The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Brief Title: Radiation OmisSion in PAtients With CLinically Node Negative Breast Cancer Undergoing Lumpectomy
Official Title: Radiation OmisSion in PAtients With CLinically Node Negative Breast Cancer Undergoing Lumpectomy and With a PathologIc Complete REsponse After Neoadjuvant Chemotherapy
Study ID: NCT05866458
Brief Summary: To de-escalate radiation therapy in women with breast cancer.
Detailed Description: The study is a prospective, multi-center, single arm cohort study of omission of adjuvant whole breast radiation therapy (WBRT) following breast conserving surgery (BCS) in patients with a pathological complete response (pCR) following neoadjuvant chemotherapy (NAC). Eligible and consenting female patients with newly diagnosed T1-3 node negative breast cancer with no clinical evidence of distant metastatic disease, who have been treated with NAC, BCS and axillary staging surgery with final pathology demonstrating a pCR (ypT0N0) will be enrolled to the study and followed. The first analysis is planned when follow-up is a median of 5 years. Study participants will not receive adjuvant WBRT, the current standard of care. The primary outcome is ipsilateral breast tumour recurrence (IBTR) at median 5-year follow-up. Study participants will be followed and assessed for local recurrence, regional recurrence, distant recurrence, DFS and OS. In addition, any additional breast cancer treatments received by the participant for the first recurrence event including repeat BCS, mastectomy, additional systemic therapy and radiation therapy (RT) will be documented. The planned sample size is 352 study participants.
Minimum Age: 50 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Juravinski Cancer Centre, Hamilton, Ontario, Canada
Sunnybrook Health Sciences -Odette Cancer Centre, Toronto, Ontario, Canada
Jewish General Hospital, Montréal, Quebec, Canada
CHU de Quebec - Universite Laval, Quebec City, Quebec, Canada
Centre Hospitalier Trois Rivieres Ste-Marie, Trois-Rivières, Quebec, Canada
Name: Elena Parvez, MD
Affiliation: Juravinski Cancer Centre
Role: PRINCIPAL_INVESTIGATOR
Name: Thierry Muanza, MD
Affiliation: Jewish General Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Mark Basik, MD
Affiliation: Jewish General Hospital
Role: PRINCIPAL_INVESTIGATOR