Skip to content

Hypofractionated LocoRegional Radiotherapy in Breast Cancer

Breast Neoplasms | Lymphedema | Radiotherapy

The primary objective of this study is to determine if hypofractionated RT delivered over 1 week to the breast or chest wall and regional nodes (26Gy in 5 daily fractions) following BCS or mastectomy, is non-inferior to conventional fractionation to the breast or chest wall and regional nodes delivered over 3 weeks (40Gy in 15 daily fractions) in patients with node-positive breast cancer.

null

Conditions de participation

  • Sexe:

    ALL

  • Âges admissibles:

    18 and up

Critères de participation

Inclusion Criteria:

1. Newly diagnosed invasive carcinoma of the breast.
2. Treated with definitive surgery (BCS or mastectomy with nodal staging using SLNB or ALND) with clear margins of excision.\* Note: \*Patients with limited positive posterior margin where disease is resected to chest wall or limited positive anterior margin where disease is resected to dermis are eligible.
3. Candidate for locoregional radiotherapy: breast cancer stage after definitive surgery:

* Neoadjuvant chemotherapy was not administered: pathologic stage T3N0,T1-3 N1-2\*\*

\*\* patients with nodal micromets (N1mi) are eligible
* Neoadjuvant chemotherapy was administered: clinical stage T3N0, T1-3, N1-2 and pathologic stage T0-3, N0-2†

* Patients who are clinically N1-2 prior to chemotherapy should be confirmed histologically unless it is clear that they are node positive. Patients who are deemed node negative prior to chemotherapy but are node positive following chemotherapy are eligible. Patients who are node positive prior to chemotherapy and who have complete response in the lymph nodes are also eligible.
4. No evidence of metastatic disease.

Exclusion Criteria:

1. Age \< 18 years.
2. Clinical stages T4 and/or N3.
3. Clinical lymphedema in the ipsilateral arm or breast/chest wall.
4. Any prior history, not including index cancer, of ipsilateral invasive breast cancer or ipsilateral DCIS treated with radiation therapy. (Patients with previous ipsilateral DCIS or LCIS not treated with radiation are eligible.)
5. Synchronous or previous contralateral breast cancer.(Patients with previous contralateral DCIS or LCIS not treated with radiation are eligible.)
6. History of non-breast malignancy within the last 5 years other than non-melanoma skin cancer or treated in-situ carcinoma.
7. Neoadjuvant endocrine therapy. (Extended neoadjuvant endocrine therapy is not permitted. Endocrine therapy exposure for 12 weeks or less prior to surgery is acceptable.)
8. Breast reconstruction.
9. Presence of known medical conditions that would preclude follow-up for 5 years.
10. Previous radiotherapy to the ipsilateral breast or chest wall or serious non-malignant disease e.g. scleroderma, severe lung or heart disease that would preclude radiotherapy.
11. Known pregnancy or currently lactating.
12. Geographic inaccessibility for follow-up.
13. Inability to provide informed consent.

Lieu de l'étude

Cross Cancer Institute
Cross Cancer Institute
Edmonton, Alberta
Canada

Contactez l'équipe d'étude

Primary Contact

Juliette Jordan

Backup Contact

Fleur Huang

BC Cancer - Vancouver Island Centre
BC Cancer - Vancouver Island Centre
Victoria, British Columbia
Canada

Contactez l'équipe d'étude

Backup Contact

Tanya Berrang

Primary Contact

Lily Hallett Rio

Northeast Cancer Centre, Health Sciences North
Northeast Cancer Centre, Health Sciences North
Sudbury, Ontario
Canada

Contactez l'équipe d'étude

Backup Contact

Jacqueline Lam

Primary Contact

Amanda Snyder

CIUSSS de l'Est-de-l'Île de Montréal, Hôpital, Maisonneuve-Rosemont
CIUSSS de l'Est-de-l'Île de Montréal, Hôpital, Maisonneuve-Rosemont
Montreal, Quebec
Canada

