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

DCIS Clinical Trial

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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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04797299
• Other study ID #: OCOG-2021-ELISA
• Status: Recruiting
• Start date: November 23, 2022
• Est. completion date: May 31, 2035

Study information

• Verified date: May 2024
• Source: Ontario Clinical Oncology Group (OCOG)
• Contact: Brittany Speller
• Phone: 905-527-2299
• Email: spelleb[@]mcmaster.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 526
• Est. completion date: May 31, 2035
• Est. primary completion date: March 31, 2035
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 46 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma in Situ
• Carcinoma, Ductal
• Carcinoma, Intraductal, Noninfiltrating
• DCIS

Locations

Country	Name	City	State
Canada	Tom Baker Cancer Centre	Calgary	Alberta
Canada	Cross Cancer Institute	Edmonton	Alberta
Canada	Hôpital Charles Le Moyne (CISSS de la Montérégie-Centre)	Greenfield Park	Quebec
Canada	QE II HSC - Nova Scotia Cancer Centre	Halifax	Nova Scotia
Canada	Juravinski Cancer Centre	Hamilton	Ontario
Canada	London Regional Cancer Program	London	Ontario
Canada	CHUM - Centre Hospitalier de L'Université de Montréal	Montreal	Quebec
Canada	Jewish General Hospital	Montréal	Quebec
Canada	McGill University Health Centre	Montréal	Quebec
Canada	BC Cancer - Centre for the North (Prince George)	Prince George	British Columbia
Canada	Centre intégré de cancérologie du CHU de Québec - Université Laval	Québec City	Quebec
Canada	Cape Breton Cancer Centre	Sydney	Nova Scotia
Canada	Regional Cancer Care, Thunder Bay Regional Health Sciences Centre	Thunder Bay	Ontario
Canada	Sunnybrook Health Science Centre -Odette Cancer Centre	Toronto	Ontario
Canada	University Health Network - Princess Margaret Cancer Centre	Toronto	Ontario
Canada	Centre Intégré Universitaire de Santé et de Services Sociaux de la Mauricie- Centre-du-Québec (CIUSSS MCQ) - Trois-Rivières	Trois-Rivières	Quebec
Canada	BC Cancer - Vancouver Centre	Vancouver	British Columbia
Canada	BC Cancer - Victoria	Victoria	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Ontario Clinical Oncology Group (OCOG)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ipsilateral local recurrence (LR)	Defined as recurrent invasive or in situ cancer in the ipsilateral breast	5 Year
Secondary	Ipsilateral invasive local recurrence	defined as time from study registration to time of recurrent invasive cancer in the ipsilateral breast	5 Year
Secondary	Breast cancer recurrence-free interval (RFI)	defined as time from study registration to time of documented recurrent disease (ipsilateral breast (DCIS or invasive), regional, distant or death from breast cancer	5 Year
Secondary	Distant disease-free survival (DDFS)	defined as time from study registration to distant recurrence	5 Year
Secondary	Disease-free survival (DFS)	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	5 Year
Secondary	Overall survival (OS)	defined as time from registration to death of any cause	5 Year

External Links

•   OCOG website accessed by clinical centres