(Oncotype DX®) in Estrogen Receptor Positive (ER+) HER-2 Negative (HER 2-) 1-3 Node Positive (pN1) Breast Cancer

NCT02627703 | Unknown

• 1 other identifier: 01-168
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a multi-center BCCA study that evaluates the impact of the Oncotype DX® assay on the decision making of the treating physician and the patient. The Oncotype DX® assay is a commercially available diagnostic test that aids in a physician's treatment recommendation to a breast cancer patient. The study also has a pharmacoeconomic component.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Oncotype DX® assay affect on physician's treatment recommendations assessed by questionnaire

  The Oncotype DX® assay affect on physician's treatment recommendations pre and post Oncotype DX® Recurrence Score® result.

  1 Month

Secondary Outcomes (1)

• Assessing Costs differences to the Publicly funded Health Care System

  Data will be analyzed within 8 weeks of enrollment completion and presented within 9 months of study completion

Interventions

Oncotype DX OTHER

The Oncotype DX® assay is a multi-gene reverse-transcriptase-polymerase-chain-reaction (RT-PCR) test that analyzes the expression of 21 genes, and quantifies the 10 year distant breast cancer recurrence risk in patients with stage I and II, lymph node negative, estrogen receptor positive disease who plan to be treated with tamoxifen for 5 years.

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

* 18-79 years old * Operative Primary Breast Cancer * Node + (N1-3: micrometastasis) * ER + and HER 2- * Candidate for adjuvant chemotherapy in addition to hormonal therapy

You may qualify if:

• Operable breast cancer with the primary tumour (pT1-3)
• Pathological involvement (microscopic) of 1-3 lymph nodes. No minimum number of total lymph nodes need be resected. Extra-nodal extension of nodal deposit is allowed.
• Her2Neu negative by IHC (0 or 1+) or FISH by current ASCO/CAP guidelines
• Patient's tumor must undergo central review at GHI and there must be adequate material for the Oncotype DX® assay.
• Patient's tumor must contain estrogen receptors (ER+).
• Patient must be between the ages (inclusive) of 18-79.
• Patient must be able to give informed consent
• Patient has adequate performance status (PS ECOG 0,1 or Karnofsky ≥70) and be a medically fit candidate for treatment of their cancer with systemic chemotherapy in addition to hormonal therapy with no contra-indications to either systemic therapy maneuvers

You may not qualify if:

• Patients have ER negative tumors (ER-) by local or central BCCA assessment
• Patients have HER2 positive tumors by local or central BCCA assessment
• Patients have four or more lymph node positive disease.
• Lymph node involvement by isolated tumor cells or cells by IHC only (less than 200 cells and/or ≤0.2 mm)
• Patients have known metastatic breast cancer.
• Patients are unable to give consent or understand written language.
• Patients with poor performance status (ECOG 2-4) in whom consideration of adjuvant chemotherapy or adjuvant hormonal therapy would be contraindicated.
• Pregnant women in whom consideration of adjuvant chemotherapy or adjuvant hormonal therapy would be contraindicated.
• Patients with tumors that on GHI central pathological review appears inadequate for the Oncotype DX® assay.

Sponsors & Collaborators

• British Columbia Cancer Agency: lead
• Genomic Health®, Inc.: collaborator

Study Sites (1)

BC Cancer Agency - Vancouver Centre

Vancouver, British Columbia, V5Z4E6, Canada

RECRUITING

Related Publications (1)

• Davidson JA, Cromwell I, Ellard SL, Lohrisch C, Gelmon KA, Shenkier T, Villa D, Lim H, Sun S, Taylor S, Taylor M, Czerkawski B, Hayes M, Ionescu DN, Yoshizawa C, Chao C, Peacock S, Chia SK. A prospective clinical utility and pharmacoeconomic study of the impact of the 21-gene Recurrence Score(R) assay in oestrogen receptor positive node negative breast cancer. Eur J Cancer. 2013 Jul;49(11):2469-75. doi: 10.1016/j.ejca.2013.03.009. Epub 2013 Apr 20.

  PMID: 23611660 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Stephen Chia, MD

CONTACT

604-877-6000; schia@bccancer.bc.ca

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2015
• First Posted: December 11, 2015
• Study Start: May 1, 2010
• Primary Completion: December 1, 2017
• Last Updated: July 20, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)