Clinical Trial Portfolio

  • Protocol and (e)CRF development
  • Study execution
  • Statistical analyses
  • Publication of results

Phase 4: Impact studies

PROMMIS: PRospective Observational Multiple Myeloma Impact Study to measure the impact of MMprofiler on treatment intention in active multiple myeloma patients (NCT02911571)

  • Status Jan 2020: >150 patients enrolled from 9 sites (Target 250)
  • Hari et al, Poster Presentation ASCO 2019
  • Hari et al, Poster Presentation EHA 2019

Measuring the Impact of MammaPrint on Adjuvant and neo-adjuvant treatment decisions in breast Cancer patients: a prospective registry (IMPACt) (NCT02670577)

  • Enrollment completed (481 patients in 17 US sites in 1,5 years)
  • Status: Published (Soliman et al, BMC Cancer 2020)

PRospective study to measure the Impact of MammaPrint on adjuvant treatment in hormone receptor-positive HER2-negative breast cancer patients (PRIMe) (Prof N. Harbeck) (NCT02911571)

  • Enrollment completed (427 patients in 27 DE, AT and CH sites in 1 year)
  • Status: Published (Wuerstlein et al, BCRT 2019)

The Symphony Triple A study: using Symphony as an Adjunct to histopathologic parameters when the doctor is Ambivalent about the Administration and type of adjunctive systemic therapy (PI Dr T van Dalen) (NCT02209857)

  • Enrollment completed (660 patients in 33 NL sites in 2 years)
  • Status: published (Kuijer et al, JCO 2017)

PRospective Study Of MammaPrint in Patients With an Intermediate Recurrence Score (PROMIS) (NCT01617954)

  • Enrollment completed (840 patients in 58 US sites in 3,5 years)
  • Status: published (Tsai et al, JAMA Oncol 2018)

A Prospective Study for the Assessment of Recurrence Risk in Stage II Colon Cancer Patients Using ColoPrint (PARSC) (NCT00903565)

  • Target: 210 Patients within 2,5 years in 10 EU and US sites
  • Status: Study cancelled by sponsor

Phase 4: registry studies

NBREaSTII: European Prospective neo-adjuvant REGISTRY trial linking MammaPrint, Subtyping and treatment response

  • Enrollment completed (257 patients in 16 sites in 4 years)
  • Status: Pending publication

MINTI: Multi-Institutional Neo-adjuvant Therapy MammaPrint Project I (NCT01501487)

  • Enrollment completed (227 patients in 9 sites in 4 years)
  • Status May 2018: Pending publication

NBRST: Prospective Neo-adjuvant REGISTRY Trial (PI Dr P Whitworth) (NCT01479101)

  • Enrollment completed (1200 patients in 35 sites in 2,5 years)
  • Whitworth et al, Ann Surg Oncol 2017
  • Beitsch et al, Ann Surg Oncol 2017
  • Baron et al, Ann Sug Oncol 2016
  • Whitworth et al, Ann Surg Oncol, 2014

The Study of Molecular Risk Panels in Chinese Breast Cancer Patient using Mammaprint, TargetPrint, BluePrint and Research Gene Panel assays. (PI Dr A Kwong)

  • Status: Ongoing (100 patients in 1 site in Hong Kong)

European inter-institutional impact study of MammaPrint (PI Dr P Cusumano).

  • Enrollment completed (194 patients in 3 sites in NL, IT and ES in 2 years)
  • Status: published (Breast 2014)

MammaPrint in Women with Uncertain Benefit of Chemotherapy after Breast Cancer Surgery (PI P Dubsky)

  • Enrollment completed (75 patients in 1 Austrian site in 2 years)
  • Status: published (BJC 2014)

MP090: MammaPrint and TargetPrint Implementation Project

  • Enrollment completed (1294 patients in 37 sites around the world in 4 years)
  • Status: published

 Phase 3

MINDACT  (Microarray In Node-negative and 1 to 3 positive lymph node Disease may Avoid ChemoTherapy):  A prospective, randomized study comparing the 70-gene signature with the common clinicalpathological criteria in selecting patients for adjuvant chemotherapy in breast cancer with 0 to 3 positive nodes. (PI Dr M Piccart, Dr F Cardoso, Dr E Rutgers) (NCT00433589)

  • Status: Enrollment completed (6697 patients in 111 European sites in 4 years)
  • Status: published (NEJM 2016)

 Phase 2

A Prospective Study for the Assessment of Recurrence Risk in Stage II Colon Cancer Patients Using ColoPrint (PARSC) (NCT00903565)

  • Enrollment blinded phase completed (536 patients from 31 institutes in Europe, USA, and Asia in 4 years).

A Randomized, Placebo-Controlled, Double-Blind Phase 2 Study of Gemcitabine Plus LY293111 Compared to Gemcitabine Plus Placebo in Patients With Locally Advanced or Metastatic Pancreatic Cancer (NCT00055250)

  • Enrollment completed (130 patients in multiple sites around the world in 3 years)
  • Status: published (Cancer 2009)

Phase 1

An Open-label, Multi-Center. Dose-finding Study to Evaluate the Safety and Tolerability of AMG 706, Panitumumab and a combination of AMG 706 and Panitumumab when Administered with Induction Chemotherapy (IC) and/or Chemo-radiotherapy (CRT) in the Treatment of Subjects with Loco-regionally Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN) (PI: Dr J Baselga)

  • Status: clinical study report published on Amgen website

A phase I/II trial of a P-glycoprotein inhibitor, Zosuquidar.3HCl trihydrochloride (LY335979), given orally in combination with the CHOP regimen in patients with non-Hodgkin’s lymphoma (PI: Dr F. Morschhauser F, Dr C. Dumontet)

  • Status: published (Leuk Lymphoma. 2007)