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

Breast Cancer Clinical Trial

Official title:

A Prospective Clinical Utility Study of the Impact of the 21 Gene Recurrence Score® Assay (Oncotype DX®) in Estrogen Receptor Positive (ER+) HER-2 Negative (HER 2-) 1-3 Node Positive (pN1) Breast Cancer in Multiple BC Cancer Agency Centres

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02627703
• Other study ID #: 01-168
• Status: Recruiting
• Phase: N/A
• First received: November 23, 2015
• Last updated: July 18, 2016
• Start date: May 2010

Study information

• Verified date: July 2016
• Source: British Columbia Cancer Agency
• Contact: Stephen Chia, MD
• Phone: 604-877-6000
• Email: schia[@]bccancer.bc.ca
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational

Clinical Trial 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.

Description:

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 study also has a pharmacoeconomic component. All eligible patients in which either physician and/or patient determine that results from the 21 gene recurrence score could provide additional information useful in the decision making process regarding adjuvant chemotherapy or not will be asked by the participating physicians to participate in the study. If interested, the patient will consent to the study. The physician will complete a baseline questionnaire to document recommended adjuvant systemic therapies (pre-Oncotype DX®). The Oncotype DX® assay will be ordered after receipt of the Physician and Patient Registration and assignment of patient study number. The physician will discuss the results of the Oncotype DX® assay with the patient once the result is available and upon receipt of the pre-test questionnaire. The physician will complete a follow-up questionnaire (to document recommended adjuvant systemic therapies post Oncotype DX®) after the result of the Oncotype DX® assay is known.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 79 Years

Eligibility

Inclusion Criteria:

1. Operable breast cancer with the primary tumour (pT1-3)

2. 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.

3. Her2Neu negative by IHC (0 or 1+) or FISH by current ASCO/CAP guidelines

4. Patient's tumor must undergo central review at GHI and there must be adequate material for the Oncotype DX® assay.

5. Patient's tumor must contain estrogen receptors (ER+).

6. Patient must be between the ages (inclusive) of 18-79.

7. Patient must be able to give informed consent

8. 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

Exclusion Criteria:

1. Patients have ER negative tumors (ER-) by local or central BCCA assessment

2. Patients have HER2 positive tumors by local or central BCCA assessment

3. Patients have four or more lymph node positive disease.

4. Lymph node involvement by isolated tumor cells or cells by IHC only (less than 200 cells and/or =0.2 mm)

5. Patients have known metastatic breast cancer.

6. Patients are unable to give consent or understand written language.

7. Patients with poor performance status (ECOG 2-4) in whom consideration of adjuvant chemotherapy or adjuvant hormonal therapy would be contraindicated.

8. Pregnant women in whom consideration of adjuvant chemotherapy or adjuvant hormonal therapy would be contraindicated.

9. Patients with tumors that on GHI central pathological review appears inadequate for the Oncotype DX® assay.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• Oncotype DX
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.

Locations

Country	Name	City	State
Canada	BC Cancer Agency - Vancouver Centre	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
British Columbia Cancer Agency	Genomic Health®, Inc.

Country where clinical trial is conducted

Canada, 

References & 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Assessing Costs differences to the Publicly funded Health Care System	Costs to a publicly funded health care system	Data will be analyzed within 8 weeks of enrollment completion and presented within 9 months of study completion	No