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

Официальное название

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

Обзор

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.

Подробное описание

The FLEX Registry will include all patients with stage I-III breast cancer who have received MammaPrint and BluePrint testing in any clinical setting. Study arm appendices will specify treatment arm, inclusion criteria, and number of patients needed. Approximately 30,000 patients from 125+ US based institutions will be enrolled.

Treatment is at the discretion of the physician adhering to NCCN approved regimens of a recognized alternative.

Clinical data will be collected and entered online at the time points listed: patient enrollment, time of treatment, 1 year post-treatment, and 3, 5, and 10 years post diagnosis.

Objectives:

* Create a large scale, population-based registry of full genome expression data and clinical data to investigate new gene associations with prognostic and/or predictive value * Utilize shared registry infrastructure to examine smaller groups of interest * Generate hypotheses for targeted subset analyses and trials based on full genome data

FLEX is an observational (phase IV) study.

Вмешательства

• Диагностический тест MammaPrint, BluePrint, and Full-Genome Testing
  Agendia will run MammaPrint and BluePrint tests using the full genome testing array.

Первичные конечные точки

• A large scale registry of full genome expression data to investigate new gene associations with prognostic and/or predictive value will be created. [Срок оценки: 10 years]
• A shared registry infrastructure to examine smaller groups of interest. [Срок оценки: 10 years]

Вторичные конечные точки (1)

• Subset analyses based on full genome data will be created. [Срок оценки: 10 years]

Критерии участия

Критерии включения

• 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

Критерии исключения

• Tumor sample shipped to Agendia with ≤ 30% tumor cells or that fails QA or QC criteria
• Metastatic disease
• Recurrent disease
• Stage 0 disease

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Только случаи

Центры проведения

США · 130 центров

• CHS Grandview — Birmingham
• Providence Alaska Medical Center — Anchorage
• Arizona Oncology Associates, PC — Phoenix
• Arizona Oncology Associates, PC - HOPE — Tucson
• Adventist Health - Bakersfield — Bakersfield
• Comprehensive Cancer Center at Desert Regional Medical Center — Palm Springs
• North Valley Breast Clinic — Redding
• UCSF Breast Care Center — San Francisco
• … и ещё 122 центра

Канада · 2 центра

Список центров уточняется — проверьте первичный протокол.

Греция · 1 центр

Список центров уточняется — проверьте первичный протокол.

Израиль · 1 центр

Список центров уточняется — проверьте первичный протокол.

Публикации

• O'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 f PMID 42341255
• Brufsky 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 PMID 40796181

Идентификаторы

NCT: NCT03053193 · FLEX Registry

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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