Clinical trial · Observational
A Prospective Cohort Study Evaluating Risk of Local Recurrence Following Breast Conserving Surgery and Endocrine Therapy in Low Risk Luminal A Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Luminal A with other Clinical Criteria
- description
- BCS postulated to be at low risk for IBTR following Endocrine Therapy
Primary outcomes (1)
- measure
- Ipsilateral Breast Tumour Recurrence (IBTR)
- timeFrame
- 5 years
- description
- 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 outcomes (3)
- measure
- Recurrence Free interval (RFI)
- timeFrame
- 5 years
- description
- Recurrence free interval (RFI) defined as time from registration to time of documented recurrent disease (ipsilateral breast, regional or distant)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 55 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDNielsen 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
- DERIVEDWhelan 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