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

NCT01791829 | Active Not Recruiting DMC

• 1 other identifier: OCOG-2012-LUMINA
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 27

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.

Conditions

Breast Cancer

Keywords

Luminal A; Ipsilateral Breast Tumour Recurrence

Outcome Measures

Primary Outcomes (1)

• 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.

  5 years

Secondary Outcomes (3)

• Recurrence Free interval (RFI)

  5 years

• Event-free survival (EFS)

  5 years

• Overall survival (OS)

  5 years

Study Arms (1)

Luminal A with other Clinical Criteria

BCS postulated to be at low risk for IBTR following Endocrine Therapy

Eligibility Criteria

• Age: 55 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Ontario Clinical Oncology Group (OCOG): lead
• British Columbia Cancer Agency: collaborator

Study Sites (27)

Tom Baker Cancer Centre

Calgary, Alberta, T2N 4N2, Canada

Location

Abbotsford Centre

Abbotsford, British Columbia, V2S 0C2, Canada

Location

BC Cancer Agency, Centre for the North

Prince George, British Columbia, V2M 7E9, Canada

Location

BCCA - Vancouver Centre

Vancouver, British Columbia, V5Z 4E6, Canada

Location

BC Cancer Agency

Victoria, British Columbia, V9R 6V5, Canada

Location

Cancer Care Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

Location

Royal Victoria Regional Health Centre

Barrie, Ontario, L4M 6M2, Canada

Location

Northeastern Ontario Regional Cancer Centre

Greater Sudbury, Ontario, P3E 5J1, Canada

Location

Juravinski Cancer Centre

Hamilton, Ontario, L8V 1C3, Canada

Location

Cancer Centre of Southern Ontario at Kingston

Kingston, Ontario, Canada

Location

Grand River Regional Cancer Centre

Kitchener, Ontario, N2G 1G3, Canada

Location

London Regional Cancer Centre

London, Ontario, N6A 4L6, Canada

Location

R.S. McLaughlin Durham Regional Cancer Centre

Oshawa, Ontario, L1G 2B9, Canada

Location

Ottawa Regional Cancer Centre

Ottawa, Ontario, K1H 8L6, Canada

Location

Algoma District Cancer Program

Sault Ste. Marie, Ontario, P6B 0A8, Canada

Location

Niagara Health System

St. Catharines, Ontario, L2S 0A9, Canada

Location

Thunder Bay Regional Health Sciences

Thunder Bay, Ontario, P7B 6V4, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 1Z6, Canada

Location

Centre integre de sante et de services sociaux de laval (CISSS de Laval)

Laval, Quebec, H7M 3L9, Canada

Location

CHUM - Hopital Notre Dame

Montreal, Quebec, H2L 4M1, Canada

Location

The Jewish General Hospital

Montreal, Quebec, H3T1E2, Canada

Location

McGill University Health Centre

Montreal, Quebec, H4A 3J1, Canada

Location

CHUQ - Pavillon Hotel-Dieu de Quebec

Québec, Quebec, G1R 2J6, Canada

Location

CHUS - Hopital Fleurimont

Sherbrooke, Quebec, J1H 5N4, Canada

Location

The Allan Blair Cancer Centre

Regina, Saskatchewan, S4T 7T1, Canada

Location

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, S7N 4H4, Canada

Location

Related Publications (2)

• 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.

  PMID: 37609778 DERIVED

• Whelan 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.

  PMID: 37585627 DERIVED

Related Links

• Related Info

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Tim Whelan, MD

  Ontario Clinical Oncology Group (OCOG)

  PRINCIPAL INVESTIGATOR

• Sally Smith, MD

  British Columbia Cancer Agency (BCCA)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2013
• First Posted: February 15, 2013
• Study Start: July 1, 2013
• Primary Completion: March 1, 2023
• Study Completion (Estimated): July 1, 2027
• Last Updated: August 3, 2025

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (27)