Recruiting

Oncotype DX

Sponsor:

British Columbia Cancer Agency

Code:

NCT02627703

Conditions

Breast Cancer

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Oncotype DX

Study Details

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

Study ID

NCT02627703

Start date

May, 2010

Status verified date

Jul, 2016

Primary completion date

Dec, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

80 participants

Anticipated

Interventions and Outcome Measures

Interventions

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.

Primary outcome measure

  • Oncotype DX® assay affect on physician's treatment recommendations assessed by questionnaire [ Time Frame: 1 Month ]

Central Contacts and Locations

Central contacts

Locations

BC Cancer Agency - Vancouver Centre

Recruiting

Vancouver, British Columbia, Canada, V5Z4E6

Contacts

More Information

Sponsor

British Columbia Cancer Agency

Last update posted

Jul 20, 2016

Last verified

Jul, 2016

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by British Columbia Cancer Agency on 2016-07-20.