- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03790813
Informative Tools to Optimize Neoadjuvant Therapy in ER Positive, HER2 Negative Breast Cancers (ER)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Based on what is known about the treatment of breast cancer, there are occasional advantages to giving treatment before surgery. Some of these advantages can include shrinking a large breast cancer to facilitate surgery, shrinking a breast cancer to allow breast conservation (avoid a mastectomy), and evaluating how effective a treatment is in real-time, based on its effect on the breast cancer.
When recommending treatment with hormone therapy and/or chemotherapy, doctors take into consideration all the characteristics of a breast cancer. Over recent years, is has been recognized that additional tests can help predict the behavior of a cancer and predict the possible benefit of hormone therapy and/or chemotherapy. Because there is no way to identify exactly who benefits from chemotherapy, many patients receive chemotherapy when they might not need it.
This study involves the use of 2 separate tests. The first is called Ki-67 and is done using a piece of tumour that is taken during a needle biopsy. The second, called the Oncotype DX, is made by Genomic Health, Inc, located in Redwood, CA, USA. This test also uses a piece of tumour that was retrieved during a needle biopsy. The pieces will be tested in a specialized laboratory that can measure the levels of a specific set of genes in the tumour. The laboratory that performs this test (Redwood, CA, USA) has been certified by federal and state agencies in the United States to perform the test (called Oncotype DX). The results of the test are turned into a score (called Recurrence Score) that has been used for patients receiving treatment after surgery, but has not yet been used when treatment is given before surgery.
The standard practice for this type of cancer is for the patient and their doctor to decide whether they should receive chemotherapy in addition to hormone therapy or to take hormone therapy alone, prior to surgery. The Ki-67 is inconsistently used in British Columbia prior to surgery, but may be used routinely in other centers. Usually, the Oncotype DX test is not available to aid in this decision outside of a research study.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Nathalie LeVasseur, MD
- Phone Number: 604-877-6000x2734
- Email: nathalie.levasseur@bccancer.bc.ca
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patient must be between the ages (inclusive) of 18-89.
- 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.
- Patient is medically fit enough to be a surgical candidate.
- Patient must be able to give informed consent directly or through the assistance of an interpreter.
- Pathological confirmation of breast cancer by core biopsy.
- Ductal or lobular breast cancer.
- Breast cancer with a primary tumour (clinically selected T2-T4) OR clinically node positive.
- Breast cancer is clinically palpable either in the breast, axilla or other nodal site.
- ER positive by IHC (Allred >=4).
- Her2Neu negative by IHC (0 or 1+) or FISH by current ASCO/CAP guidelines.
Exclusion Criteria:
- Patient is a male with breast cancer.
- 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 known metastatic breast cancer or develop metastatic disease prior to surgery.
- Patients are unable to give consent or understand written language.
- Patients with poor performance status (ECOG 2-4) in whom consideration of neoadjuvant chemotherapy OR hormonal therapy would be contraindicated.
- Patients who are not fit enough to be a surgical candidate.
- Pregnant women in whom consideration of neoadjuvant chemotherapy or neoadjuvant hormonal therapy would be contraindicated.
- Patients who receive less than 2 weeks of neoadjuvant systemic therapy.
- Patients who have not undergone surgical resection 12 months after enrollment.
For intervention 1 only:
- Patients with tumors that on GHI central pathological review appears inadequate for the Oncotype DX® assay.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Eligible patients
|
Ki-67 and Oncotype DX® will be performed on the baseline core biopsy specimen prior to initiation of neoadjuvant systemic therapy.
MRI will be performed prior to initiation of neoadjuvant systemic therapy and at the end of treatment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility of neoajduvant Ki-67 and Oncotype DX, defined as >=75% enrollment rate for all screened patients
Time Frame: 1 month
|
• 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
|
Turnaround time of Ki-67 and Oncotype DX, defined as time from patient consent to date results are obtained
Time Frame: 1 month
|
|
1 month
|
Feasibility of MRI prior to neoadjuvant systemic treatment, defined as >=75% of patients who receive an MRI before the start of neoadjuvant treatment
Time Frame: 6 months
|
• 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
|
Turnaround time of MRI prior to neoadjuvant systemic treatment, defined as time from patient consent to date of 1st MRI
Time Frame: 6 months
|
Turnaround time will be defined as: • Time from patient consent to pre-treatment (baseline) MRI |
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlation of Ki-67 and Oncotype DX to each other and to the outcome of neoadjuvant systemic treatment.
