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Spots Global Cancer Trial Database for Radiation OmisSion in PAtients With CLinically Node Negative Breast Cancer Undergoing Lumpectomy

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Trial Identification

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

Conditions

Breast Cancer

Interventions

Study Description

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.

Eligibility

Minimum Age: 50 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

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

Contact Details

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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