Trial Title:
Radiation OmisSion in PAtients With CLinically Node Negative Breast Cancer Undergoing Lumpectomy
NCT ID:
NCT05866458
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
Clinically node negative breast cancer
Ipsilateral breast tumour recurrence
Neoadjuvant chemotherapy
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
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.
Criteria for eligibility:
Study pop:
Written informed consent will be obtained from all eligible patients who agree to
participate. Until the patient has been completely informed of the study, has freely
consented to take part in the study and has signed and dated an informed consent form
that has received documented approval by an authorized Research Ethics Board (REB), no
study related assessments, including those required for screening can be performed.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
1. Female patient with a new histological diagnosis of clinical T1-3 N0 breast cancer
(any tumour sub-type).
2. Negative lymph node involvement at initial presentation, documented by imaging (US
or MRI), fine needle aspiration (FNA) or core needle biopsy.
3. Treated with a minimum of 8 weeks NAC, with patients with Her2+ disease receiving
targeted anti-Her2+ therapy.
4. Marker clip placed in the tumour bed prior to or during neoadjuvant chemotherapy
when the tumour can still be identified.
5. Treated by BCS with complete excision of the tumour bed and axillary staging surgery
(either sentinel lymph node biopsy or axillary lymph node dissection).
6. Final pathology demonstrating a pCR [defined as absence of residual invasive and
in-situ breast cancer within the breast or lymph nodes (ypT0N0)].
Exclusion Criteria:
1. Age less than 50 years.
2. Inflammatory breast cancer or breast cancer invading the skin or chest wall (T4
disease).
3. Multicentric disease (i.e., breast cancer involving more than one quadrant in the
same breast).
4. Prior history of ipsilateral or contralateral in-situ or invasive breast cancer.
Patients with a history of lobular carcinoma in-situ (LCIS) are ineligible.
5. Synchronous contralateral in-situ or invasive breast cancer.
6. BRCA (breast cancer gene) 1 or 2 genetic mutation carrier, or other genetic mutation
present associated with increased risk of breast cancer.
7. Other previous non-breast malignancies except adequately treated non-melanoma skin
cancers, in situ cancers or other cancers curatively treated with no evidence of
disease for ≥ 5 years.
8. Inability to complete entire course of neoadjuvant therapy (minimum of 8 weeks of
treatment).
9. Patients with HR+ (hormone receptor) disease who are not planned to have endocrine
therapy initiated.
10. Patients with Her2+ disease who have not received or are not planned to receive Her2
targeted therapy.
11. ECOG (Eastern Cooperative Oncology Group) performance status > 3.
12. Inability to provide informed consent.
Gender:
Female
Minimum age:
50 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Juravinski Cancer Centre
Address:
City:
Hamilton
Zip:
L8V 5C2
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Meaghan Preston
Phone:
905-521-2100
Phone ext:
47106
Email:
prestm1@mcmaster.ca
Investigator:
Last name:
Elena Parvez, Dr.
Email:
Principal Investigator
Facility:
Name:
Thunder Bay Regional Health Sciences Centre
Address:
City:
Thunder Bay
Zip:
P7B 6V4
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Martina Agostino
Phone:
807-684-7566
Email:
martina.agostino@tbh.net
Contact backup:
Last name:
Di-anne Salo
Phone:
807-684-7566
Email:
di-anne.salo@tbh.net
Investigator:
Last name:
Margaret Anthes, Dr
Email:
Principal Investigator
Facility:
Name:
Sunnybrook Health Sciences -Odette Cancer Centre
Address:
City:
Toronto
Zip:
M4N 3M5
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Carolyn Lim
Phone:
416-480-5000
Phone ext:
67219
Email:
carolyn.lim@sunnybrook.ca
Investigator:
Last name:
Irene Karam, Dr
Email:
Principal Investigator
Facility:
Name:
Jewish General Hospital
Address:
City:
Montréal
Zip:
H3T 1E2
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Olga Prescornic
Phone:
514-340-8222
Phone ext:
23471
Email:
olga.prescornic.ccomtl@ssss.gouv.qc.ca
Investigator:
Last name:
Thierry Muanza, Dr
Email:
Principal Investigator
Investigator:
Last name:
Mark Baski, Dr
Email:
Sub-Investigator
Facility:
Name:
CHU de Quebec - Universite Laval
Address:
City:
Quebec City
Zip:
G1R 2J6
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Josee Allard
Phone:
418-691-5264
Email:
josee.allard@chudequebec.ca
Investigator:
Last name:
Valerie Theberge, Dr
Email:
Principal Investigator
Facility:
Name:
Centre Hospitalier Trois Rivieres Ste-Marie
Address:
City:
Trois-Rivières
Zip:
G8Z 3R9
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Marie-Eve Caron
Phone:
819-697-3333
Phone ext:
63239
Email:
marie-eve_caron_chrtr@ssss.gouv.qc.ca
Contact backup:
Last name:
Julie Samson
Phone:
819-697-3333
Phone ext:
64832
Email:
julie_samson_ciusssmcq@ssss.gouv.qc.ca
Investigator:
Last name:
Rafika Dahmane, Dr
Email:
Principal Investigator
Start date:
March 12, 2024
Completion date:
October 2031
Lead sponsor:
Agency:
Ontario Clinical Oncology Group (OCOG)
Agency class:
Other
Source:
Ontario Clinical Oncology Group (OCOG)
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05866458
