Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Carcinoma

Carcinoma in Situ

Carcinoma, Ductal

Carcinoma, Intraductal, Noninfiltrating

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Breast Neoplasms

Breast Carcinoma In Situ

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.

Brittany Speller

Sharon Nason

Payal Thakkar

Jeffrey Q Cao, MD

Andrea Rosario

Kurian Joseph, MD

Sarah Zuccaro

Robert Olson, MD

Fermin Hoq

Iwa Kong, MD

Lily Hallett Rio

Negin Shahid, MD

Jessica Boddy

Robert Rutledge, MD

Alexandra Szeto

Kwamena Beecham, MD

Brenda DeMedeiros

Tim Whelan, MD

Alisha Moynahan

Francisco Perera, MD

Lori Moon

Margaret Anthes, MD

Clarissa Chau

Eileen Rakovitch, MD

Lea Dungao

Ezra Hahn, MD

Caroline Hivon

Nancy El-Bared, MD

Silvine Benth

Jean-Marc Bourque, MD

Marianna Perna

Christine Lambert, MD

Josée Allard

Valérie Théberge, MD

Marie-Eve Caron

Francois Vincent, MD

Eileen Rakovitch, M.D.

Tim Whelan, M.D

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)

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.

Specimens will be used to determine Oncotype DX DCIS Score and subsequent testing for future correlative studies

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

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

Defined as recurrent invasive or in situ cancer in the ipsilateral breast

defined as time from study registration to time of recurrent invasive cancer in the ipsilateral breast

defined as time from study registration to time of documented recurrent disease (ipsilateral breast (DCIS or invasive), regional, distant or death from breast cancer

defined as time from study registration to distant recurrence

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

defined as time from registration to death of any cause

Ontario Clinical Oncology Group (OCOG)

Spots Global Cancer Trial Database for oncotype dx ds