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MammaPrint, BluePrint, and Full-genome Data Linked With Clinical Data to Evaluate New Gene EXpression Profiles

MammaPrint, BluePrint, and Full-genome Data Linked With Clinical Data to Evaluate New Gene EXpression Profiles: An Adaptable Registry (FLEX)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

The FLEX Registry collects gene test results and health data to study new patterns of gene activity in breast cancer. It is for men and women with new stage I, II, or III breast cancer who have MammaPrint testing, with or without BluePrint testing.

The FLEX Registry will be implemented to operate as a large-scale, population based, prospective registry. All patients with stage I to III breast cancer who receive MammaPrint® and BluePrint testing on a primary breast tumor are eligible for entry into the FLEX Registry, which is intended to enable additional study arms at low incremental effort and cost. FLEX Registry will utilize an adaptive design, where additional targeted substudies and arms can be added after the initial study is opened.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have stage I, II, or III breast cancer.
  • Have MammaPrint testing, with or without BluePrint testing.
  • Be male or female.
  • Sign a consent form on or before the day you join.
  • Have a new breast tumor, not cancer that has come back.

Who can't join

  • The tumor sample sent to Agendia has 30% or fewer tumor cells or does not pass quality checks.
  • Have cancer that has spread to distant parts of the body.
  • Have cancer that has come back.
  • Have stage 0 breast cancer.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Stage I, II, or III patients who receive MammaPrint, with or without BluePrint testing (male or female) * Informed consent form signed on the same day or before enrollment * New primary lesion Exclusion Criteria: * Tumor sample shipped to Agendia with ≤ 30% tumor cells or that fails QA or QC criteria * Metastatic disease * Recurrent disease * Stage 0 disease

Study sites (130)

AK

AL

AZ

CA

CO

CT

DE

FL

GA

IL

IN

LA

MA

MD

ME

MI

MN

MO

NY

OH

OK

OR

PA

SC

TN

TX

UT

WA

WI