Breast Cancer Clinical Trial
— EROfficial title:
Informative Tools to Optimize Neoadjuvant Therapy in ER Positive, HER2 Negative Breast Cancers
This study evaluates the addition of Ki-67, Oncotype DX and MRI in the treatment of early stage breast cancer with neoadjuvant treatment. All enrolled patients will have Ki-67 and Oncotype AND/OR an MRI before and after surgery.
Status | Not yet recruiting |
Enrollment | 50 |
Est. completion date | December 31, 2023 |
Est. primary completion date | December 31, 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 89 Years |
Eligibility |
Inclusion Criteria: 1. Patient must be between the ages (inclusive) of 18-89. 2. Patient has adequate performance status (PS ECOG 0,1 or Karnofsky performance status =70) and is a medically fit candidate for treatment of their cancer with systemic chemotherapy and/or hormonal therapy with no contra-indications to both systemic therapy options. 3. Patient is medically fit enough to be a surgical candidate. 4. Patient must be able to give informed consent directly or through the assistance of an interpreter. 5. Pathological confirmation of breast cancer by core biopsy. 6. Ductal or lobular breast cancer. 7. Breast cancer with a primary tumour (clinically selected T2-T4) OR clinically node positive. 8. Breast cancer is clinically palpable either in the breast, axilla or other nodal site. 9. ER positive by IHC (Allred >=4). 10. Her2Neu negative by IHC (0 or 1+) or FISH by current ASCO/CAP guidelines. Exclusion Criteria: 1. Patient is a male with breast cancer. 2. Patients have ER negative tumors (ER-) by local or central BCCA assessment. 3. Patients have HER2 positive tumors by local or central BCCA assessment. 4. Patients have known metastatic breast cancer or develop metastatic disease prior to surgery. 5. Patients are unable to give consent or understand written language. 6. Patients with poor performance status (ECOG 2-4) in whom consideration of neoadjuvant chemotherapy OR hormonal therapy would be contraindicated. 7. Patients who are not fit enough to be a surgical candidate. 8. Pregnant women in whom consideration of neoadjuvant chemotherapy or neoadjuvant hormonal therapy would be contraindicated. 9. Patients who receive less than 2 weeks of neoadjuvant systemic therapy. 10. Patients who have not undergone surgical resection 12 months after enrollment. For intervention 1 only: 1. Patients with tumors that on GHI central pathological review appears inadequate for the Oncotype DX® assay. 2. Patients with tumors that on BCCA pathological review appears inadequate for Ki-67 immunohistochemistry. For intervention 2 only: 1. Patients with a pacemaker or contra-indication to MRI. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
British Columbia Cancer Agency | Genomic Health®, Inc. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Feasibility of neoajduvant Ki-67 and Oncotype DX, defined as >=75% enrollment rate for all screened patients | • Technical feasibility of obtaining Ki-67 and Oncotype DX assay from a core biopsy sample in >= 75% of samples tested, prior to the initiation of systemic treatment. | 1 month | |
Primary | Turnaround time of Ki-67 and Oncotype DX, defined as time from patient consent to date results are obtained | Turnaround time will be defined as: Time from patient consent to reporting of the Ki-67 and Oncotype DX |
1 month | |
Primary | Feasibility of MRI prior to neoadjuvant systemic treatment, defined as >=75% of patients who receive an MRI before the start of neoadjuvant treatment | • Practical feasibility of obtaining serial MRIs with the existing means, resources and booking circumstances in >=75% of cases prior to the initiation of systemic therapy and surgical resection | 6 months | |
Primary | Turnaround time of MRI prior to neoadjuvant systemic treatment, defined as time from patient consent to date of 1st MRI | Turnaround time will be defined as: • Time from patient consent to pre-treatment (baseline) MRI |
6 months | |
Secondary | Correlation of Ki-67 and Oncotype DX to each other and to the outcome of neoadjuvant systemic treatment. | To characterize how the results of the Ki-67 Oncotype DX assay relate to the outcome of neoadjuvant systemic treatment and whether the results correlate to each other (Ki-67 and Oncotype DX). | 6 months | |
Secondary | Predictive association of Ki-67 and Oncotype to invasive locoregional or systemic relapse | • Time from study enrollment to the development of invasive locoregional or systemic breast cancer. | 5 years | |
Secondary | Predictive association of Ki-67 and Oncotype to overall survival | • Time from enrollment to death from any cause. | 5 years | |
Secondary | Impact of serial MRI on changes to surgical planning | Changes from original to final surgical plan. | 6 months | |
Secondary | Correlation of serial MRI to clinical and pathological response | Characterize how the results of serial MRIs affect surgical planning and how the radiological response relates to clinical response and pathological response. | 6 months | |
Secondary | Patient reported outcomes assessed by questionnaire | Patient reported outcomes assessed with a questionnaire exploring decisional conflict. 9 questions are asked of patients regarding the MRI results and its impact on decision making. The scale is a 5 point scale, ranging from strongly disagree (1) to strongly agree (5). Results will be reported qualitatively. |
6 months |
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