NCT02347449

Brief Summary

The main goal of this study is to characterize whether the results of the Oncotype DX® assay affect the physician's treatment recommendations for the adjuvant treatment of women with ER-positive (ER+), early breast cancer (EBC) with 1-3 positive lymph nodes who are potential candidates for chemotherapy, but for whom the benefits of chemotherapy may be uncertain.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 17, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 27, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2016

Completed
Last Updated

October 23, 2020

Status Verified

October 1, 2020

Enrollment Period

2 years

First QC Date

November 17, 2014

Last Update Submit

October 21, 2020

Conditions

Hormone Receptor Positive Malignant Neoplasm of Breast

Keywords

Early-stage Breast cancer, node positivePrognosisOncotype Dx

Outcome Measures

Primary Outcomes (1)

  • Change in physicians' treatment recommendations

    2-4 weeks

Secondary Outcomes (3)

  • Change in patient's treatment preference and level of confidence in treatment plan

    2-4 weeks

  • Change in physicians' level of confidence in the treatment recommendation

    2-4 weeks

  • Specific chemotherapy and/or hormone therapy regimen received by patient

    4-8 weeks

Study Arms (1)

Early stage breast cancer

EXPERIMENTAL

Women with node positive (1-3 nodes), ER positive breast cancer who are receiving (or will receive) endocrine therapy, and who are candidates for chemotherapy. Study subjects will have ONCOTYPE Dx assay performed on their breast tumors, and will complete study questionnaires.

Other: Questionnaires, Oncotype Dx Assay

Interventions

Questionnaires, Oncotype Dx AssayOTHER

1. Physician pre-assay questionnaire 2. Patient pre-assay questionnaire 3. Oncotype DX® Assay 4. Physician post- assay questionnaire 5. Patient post-assay questionnaire

Also known as: Oncotype Dx Assay, Questionnaires
Early stage breast cancer

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must have undergone surgical treatment for breast cancer with adequate evaluation of lymph node status with a sentinel lymph node procedure or full axillary dissection, with positive involvement of 1-3 axillary lymph nodes as confirmed by histologic examination.
  • ECOG performance status 0 or 1
  • Patient must be a candidate for treatment of their cancer with systemic chemotherapy in addition to hormonal therapy
  • Eligible Staging Criteria: T1-3 N1 M0
  • Breast tumor must undergo central pathology review at GHI and must be found adequate for the Oncotype DX assay.
  • Breast tumor must be estrogen-receptor positive and HER2 positive (IHC/FISH) as per institutional guidelines

You may not qualify if:

  • Patient has a prior history of breast cancer in the same breast
  • Patient as been newly diagnosed with more than one operable primary breast tumor
  • Patient has multi-centric tumors (note: patients with multi-focal tumors may be included)
  • Patient has known metastatic breast cancer
  • Patient has \<2mm invasive tumor as assessed by local pathologist
  • Patient has received any kind of neoadjuvant treatment
  • Presence of clinical factors rendering the patient a non-viable candidate for adjuvant chemotherapy
  • Presence of a current medical condition that would interfere with patient's ability to consent and participate in this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Andrea Eisen, MD

    Sunnybrook Health Sciences Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2014

First Posted

January 27, 2015

Study Start

October 1, 2014

Primary Completion

September 30, 2016

Study Completion

September 30, 2016

Last Updated

October 23, 2020

Record last verified: 2020-10

Locations

CA(1)