Clinical trial · Observational
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MammaPrint, BluePrint, and Full-Genome Testing | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- MammaPrint and BluePrint testing
- description
- All patients will receive MammaPrint and BluePrint testing using the full-genome testing data chip. Treatment will be at the discretion of the physician while adhering to NCCN guidelines.
- interventionNames
- Diagnostic Test: MammaPrint, BluePrint, and Full-Genome Testing
Primary outcomes (2)
- measure
- A large scale registry of full genome expression data to investigate new gene associations with prognostic and/or predictive value will be created.
- timeFrame
- 10 years
- description
- Create a large scale registry of full genome expression data with clinical data to investigate possible new gene associations with prognostic or predictive value.
- measure
- A shared registry infrastructure to examine smaller groups of interest.
- timeFrame
- 10 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDO'Shaughnessy J, Brufsky AM, Layeequr Rahman R, Osborne CR, Mahtani R, Elkhanany A, Graham CL, Brown E, Gold LP, Johnson N, Giffoni D, Alberty-Oller JJ, Ramaswamy H, Weber R, Chmielewski-Stivers N, Menicucci AR, Audeh W. Prediction of Anthracycline Benefit in Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Early-Stage Breast Cancer by the MammaPrint 70-Gene Signature for Patients Enrolled in the FLEX Study. JCO Precis Oncol. 2026 Jun;10(6):e2501285. doi: 10.1200/PO-25-01285. Epub 2026 Jun 24. PMID 42341255
- DERIVEDBrufsky AM, Hoskins KF, Conter HJ, Kelemen P, Habibi M, Samian L, Rahman RL, Lee L, Dias EC, Hampton R, Sieling BA, Osborne CR, Brown E, Elayoubi JA, Sharma P, Ramadurai J, Matt-Amaral L, Santillan AA, Davis S, Albaneze P, Ramaswamy H, Chmielewski-Stivers N, Menicucci A, Audeh W, Whitworth P, Johnson N, O'Shaughnessy J. MammaPrint predicts chemotherapy benefit in HR+HER2- early breast cancer: FLEX Registry real-world data. JNCI Cancer Spectr. 2025 Sep 1;9(5):pkaf079. doi: 10.1093/jncics/pkaf079. PMID 40796181