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Radiation-Free path for Low-Risk breast cancer? new study tests safety

NCT ID NCT01791829

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

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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

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