Radiation-Free path for Low-Risk breast cancer? new study tests safety
NCT ID NCT01791829
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is testing whether women over 55 with a specific low-risk type of breast cancer (luminal A) can avoid radiation after lumpectomy. Instead, they take hormone-blocking pills for 5 years. Researchers are tracking 500 women for 10 years to see how many have the cancer come back in the same breast. The goal is to find a less intense treatment that still keeps the cancer under control.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
-
500 people
The number who actually took part.
- Started
-
Jul 2013
- Expected to finish
-
Jul 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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
- Ages
-
55 years and older
- Sex
-
Female participants only
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Breast cancer are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Abbotsford Centre
Abbotsford British Columbia, British Columbia, V2S 0C2, Canada
-
Algoma District Cancer Program
Sault Ste. Marie, Ontario, P6B 0A8, Canada
-
BC Cancer Agency
Victoria, British Columbia, V9R 6V5, Canada
-
BC Cancer Agency, Centre for the North
Prince George, British Columbia, V2M 7E9, Canada
-
BCCA - Vancouver Centre
Vancouver, British Columbia, V5Z 4E6, Canada
-
CHUM - Hopital Notre Dame
Montreal, Quebec, H2L 4M1, Canada
-
CHUQ - Pavillon Hotel-Dieu de Quebec
Québec, Quebec, G1R 2J6, Canada
-
CHUS - Hopital Fleurimont
Sherbrooke, Quebec, J1H 5N4, Canada
-
Cancer Care Manitoba
Winnipeg, Manitoba, R3E 0V9, Canada
-
Cancer Centre of Southern Ontario at Kingston
Kingston, Ontario, Canada
-
Centre integre de sante et de services sociaux de laval (CISSS de Laval)
Laval, Quebec, H7M 3L9, Canada
-
Grand River Regional Cancer Centre
Kitchener, Ontario, N2G 1G3, Canada
-
Juravinski Cancer Centre
Hamilton, Ontario, L8V 1C3, Canada
-
London Regional Cancer Centre
London, Ontario, N6A 4L6, Canada
-
McGill University Health Centre
Montreal, Quebec, H4A 3J1, Canada
-
Niagara Health System
St. Catharines, Ontario, L2S 0A9, Canada
-
Northeastern Ontario Regional Cancer Centre
Greater Sudbury, Ontario, P3E 5J1, Canada
-
Ottawa Regional Cancer Centre
Ottawa, Ontario, K1H 8L6, Canada
-
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 1Z6, Canada
-
R.S. McLaughlin Durham Regional Cancer Centre
Oshawa, Ontario, L1G 2B9, Canada
-
Royal Victoria Regional Health Centre
Barrie, Ontario, L4M 6M2, Canada
-
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, S7N 4H4, Canada
-
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5, Canada
-
The Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1, Canada
-
The Jewish General Hospital
Montreal, Quebec, H3T1E2, Canada
-
Thunder Bay Regional Health Sciences
Thunder Bay, Ontario, P7B 6V4, Canada
-
Tom Baker Cancer Centre
Calgary, Alberta, T2N 4N2, Canada
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a common steroid shield breast cancer patients from a dangerous drug side effect?
- Tiny magnetic seeds could guide surgeons to the right lymph node
- New PET tracer aims to light up hidden cancer targets
- Gut bacteria supplement tested against chemo hair loss
- Can a mindfulness program boost Self-Compassion in breast cancer survivors?
- Can a Decades-Old Anti-Inflammatory drug quiet the joint pain that drives women off breast cancer therapy?