Breast CancerERNCT03790813
Informative Tools to Optimize Neoadjuvant Therapy in ER Positive, HER2 Negative Breast Cancers
A study testing Intervention 1 and Intervention 2 in people with Breast Cancer, run by British Columbia Cancer Agency.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 89 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Intervention 1 and Intervention 2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 7 Jan 2019to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Intervention 1, Intervention 2
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention 1Diagnostic test
Ki-67 and Oncotype DX® will be performed on the baseline core biopsy specimen prior to initiation of neoadjuvant systemic therapy.
Intervention 2Diagnostic test
MRI will be performed prior to initiation of neoadjuvant systemic therapy and at the end of treatment.
| Study group | Role | What they receive |
|---|---|---|
| Eligible patients | Experimental | Not described Receives: Diagnostic Test: Intervention 1; Diagnostic Test: Intervention 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month
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
Measured: 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
- 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
Measured: 6 months
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
Measured: 6 months
Secondary outcomes (6)
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).
Measured: 6 months
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.
Measured: 5 years
Predictive association of Ki-67 and Oncotype to overall survival
- Time from enrollment to death from any cause.
Measured: 5 years
Impact of serial MRI on changes to surgical planning
Changes from original to final surgical plan.
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2019
- Study start7 Jan 2019 (estimated)
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- British Columbia Cancer Agency
- Sponsor type
- University, hospital or other
- Collaborators
- Genomic Health®, Inc.
- Responsible party
- Principal investigator, Stephen Chia, British Columbia Cancer Agency
- Investigators
- Stephen Chia, MD, Principal investigator, BCCA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03790813
- Sponsor's protocol ID
- H18-02581
- Acronym
- ER
- Status last verified
- Dec 2018
- First submitted
- 30 Nov 2018
- Last updated
- 2 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Informative Tools to Optimize Neoadjuvant Therapy in ER Positive, HER2 Negative Breast Cancers
- ClinicalTrials.gov ID
- NCT03790813
- Acronym / sponsor ID
- ER / H18-02581
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- British Columbia Cancer AgencyUniversity, hospital or other
- Collaborators
- Genomic Health®, Inc.
- Study start
- 7 Jan 2019 (estimated)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 2 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eligible patients | Experimental | Diagnostic Test: Intervention 1, Diagnostic Test: Intervention 2 |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention 1Ki-67 and Oncotype DX® will be performed on the baseline core biopsy specimen prior to initiation of neoadjuvant systemic therapy. | Diagnostic test | Eligible patients |
| Intervention 2MRI will be performed prior to initiation of neoadjuvant systemic therapy and at the end of treatment. | Diagnostic test | Eligible patients |
Primary outcome
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.
Turnaround time of Ki-67 and Oncotype DX, defined as time from patient consent to date results are obtained
Time frame: 1 month
* Turnaround time will be defined as: * Time from patient consent to reporting of the Ki-67 and Oncotype DX
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
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 secondary outcomes
Correlation of Ki-67 and Oncotype DX to each other and to the outcome of neoadjuvant systemic treatment.
Time frame: 6 months
Predictive association of Ki-67 and Oncotype to invasive locoregional or systemic relapse
Time frame: 5 years
Predictive association of Ki-67 and Oncotype to overall survival
Time frame: 5 years
Impact of serial MRI on changes to surgical planning
Time frame: 6 months
Correlation of serial MRI to clinical and pathological response
Time frame: 6 months
Patient reported outcomes assessed by questionnaire
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Chia, MD principal investigator
BCCA
Questions about this trial
What is this clinical trial studying?
A study testing Intervention 1 and Intervention 2 in people with Breast Cancer, run by British Columbia Cancer Agency.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nathalie LeVasseur, MD (604-877-6000x2734, nathalie.levasseur@bccancer.bc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of neoajduvant Ki-67 and Oncotype DX, defined as >=75% enrollment rate for all screened patients (time frame: 1 month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2019.