Breast CancerPRIMeNCT02269813
PRospective Study to Measure the Impact of MammaPrint on Adjuvant Treatment in Hormone Receptor-positive HER2-negative Breast Cancer Patients (PRIMe)
An observational study of Breast Cancer, run by Women's Cancer Study Group GmbH at 3 sites in 3 countries.
Trial summary
PRIMe is a prospective, case-only trial designed to measure the impact of MammaPrint on physician chemotherapy intention in the two discordant groups (ET/POOR, CT/GOOD) in stage 1 and 2 HR-positive HER2-negative breast cancer patients. The design also provides for assessment of several important secondary indicators. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- MammaPrint, BluePrint and TargetPrint
- How many people
- 452 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 1 Apr 2015to 30 Sep 2016
- Phase
- Observational
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The study population will comprise patients for whom the investigator will advise either endocrine therapy or chemotherapy + endocrine therapy. Patients confirmed to be low/high risk by the gene signature will receive the respective treatment. Patients with discordant results will be investigated for investigator's chemotherapy intention after MammaPrint results are available.
Who may be able to join
- Women with histologically proven invasive stage 1 and 2 breast cancer
- Hormone receptor positive according to local standards
- HER2 negative - i.e. IHC 0-1+, or FISH or other ISH non-amplified (locally assessed)
- Axillary lymph node status: 0-3 involved (macro metastases i.e. >2mm OR micro metastases i.e. >0.2-2mm)
- ≥ 18 years of age at time of consent
- Patients must be eligible to receive adjuvant chemotherapy and endocrine therapy as defined by a good Karnofsky index, no hematological, cardiological or hepatic contraindications nor any impeding comorbidity
- Written informed consent
Who cannot join
- ≥4 involved axillary nodes
- Multi-centric disease with more than 2 clinically relevant lesions
- HR negative OR HER2 positive/amplified (locally assessed)
- Previous diagnosis of malignancy unless disease free for 10 years
- Metastatic disease
- Tumor sample shipped to Agendia with ≤ 30% tumor cells or that fails QA or QC criteria
- Women who have started or completed adjuvant chemotherapy or neo-adjuvant chemotherapy for current breast cancer
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Austria1 site
Medizinische Universität Innsbruck Universitätsklinik für Frauenheilkunde
Innsbruck, 6020
About this study
PRIMe is a prospective, case-only trial designed to measure the impact of MammaPrint on physician chemotherapy intention in the two discordant groups (ET/POOR, CT/GOOD) in stage 1 and 2 HR-positive HER2-negative breast cancer patients. The design also provides for assessment of several important secondary indicators. Eligible patients will have their tumor sample analyzed for MammaPrint, BluePrint and TargetPrint. Patients cannot start treatment before the MammaPrint result is received and taken into consideration for the adjuvant treatment plan.
- Conditions
- Breast Cancer
- Being tested
- MammaPrint, BluePrint, TargetPrint
- Keywords
- MammaPrint, BluePrint, TargetPrint
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MammaPrintOther
BluePrintOther
TargetPrintOther
| Study group | Role | What they receive |
|---|---|---|
| ET/GOOD | Endocrine therapy only. Receives: Other: MammaPrint; Other: BluePrint; Other: TargetPrint | |
| CT/POOR | Chemoendocrine therapy according to national guidelines. Receives: Other: MammaPrint; Other: BluePrint; Other: TargetPrint |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure the impact of MammaPrint on adjuvant treatment decisions in discordant groups (ET/POOR and CT/GOOD) in stage-1/2, HR+, HER2- breast cancer and test whether these impacts each exceed a pre-determined compliance threshold.
Compliance, assessed in terms of the fraction of patients in each discordant group whose physicians switch their chemotherapy intention following MammaPrint test disclosure is used to measure the impact of MammaPrint on adjuvant treatment decisions.
Measured: Up to 6 months after end of treatment.
Assess the incremental cost-effectiveness of MammaPrint in terms of cost and quality-adjusted life years within a health economic context using the impacts measured in this trial as well as the predictive impact demonstrated in previous trials.
Measured: Up to 6 months after end of treatment.
Secondary outcomes (11)
Measure the impacts of MammaPrint on adjuvant treatment decisions (physician chemotherapy intention) and compare with previous trials involving MammaPrint or other tests.
The planned analysis includes assessment of the incremental cost-effectiveness (ICER) of MammaPrint within a health economic context (i.e., taking cost and quality-adjusted life years into account).
