PRospective Study to Measure the Impact of MammaPrint on Adjuvant Treatment in Hormone Receptor-positive HER2-negative Breast Cancer Patients (PRIMe)

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02269813
• Date of registration: 14/10/2014
• Prospective Registration: Yes
• Primary sponsor: West German Study Group
• Public title: PRospective Study to Measure the Impact of MammaPrint on Adjuvant Treatment in Hormone Receptor-positive HER2-negative Breast Cancer Patients (PRIMe) PRIMe
• Scientific title: PRospective Study to Measure the Impact of MammaPrint on Adjuvant Treatment in Hormone Receptor-positive HER2-negative Breast Cancer Patients (PRIMe)
• Date of first enrolment: April 1, 2015
• Target sample size: 452
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02269813
• Study type: Observational

Countries of recruitment

Austria, Germany, Switzerland

Contacts

• Name: Nadia Harbeck, Prof. Dr.
• Affiliation: Scientific Director

• Name: Ulrike Nitz, Prof. Dr.
• Affiliation: General Manager/Medical Director

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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

Exclusion Criteria:

- =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



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Breast Cancer

Intervention(s)

Other: MammaPrint

Other: BluePrint

Other: TargetPrint

Primary Outcome(s)

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.]

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.]

Secondary Outcome(s)

Assess concordance of final treatment intention and treatment actually received by number of patients. [Time Frame: Up to 6 months after end of treatment.]

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.]

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 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.]

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.]

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 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 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.]

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.]

Secondary ID(s)

WSG-PRIMe

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Agendia