Clinical trial NCT04797299: Prospective Evaluation of Breast-Conserving Surgery Alone in Low-Risk Ductal Carcinoma in Situ (DCIS)
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: DCIS
Keywords: Ductal Carcinoma in Situ
Breast Conserving Surgery
Oncotype DX DS
Lead sponsor: Ontario Clinical Oncology Group (OCOG)
Sponsor class: OTHER
First posted: 2021-03-15
Enrollment: 526
Sex: FEMALE
Minimum age (years): 46
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Prospective cohort study conducted in Canada in women with a low risk DCIS following breast conserving surgery who are candidates for radiation.

Eligibility status should be confirmed by the referring physician or delegate prior to enrollment. It is important that no exceptions are made to the eligibility criteria. Questions related to eligibility requirements and/or specific criteria should be addressed with OCOG prior to enrollment

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)

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 with a predicted 10-year risk of local recurrence ≤10%, these women 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 yearly up to 10 years. Bilateral mammograms and breast exams will be performed annually. The study data will be verified by source documentation.

Eligibility criteria: Inclusion Criteria:

1. Female patient \> 45 years of age with DCIS without microinvasion.
2. Tumour size ≤ 2.5cm.
3. Treated by BCS with clear resection margins ≥ 2 mm or no residual disease on re-excision.\*

   \* Patients with anterior margins and posterior margins ≥1 mm are eligible. Or if the dissection was confirmed to be taken to skin and down to fascia with no DCIS present at inked margins.
4. Oncotype DX DCIS score with a predicted 10-year risk of LR ≤10%.

Exclusion Criteria:

1. Multifocal DCIS.
2. History of any invasive breast cancer or non-invasive breast cancer in the ipsilateral breast.
3. Synchronous or previous invasive or non-invasive breast cancer.
4. Prior history of invasive cancer within the last 5 years, excluding non-melanoma skin cancers.
5. ECOG performance status ≥3.
6. Life expectancy \<10 years.
7. Geographic inaccessibility for follow-up.

Primary outcomes:
measure: Ipsilateral local recurrence (LR)
timeFrame: 5 Year
Secondary outcomes:
measure: Ipsilateral invasive local recurrence
timeFrame: 5 Year
measure: Breast cancer recurrence-free interval (RFI)
timeFrame: 5 Year
measure: Distant disease-free survival (DDFS)
timeFrame: 5 Year
measure: Disease-free survival (DFS)
timeFrame: 5 Year
measure: Overall survival (OS)
timeFrame: 5 Year
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Arthur J.E. Child Comprehensive Cancer Centre
state: Alberta
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
city: Abbotsford
country: Canada
facility: BC Cancer - Abbotsford Centre
state: British Columbia
city: Prince George
country: Canada
facility: BC Cancer - Centre for the North (Prince George)
state: British Columbia
city: Surrey
country: Canada
facility: BC Cancer - Fraser Valley Centre
state: British Columbia
city: Vancouver
country: Canada
facility: BC Cancer - Vancouver Centre
state: British Columbia
city: Victoria
country: Canada
facility: BC Cancer - Victoria
state: British Columbia
city: Halifax
country: Canada
facility: QE II HSC - Nova Scotia Cancer Centre
state: Nova Scotia
city: Sydney
country: Canada
facility: Cape Breton Cancer Centre
state: Nova Scotia
city: Hamilton
country: Canada
facility: Juravinski Cancer Centre
state: Ontario
city: London
country: Canada
facility: London Regional Cancer Program
state: Ontario
city: Thunder Bay
country: Canada
facility: Regional Cancer Care, Thunder Bay Regional Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Science Centre -Odette Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: University Health Network - Princess Margaret Cancer Centre
state: Ontario
city: Windsor
country: Canada
facility: Windsor Regional Cancer Centre
state: Ontario
city: Greenfield Park
country: Canada
facility: Hôpital Charles Le Moyne (CISSS de la Montérégie-Centre)
state: Quebec
city: Montreal
country: Canada
facility: CHUM - Centre Hospitalier de L'Université de Montréal
state: Quebec
city: Montréal
country: Canada
facility: Jewish General Hospital
state: Quebec
city: Montréal
country: Canada
facility: McGill University Health Centre
state: Quebec
city: Québec City
country: Canada
facility: Centre intégré de cancérologie du CHU de Québec - Université Laval
state: Quebec
city: Trois-Rivières
country: Canada
facility: Centre Intégré Universitaire de Santé et de Services Sociaux de la Mauricie- Centre-du-Québec (CIUSSS MCQ) - Trois-Rivières
state: Quebec
Study officials:
affiliation: Sunnybrook Research Institute, Sunnybrook Health Science
name: Eileen Rakovitch, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Juravinski Cancer Centre
name: Tim Whelan, M.D
role: PRINCIPAL_INVESTIGATOR
References: