Breast

10054 (LAPATAX)

• Project ongoing
  ERP 307: Long-term follow-up to be included in CTNeoBC pCR meta-analysis in HER2+ trials (project leader: H. Bonnefoi)
  Status: Database transferred to external group.

10981 (AMAROS)

• Project under finalization/finalized
  RP 1463 (SNB nomogram): Predicting Sentinel Node Positivity using data of the EORTC 10981-22023 AMAROS trial: who can be spared sentinel lymph node biopsy (project leader: E. Rutgers)
  Status: Finalized (presented at EORTC-BCG meeting in Paris, Sept 2017).

10085 (MALE BC)

• Projects under development
  ERP 277: Pathology biomarkers of Male BC (project leader: J. Bartlett)
  Status: Database to be transferred.
• Projects ongoing
  • RP 1539 (RNAseq): Male breast cancer RNA sequencing (Project leader: J. Martens)
    Status: Analyses of first 73 patients completed, presented at SABCS 2017 (poster spotlight). Additional analyses to follow.
  • RP 1703 (BCRF2016 Grant: NANOSTRING/SETER-PR): International Male Breast Cancer Program of EORTC/TBCRC/BIG/NABCG : understanding the biology for improved patient care. In research of valuable biomarkers (Project leaders: F. Cardoso, J. Bartlett and F. Symmans)
    Status: Samples currently analysed.
• Project under finalization/finalized
  Male BC Precursor lesions (project leader: C. van Deurzen)
  Status: Manuscript published in Modern Pathology in 2017.

10041 (MINDACT)-related projects

• Projects under development
  • RP 18XX (positive node): Genomic risk as an aid to treatment decisions in patients with positive sentinel lymph nodes and conservative management of the axilla (no axillary dissection) (Project leaders: A. Sonnenblick, M. Lambertini)
    Status: project approved.
  • RP 1550 (MINDACT Relapses): Dissecting the pathways of therapy resistance in early breast cancer: A substudy of the EORTC 10041/BIG 3-04 MINDACT study. (Project leaders: F. Cardoso, M. Piccart, E. Rutgers, G. Viale, L. Van’t Veer, K. Aalders, C. Desmedt)
    Status: Substudy under protocol review.
  • ERP 282 (MINDACT SCNA/ Immune on silico): Investigation of the downstream effect of somatic copy number alterations (SCNAs) on gene expression levels in relation to clinic-pathological variables / Prognostic value of in silico immune phenotypes in the MINDACT trial (Project leaders: C. Sotiriou, R. Fehrmann)
    Status: Data transfer agreement signed. Awaiting Ethical Committee approval.
  • ERP XXX (MINDACT BMI): Characterization of the body mass index (BMI), its effect on recurrence dynamics and tumor transcriptomics in the MINDACT trial. (Project leaders: C. Desmedt, E. Senkus-Konefka)
    Status: Data transfer agreement under signature. Clinical data ready to be transferred, genomic data pending.
  • ERP XXX (MINDACT FGFR1/CCND1): Fine tuning Mammaprint with DNA-based approaches: prognostic value of FGFR1/CCND1 amplifications in patients with luminal high risk BC (Project leaders: F. Andre, S. Michiels)
    Status: Project approved. Contract under negotiation.
  • ERP XXX (MINDACT cRNA): Leveraging cancer-specific circulating RNAs for early detection of breast cancer in liquid biopsies (Project leaders: H. Goodarzi, H. Asgharian)
    Status: Project approved, on hold until reassessment of sample availability.
• Projects ongoing
  • RP 1761 (MINDACT Integrated model): Assessing the prognostic value of MammaPrint on top of Traditional Clinical/Pathologic Criteria (Project leader: F. Cardoso).
    Status: Ongoing.
  • RP 1806 (MINDACT Biological heterogeneity): Understanding the biological heterogeneity of HER-2 positive breast cancer (Project leader: F. Cardoso)
    Status: Ongoing.
  • ERP 262 (MINDACT iCOGS): Associations of iCOGS germline variants with clinico-pathological and expression data in the MINDACT study (Project leader: M. Schmidt)
    Status: Clinical database transferred to external investigator in April 2017, genomic data pending
  • ERP XXX (MINDACT EBCTCG): 7th cycle (2015-2020) overview of randomised trials in early breast cancer (EBCTCG) (Project leader: E. Rutgers)
    Status: Contract under signature. Data ready to be transferred.
• Projects under finalization/finalized
  • RP 1718 (MINDACT Loco-regional recurrences): Prognostic value of the 70-gene signature for locoregional breast cancer recurrence in the EORTC 10041/BIG 3-04 (MINDACT) trial (Project leaders: E. Rutgers, K. Aalders).
    Status: Project presented at EBCC 2018 as oral presentation.
  • RP 1717 (MINDACT Young): The use of 70-gene signature in young women with early stage breast cancer-a subgroup analysis from the EORTC 10041/BIG 03-04 MINDACT trial (Project leader: K. Aalders).
    Status: Project presented at SABCS 2017 (poster). Manuscript under preparation.
  • RP 1465 (MINDACT Small tumors): Characterization of patients with small size invasive breast tumors with no axillary lymph nodal involvement: A subset analysis of patients with T1a,bN0 tumors enrolled in the MINDACT trial. (Project leader: K. Tryfonidis)
    Status: Project presented at ESMO 2017 (press release and oral presentation). Manuscript finalized, to be submitted to Breast.
  • RP 1464 (MINDACT Survey): A survey among Mindact investigators on their current opinion regarding chemotherapy administration (Project leaders: C. Drukker and J. Lopes Cardozo)
    Status: Two questionnaires submitted to investigators. One was analyzed and presented at IMPAKT 2015 (poster). The second questionnaire will be analyzed in Q3-Q4 2018.
  • ERP 265 (MINDACT cost-effectiveness): Cost-effectiveness Analysis of the MammaPrint based on MINDACT results (Project leader: V. Retel)
    Status: Project presented as poster at SABCS 2017. Further analysis ongoing.
  • RP 1556 (MINDACT multifocal): Characterisation of multifocal disease in the MINDACT study (Project leaders: E. Rutgers, A. Kuijer, M. Straver, K. Aalders).
    Status: Manuscript published in European Journal of Cancer in 2017.
  • RP 0907 (TargetPrint): Comparison of microarray readout with IHC/FISH for ER/PR/HER2 (Project leaders: F. de Snoo, L. Stork-Sloots)
    Status: Manuscript published in Breast Cancer Res Treat 2016.
  • RP 0906 (Blue Print): comparison of microarray readout with IHC/FISH for to molecular subtyping profile (BluePrint) (Project leaders: F. Cardoso, G. Viale, F. de Snoo, L. Russo, L. Stork-Sloots)
    Status: Manuscript published in Breast Cancer Res Treat 2017.
  • ERP 179 (MINDACT Lifestyle questionnaire): Association of established breast cancer reproductive and lifestyle risk factors with tumour subtype defined by the prognostic 70-gene expression signature (MammaPrint® (Project leaders: M.Schmidt, C.Drukker)
    Status: Manuscript published in European Journal of Cancer in 2017

10994 (p53)-related projects

• Projects ongoing
  • RP 1432 (LINE): Improving outcomes with Next generation sequencing Experiments of the residual disease after neoadjuvant chemotherapy. (project leader: H. Bonnefoi).
    Status: Ongoing.
  • RP 1476: Pooled analysis of prognostic factors of relapse after pCR in neoadjuvant chemotherapy for early breast cancer. (Project leader: H. Bonnefoi).
    Status: Ongoing.
  • ERP 290 (p53 BMI): BMI and site of relapse (project leader: C. Desmedt)
    Status: Database transferred to external investigator.
  • ERP 319: Concomitant medication in p53 (project leader: A.S. Hamy)
    Status: Database transferred to external investigator.
• Projects under finalization/finalized
  • RP 1646 (p53- Site first distant relapse): Association between pCR status and site of first distant relapse after surgery in patients with a distant relapse: a substudy of the EORTC 10994/BIG1-00 trial. (project leader: K. Aalders)
    Status: Manuscript accepted in Breast Cancer Research and Treatment in January 2018 .
  • RP 1644 (p53-LocoReg): Predictive factors of locoregional recurrence after neoadjuvant chemotherapy in locally advanced breast cancer: a retrospective analysis of the EORTC 10994/BIG1-02 study (Project leader: H. Bonnefoi)
    Status: Manuscript published in European Journal of Cancer in 2017.
  • RP 1543 (Molecular Apocrine): pathological response and clinical outcomes of molecular apocrine tumors in EORTC 10994/BIG 1-00 phase III study identified by central assessment using a tissue microarray construct (project leader: H. Bonnefoi).
    Status: Manuscript under preparation.
  • RP 1480 IRF7 and severe infection: Correlation between severe infection and breast cancer metastases in the EORTC TP53 trial: investigating innate immunity as a tumor suppressor in breast cancer (project leaders: S.Loi, H.Bonnefoi, D.Cameron)
    Status: Manuscript published in European Journal of Cancer in 2017.
  • RP Patterns of relapse after pCR (project leaders: H.Bonnefoi, D.Cameron)
    Status: Manuscript published in European Journal of Cancer in 201 5.
  • RP Role of selected gene polymorphisms on response to neo-adjuvant chemotherapy and survival of breast cancer patients (project leaders: J.Robert, H.Bonnefoi).
    Status: Manuscript published in Pharmacogenomics in 201 5.
  • RP Molecular subtypes: Pathological complete response after neoadjuvant chemotherapy is an independent predictive factor irrespective of simplified breast cancer intrinsic subtypes (project leaders: H.Bonnefoi)
    Status: Manuscript published in Annals of Oncology in 2014 .
  • ERP 215: Causal Inference (project leader: S. Vandenberghe)
    Status: Manuscript published in Statistical Methods in Medical Research in April 2017 .