Time Frame: 6 months
|
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
|
Predictive association of Ki-67 and Oncotype to invasive locoregional or systemic relapse
Time Frame: 5 years
|
• Time from study enrollment to the development of invasive locoregional or systemic breast cancer.
|
5 years
|
Predictive association of Ki-67 and Oncotype to overall survival
Time Frame: 5 years
|
• Time from enrollment to death from any cause.
|
5 years
|
Impact of serial MRI on changes to surgical planning
Time Frame: 6 months
|
Changes from original to final surgical plan.
|
6 months
|
Correlation of serial MRI to clinical and pathological response
Time Frame: 6 months
|
Characterize how the results of serial MRIs affect surgical planning and how the radiological response relates to clinical response and pathological response.
|
6 months
|
Patient reported outcomes assessed by questionnaire
Time Frame: 6 months
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Stephen Chia, MD, BCCA
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H18-02581
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Breast Cancer
-
Northwestern UniversityEisai Inc.UnknownMale Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative...United States
-
Rutgers, The State University of New JerseyNational Cancer Institute (NCI); Rutgers Cancer Institute of New JerseyActive, not recruitingStage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative Breast CancerUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedMale Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
University of WashingtonTerminatedBreast Cancer | Breast Cancer Stage I | Breast Cancer Stage II | Breast Cancer Stage III | Breast Cancer Stage IIB | Breast Cancer Stage IIA | Breast Cancer Stage IIIA | Breast Cancer Stage IIIB | Breast Cancer Stage IIIcUnited States
-
CelgeneCompletedBreast Cancer | Metastatic Breast Cancer | Stage IV Breast Cancer | Triple-negative Breast Cancer | Recurrent Breast Cancer | Breast Tumor | Cancer of the Breast | Triple-negative Metastatic Breast Cancer | Estrogen Receptor- Negative Breast Cancer | HER2- Negative Breast Cancer | Progesterone Receptor- Negative...United States, United Kingdom, Italy, Germany, Spain, Canada, Portugal, Australia, Austria, Greece, Brazil, France
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedHER2-positive Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Estrogen Receptor-negative Breast Cancer | Estrogen Receptor-positive Breast Cancer | Progesterone Receptor-negative Breast Cancer | Progesterone Receptor-positive Breast...United States
-
University of WashingtonNational Cancer Institute (NCI)CompletedHER2-positive Breast Cancer | Male Breast Cancer | Stage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast CancerUnited States
-
Sidney Kimmel Cancer Center at Thomas Jefferson...Susan G. Komen Breast Cancer FoundationCompletedStage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IIIC Breast Cancer | Estrogen Receptor-negative Breast Cancer | Progesterone Receptor-negative Breast Cancer | HER2-negative Breast CancerUnited States
-
University of Southern CaliforniaNational Cancer Institute (NCI)WithdrawnStage IV Breast Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Triple-negative Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIIC Breast Cancer | Recurrent Breast Cancer
Clinical Trials on Intervention 1
-
Texas State UniversityKansas State University; Penn State UniversityUnknownRomantic Relationship Skills | Coparenting Skills
-
Arkansas Children's Hospital Research InstituteRecruiting
-
Hospital Universitario Central de AsturiasRecruiting
-
Hospital Universitari Vall d'Hebron Research InstituteUniversity of Vienna; University of Helsinki; Aalto University; Firstbeat Technologies... and other collaboratorsCompleted
-
Medical University of LodzNational Science Centre, PolandCompletedChronic Obstructive Pulmonary Disease (COPD)Poland
-
Mayo ClinicEnrolling by invitationCommunication | Patient SatisfactionUnited States
-
Fundacio d'Investigacio en Atencio Primaria Jordi...SanofiCompletedType 2 Diabetes MellitusSpain
-
University of WashingtonNational Multiple Sclerosis SocietyCompleted
-
University of FloridaCompletedSensitivityUnited States
-
Jonsson Comprehensive Cancer CenterAmerican Cancer Society, Inc.Completed