group (OCOG) at 27 sites 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 4 inclusion and 16 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: under way, not looking for participants, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Ipsilateral Breast Tumour Recurrence (IBTR) (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01791829, which also lists 2 linked publications.
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 17 Jun 2026.