ELISA: Prospective Evaluation of Breast-Conserving Surgery Alone in Low-Risk Ductal Carcinoma in Situ (DCIS)

Sponsor

Ontario Clinical Oncology Group (OCOG) (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04797299

Collaborator

(none)

526

Enrollment

Locations

159

Anticipated Duration (Months)

75.1

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To evaluate whether the combination of clinicopathological factors and the use of the Oncotype DX DCIS score can avoid radiation in women with low risk DCIS who have had breast conserving surgery (BCS)

Condition or Disease	Intervention/Treatment	Phase
DCIS

Detailed Description

A prospective cohort study, conducted in Canada, to prospectively evaluate whether the combination of clinicopathological criteria and the Oncotype DX DCIS score can identify a group of women at very low risk of local recurrence following breast conserving surgery who do not require breast radiation therapy. We plan to screen 809 consenting women who will have their tumour tissue specimen sent to Exact Sciences to assess their DCIS score. We anticipate that 526 women will have an Oncotype DX DCIS score <39 and a predicted 10-year risk of local recurrence <10%, these patients will be enrolled and followed as part of the study.

At each centre, all patients with DCIS referred to radiation oncology will be documented. When a physician identifies an eligible patient, the patient will be approached by the referring physician or delegate to voluntarily provide informed consent to participate in this study. Consenting patients will be registered through the Ontario Clinical Oncology Group's (OCOG) web-based registration system. A two-step registration/enrollment process will be implemented.

Data related to the patient demographics, surgery details, tumour characteristics and ECOG performance will be collected. The patient's tumour specimen will be sent for analysis to Exact Sciences. The DCIS score results will be sent to the referring physician. OCOG will also receive the DCIS score results. Patients will be followed every 6 months for the first 2 years and then yearly up to 10 years. Bilateral mammograms will be performed 6 months after BCS and then annually. The study data will be verified by source documentation.

Study Design

Study Type:

Observational

Anticipated Enrollment :

526 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Prospective Evaluation of Breast-Conserving Surgery Alone in Low-Risk Ductal Carcinoma in Situ Defined by a Molecular Expression Assay Combined With Clinico-Pathological Features

Anticipated Study Start Date :

May 1, 2022

Anticipated Primary Completion Date :

Mar 31, 2035

Anticipated Study Completion Date :

Jul 31, 2035

Arms and Interventions

Arm	Intervention/Treatment
Single Arm Cohort Evaluating the risk of Local Recurrence (LR) in a group of women postulated to be at low risk of LR following Breast Conserving Surgery alone defined by a combination of clinicopathological factors and Oncotype DX DCIS score.

Outcome Measures

Primary Outcome Measures

Ipsilateral local recurrence (LR) [5 Year]
Defined as recurrent invasive or in situ cancer in the ipsilateral breast

Secondary Outcome Measures

Ipsilateral invasive local recurrence [5 Year]
defined as time from study registration to time of recurrent invasive cancer in the ipsilateral breast
Breast cancer recurrence-free interval (RFI) [5 Year]
defined as time from study registration to time of documented recurrent disease (ipsilateral breast (DCIS or invasive), regional, distant or death from breast cancer
Distant disease-free survival (DDFS) [5 Year]
defined as time from study registration to distant recurrence
Disease-free survival (DFS) [5 Year]
defined as time from registration to time of LR (DCIS or invasive), regional and distant recurrence, contralateral breast cancer, new primary (non-breast) and death from any cause
Overall survival (OS) [5 Year]
defined as time from registration to death of any cause

Eligibility Criteria

Criteria

Ages Eligible for Study:

46 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Female patient > 45 years of age with DCIS without microinvasion.
Tumour size ≤ 2.5cm.
Treated by BCS with clear resection margins ≥ 2 mm or no residual disease on re-excision.
Oncotype DX DCIS score < 39 and predicted 10-year risk of LR <10%.

Exclusion Criteria:

Multifocal DCIS.
History of any invasive breast cancer or non-invasive breast cancer in the ipsilateral breast.
Synchronous or previous invasive or non-invasive breast cancer.
Prior history of invasive cancer within the last 5 years, excluding non-melanoma skin cancers.
ECOG performance status ≥3.
Life expectancy <10 years.
Geographic inaccessibility for follow-up.
Inability to provide informed consent.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Juravinski Cancer Centre	Hamilton	Ontario	Canada	L8V 5C2
2	Cancer Centre of Southeastern Ontario, Kingston General Hospital	Kingston	Ontario	Canada	K7L 5P9
3	London Regional Cancer Program	London	Ontario	Canada	N6A 4L6
4	Walker Family Cancer Centre, Niagara Health System,St. Catharines	St. Catharines	Ontario	Canada	L2S 0A9
5	Regional Cancer Care, Thunder Bay Regional Health Sciences Centre	Thunder Bay	Ontario	Canada	P7B 6V4
6	Sunnybrook Health Science Centre -Odette Cancer Centre	Toronto	Ontario	Canada	M4N 3M5
7	University Health Network - Princess Margaret Cancer Centre	Toronto	Ontario	Canada	M5G 2M9

Sponsors and Collaborators

Ontario Clinical Oncology Group (OCOG)

Investigators

Principal Investigator: Tim Whelan, M.D., Juravinski Cancer Centre
Principal Investigator: Eileen Rakovitch, M.D, Sunnybrook Research Institute, Sunnybrook Health Science