Measured: Up to 6 months after end of treatment.
Measure rate (by incidence) and severity (by Common Toxicity Criteria) of treatment-related serious adverse events stratified by whether or not patient received adjuvant chemotherapy.
Measured: Up to 6 months after end of treatment.
Assess change in patients' decisional conflict status and anxiety levels before and after MammaPrint results via questionnaire, stratified by the four groups (2 concordant and 2 discordant).
Measured: Up to 6 months after end of treatment.
Assess investigators' confidence in treatment recommendations before and after MammaPrint results were known via questionnaire.
Measured: Up to 6 months after end of treatment.
Assess concordance of final treatment intention and treatment actually received by number of patients.
Measured: Up to 6 months after end of treatment.
Assess concordance of TargetPrint ER, PR and HER2 results with locally assessed IHC/FISH ER, PR and HER2 by number of patients.
Measured: Up to 6 months after end of treatment.
Compare clinical subtype based on IHC/FISH ER, PR, HER2 and Ki-67 (St Gallen 2013) with BluePrint molecular subtype by diagnostic definition of subtype.
Measured: Up to 6 months after end of treatment.
Assess concordance of MammaPrint, BluePrint and TargetPrint in multi-centric breast cancer by number of patients.
Measured: Up to 6 months after end of treatment.
Assess the combined switch rate in the two concordant groups (ET/GOOD) and (CT/POOR) and verify that it is lower than the switch rate in both discordant groups by number of patients.
Measured: Up to 6 months after end of treatment.
Perform descriptive sub-analysis in pre- and post-menopausal women by switch percentages.
Measured: Up to 6 months after end of treatment.
Perform cross-validation with other adjuvant breast cancer studies by switch rate, if available.
Measured: Up to 6 months after end of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2014 (estimated)
- Study start1 Apr 2015
- Primary completion31 Mar 2016
- Study completion30 Sep 2016
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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 452 participants (actual)
Sponsor and investigators
- Lead sponsor
- Women's Cancer Study Group GmbH
- Sponsor type
- University, hospital or other
- Collaborators
- Agendia
- Responsible party
- Sponsor
- Investigators
- Nadia Harbeck, Prof. Dr., Principal investigator, Scientific DirectorUlrike Nitz, Prof. Dr., Study chair, General Manager/Medical Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02269813
- Sponsor's protocol ID
- WSG-PRIMe
- Acronym
- PRIMe
- Status last verified
- Aug 2019
- First submitted
- 14 Oct 2014
- Last updated
- 13 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRospective Study to Measure the Impact of MammaPrint on Adjuvant Treatment in Hormone Receptor-positive HER2-negative Breast Cancer Patients (PRIMe)
- ClinicalTrials.gov ID
- NCT02269813
- Acronym / sponsor ID
- PRIMe / WSG-PRIMe
- Conditions
- Breast Cancer
- Keywords
- MammaPrint, BluePrint, TargetPrint
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 452 participants (actual)
- Lead sponsor
- Women's Cancer Study Group GmbHUniversity, hospital or other
- Collaborators
- Agendia
- Study start
- 1 Apr 2015 (actual)
- Primary completion
- 31 Mar 2016 (actual)
- Study completion
- 30 Sep 2016 (actual)
- First posted
- 21 Oct 2014 (estimated)
- 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.
PRIMe is a prospective, case-only trial designed to measure the impact of MammaPrint on physician chemotherapy intention in the two discordant groups (ET/POOR, CT/GOOD) in stage 1 and 2 HR-positive HER2-negative breast cancer patients. The design also provides for assessment of several important secondary indicators. Eligible patients will have their tumor sample analyzed for MammaPrint, BluePrint and TargetPrint. Patients cannot start treatment before the MammaPrint result is received and taken into consideration for the adjuvant treatment plan.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ET/GOOD | – | Other: MammaPrint, Other: BluePrint, Other: TargetPrintEndocrine therapy only. |
| CT/POOR | – | Other: MammaPrint, Other: BluePrint, Other: TargetPrintChemoendocrine therapy according to national guidelines. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will comprise patients for whom the investigator will advise either endocrine therapy or chemotherapy + endocrine therapy. Patients confirmed to be low/high risk by the gene signature will receive the respective treatment. Patients with discordant results will be investigated for investigator's chemotherapy intention after MammaPrint results are available.