Contactez l'équipe d'étude

Backup Contact

Michael Yassa, MD

Primary Contact

Lys Fernet

Sherbrooke University Hospital Centre
Sherbrooke University Hospital Centre
Sherbrooke, Quebec
Canada

Contactez l'équipe d'étude

Tom Baker Cancer Centre
Tom Baker Cancer Centre
Calgary, Alberta
Canada

Contactez l'équipe d'étude

Backup Contact

Jeff Cao

Primary Contact

Marny Yar

BC Cancer - Vancouver Centre
BC Cancer - Vancouver Centre
Vancouver, British Columbia
Canada

Contactez l'équipe d'étude

Primary Contact

Ketki Merchant

Backup Contact

Alan Nichol

The Ottawa Hospital Regional Cancer Centre
The Ottawa Hospital Regional Cancer Centre
Ottawa, Ontario
Canada

Contactez l'équipe d'étude

Primary Contact

Krista Liimatainen

Backup Contact

Lynn Chang

Hotel-Dieu de Lévis (CISSS CA)
Hotel-Dieu de Lévis (CISSS CA)
Lévis, Quebec
Canada

Contactez l'équipe d'étude

Primary Contact

Pierre Bedard

Backup Contact

Anne Dagnault

CHU-de Québec-Université de Laval
CHU-de Québec-Université de Laval
Quebec City, Quebec
Canada

Contactez l'équipe d'étude

Primary Contact

Josee Allard

Backup Contact

Valerie Theberge

BC Cancer - Centre for the Southern Interior
BC Cancer - Centre for the Southern Interior
Kelowna, British Columbia
Canada

Contactez l'équipe d'étude

Backup Contact

Angela Lin

Primary Contact

Kiana Wong

Juravinski Cancer Centre
Juravinski Cancer Centre
Hamilton, Ontario
Canada

Contactez l'équipe d'étude

Primary Contact

Brenda DeMedeiros

Backup Contact

Tim Whelan

Sunnybrook Health Sciences Centre - Odette Cancer Centre
Sunnybrook Health Sciences Centre - Odette Cancer Centre
Toronto, Ontario
Canada

Contactez l'équipe d'étude

Primary Contact

Clarissa Chau

Backup Contact

Eileen Rakovitch

McGill University Health Centre-Cedars Cancer Centre
McGill University Health Centre-Cedars Cancer Centre
Montréal, Quebec
Canada

Contactez l'équipe d'étude

Primary Contact

Marianna Perna

Backup Contact

Tarek Hijal

Allan Blair Cancer Centre
Allan Blair Cancer Centre
Regina, Saskatchewan
Canada

Contactez l'équipe d'étude

Backup Contact

Derek Suderman

Primary Contact

Bernadette Procyk

BC Cancer - Centre for the North
BC Cancer - Centre for the North
Prince George, British Columbia
Canada

Contactez l'équipe d'étude

Backup Contact

Robert Olson, MD

Primary Contact

Robert Olson, MD

[email protected]
250-645-7325
Backup Contact

Dustin Mackay

[email protected]
250-645-7300
London Regional Cancer Program
London Regional Cancer Program
London, Ontario
Canada

Contactez l'équipe d'étude

Backup Contact

Francisco Perera

Primary Contact

Alisha Moynahan

Princess Margaret Cancer Centre - UHN
Princess Margaret Cancer Centre - UHN
Toronto, Ontario
Canada

Contactez l'équipe d'étude

Backup Contact

Kathy Han

Primary Contact

Vicky Gillman

CHUM - Centre Hospitalier de L'Universite de Montreal
CHUM - Centre Hospitalier de L'Universite de Montreal
Montréal, Quebec
Canada

Contactez l'équipe d'étude

Backup Contact

Pierre Rousseau

Primary Contact

Mom Phat

Saskatoon Cancer Centre
Saskatoon Cancer Centre
Saskatoon, Saskatchewan
Canada

Contactez l'équipe d'étude

Primary Contact

Shavaun Liss

Backup Contact

Philip Wright

Étude parrainée par
Ontario Clinical Oncology Group (OCOG)
Participants recherchés
Plus d'informations
ID de l'étude: NCT04228991