RecruitingNCT05866458

Radiation OmisSion in PAtients With CLinically Node Negative Breast Cancer Undergoing Lumpectomy

Radiation OmisSion in PAtients With CLinically Node Negative Breast Cancer Undergoing Lumpectomy and With a PathologIc Complete REsponse After Neoadjuvant Chemotherapy

Sponsor

Ontario Clinical Oncology Group (OCOG)

Enrollment

352 participants

Start Date

Mar 12, 2024

Study Type

OBSERVATIONAL

Conditions

Breast Cancer

Summary

To de-escalate radiation therapy in women with breast cancer.

Eligibility

Sex: FEMALEMin Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study (ROSACAL) investigates whether radiation therapy can be safely skipped after lumpectomy (breast-conserving surgery) in women with breast cancer who had a complete pathological response to chemotherapy given before surgery — meaning no cancer was detectable in the removed tissue or lymph nodes. **You may be eligible if...** - You are 50 years or older - You have node-negative breast cancer (no spread to lymph nodes at diagnosis) - You completed at least 8 weeks of chemotherapy before surgery, achieving a complete response (no remaining cancer in the breast or lymph nodes after surgery) - You had breast-conserving surgery with axillary staging - A clip was placed in your tumor bed before or during chemotherapy **You may NOT be eligible if...** - You are under 50 years of age - You have inflammatory breast cancer or cancer invading skin or chest wall - You have a BRCA1 or BRCA2 gene mutation - You have cancer in multiple areas of the same breast - You have had a previous breast cancer in the same or other breast Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(27)

Tweed Valley Hospital

Cudgen, Cudgen, Australia

Liverpool Hospital

Liverpool, New South Wales, Australia

Mater Hospital Sydney

North Sydney, New South Wales, Australia

Westmead Hospital

Westmead, New South Wales, Australia

Royal Brisbane and Women's Hospital

Herston, Queensland, Australia

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Monash Medical Centre -Moorabbin

Bentleigh East, Victoria, Australia

Victorian Breast & Oncology Care (VBOC)

East Melbourne, Victoria, Australia

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

St. Vincent's Hospital Melbourne

Melbourne, Victoria, Australia

Sir Charles Gairdner Hospital

Nedlands, Western Australia, Australia

Maroondah Hospital

Box Hill, Australia

Royal Perth Hospital

Perth, Australia

Prince of Wales Hospital

Randwick, Australia

Latrobe Regional Health

Traralgon, Australia

BC Cancer - Centre for the North

Prince George, British Columbia, Canada

Royal Victoria Regional Health Centre

Barrie, Ontario, Canada

Juravinski Cancer Centre

Hamilton, Ontario, Canada

Cancer Centre of Southeastern Ontario at Kingston

Kingston, Ontario, Canada

Thunder Bay Regional Health Sciences Centre

Thunder Bay, Ontario, Canada

Sunnybrook Health Sciences -Odette Cancer Centre

Toronto, Ontario, Canada

CHUM - Centre Hospitalier de L'Université de Montréal

Montreal, Quebec, Canada

Jewish General Hospital

Montreal, Quebec, Canada

CHU de Quebec - Universite Laval

Québec, Quebec, Canada

Centre hospitalier de Lanaudière

Saint-Charles-Borromée, Quebec, Canada

Centre Hospitalier Trois Rivieres Ste-Marie

Trois-Rivières, Quebec, Canada

McGill University Health Centre (MUHC)

Montreal, Q, Canada

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT05866458

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