Key inclusion criteria (7 listed)
- Women with histologically proven invasive stage 1 and 2 breast cancer
- Hormone receptor positive according to local standards
- HER2 negative - i.e. IHC 0-1+, or FISH or other ISH non-amplified (locally assessed)
- Axillary lymph node status: 0-3 involved (macro metastases i.e. >2mm OR micro metastases i.e. >0.2-2mm)
- ≥ 18 years of age at time of consent
Key exclusion criteria (7 listed)
- ≥4 involved axillary nodes
- Multi-centric disease with more than 2 clinically relevant lesions
- HR negative OR HER2 positive/amplified (locally assessed)
- Previous diagnosis of malignancy unless disease free for 10 years
- Metastatic disease
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 |
|---|---|---|
| MammaPrint | Other | CT/POOR, ET/GOOD |
| BluePrint | Other | CT/POOR, ET/GOOD |
| TargetPrint | Other | CT/POOR, ET/GOOD |
Primary outcome
Measure the impact of MammaPrint on adjuvant treatment decisions in discordant groups (ET/POOR and CT/GOOD) in stage-1/2, HR+, HER2- breast cancer and test whether these impacts each exceed a pre-determined compliance threshold.
Time frame: Up to 6 months after end of treatment.
Compliance, assessed in terms of the fraction of patients in each discordant group whose physicians switch their chemotherapy intention following MammaPrint test disclosure is used to measure the impact of MammaPrint on adjuvant treatment decisions.
Assess the incremental cost-effectiveness of MammaPrint in terms of cost and quality-adjusted life years within a health economic context using the impacts measured in this trial as well as the predictive impact demonstrated in previous trials.
Time frame: Up to 6 months after end of treatment.
11 secondary outcomes
Measure the impacts of MammaPrint on adjuvant treatment decisions (physician chemotherapy intention) and compare with previous trials involving MammaPrint or other tests.
Time frame: Up to 6 months after end of treatment.
Measure rate (by incidence) and severity (by Common Toxicity Criteria) of treatment-related serious adverse events stratified by whether or not patient received adjuvant chemotherapy.
Time frame: Up to 6 months after end of treatment.
Assess change in patients' decisional conflict status and anxiety levels before and after MammaPrint results via questionnaire, stratified by the four groups (2 concordant and 2 discordant).
Time frame: Up to 6 months after end of treatment.
Assess investigators' confidence in treatment recommendations before and after MammaPrint results were known via questionnaire.
Time frame: Up to 6 months after end of treatment.
Assess concordance of final treatment intention and treatment actually received by number of patients.
Time frame: Up to 6 months after end of treatment.
Assess concordance of TargetPrint ER, PR and HER2 results with locally assessed IHC/FISH ER, PR and HER2 by number of patients.
Time frame: Up to 6 months after end of treatment.
Compare clinical subtype based on IHC/FISH ER, PR, HER2 and Ki-67 (St Gallen 2013) with BluePrint molecular subtype by diagnostic definition of subtype.
Time frame: Up to 6 months after end of treatment.
Assess concordance of MammaPrint, BluePrint and TargetPrint in multi-centric breast cancer by number of patients.
Time frame: Up to 6 months after end of treatment.
Assess the combined switch rate in the two concordant groups (ET/GOOD) and (CT/POOR) and verify that it is lower than the switch rate in both discordant groups by number of patients.
Time frame: Up to 6 months after end of treatment.
Perform descriptive sub-analysis in pre- and post-menopausal women by switch percentages.
Time frame: Up to 6 months after end of treatment.
Perform cross-validation with other adjuvant breast cancer studies by switch rate, if available.
Time frame: Up to 6 months after end of treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2019.
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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.
Nadia Harbeck, Prof. Dr. principal investigator
Scientific Director
Ulrike Nitz, Prof. Dr. study chair
General Manager/Medical Director
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Women's Cancer Study Group GmbH at 3 sites in 3 countries.
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 7 inclusion and 7 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: finished, as of the sponsor's last update on 13 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Austria, Germany, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure the impact of MammaPrint on adjuvant treatment decisions in discordant groups (ET/POOR and CT/GOOD) in stage-1/2, HR+, HER2- breast cancer and test whether these impacts each exceed a pre-determined compliance threshold. (time frame: Up to 6 months after end of treatment.). The study lists 2 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 13 Aug 2019.