Newsletter No1 / July 2024
1) The third on-site meeting was held on 27 May 2024 in Athens, Greece.
2) Poster presentations in Trials in Progress category: (i) ESMO Breast 2024 (15 – 17 May) presented by Antonios Valachis (ii) ASCO 2024 (30 May – 3 June) presented by Paris Kosmidis and Thanos Kosmidis
3) A paper based on IMPORTANT project deliverable was recently published: Karihtalaa P, Schiza A, Fountzilas E, Geisler J, Meattini I, Risi E, Biganzoli L, and Valachis A. Clinical trials in older patients with cancer– typical challenges, possible solutions, and a paradigm of study design in breast cancer. Acta Oncologica 2024; 63: 441–447
2) Poster presentations in Trials in Progress category: (i) ESMO Breast 2024 (15 – 17 May) presented by Antonios Valachis (ii) ASCO 2024 (30 May – 3 June) presented by Paris Kosmidis and Thanos Kosmidis
3) A paper based on IMPORTANT project deliverable was recently published: Karihtalaa P, Schiza A, Fountzilas E, Geisler J, Meattini I, Risi E, Biganzoli L, and Valachis A. Clinical trials in older patients with cancer– typical challenges, possible solutions, and a paradigm of study design in breast cancer. Acta Oncologica 2024; 63: 441–447
Newsletter No2 / August 2024
1) Three patients in Helsinki and one patient in Örebro have completed their first 3-month follow up
2) The amendment of the IMPORTANT trial protocol regarding some of the inclusion and exclusion criteria is ready for submission (see below in bold)
3) The inclusion criterion on RECIST assessment has been removed 4) The changes in the exclusion and inclusion criteria are to allow a broader patient inclusion and to serve the pragmatic scope of the trial. These changes have no impact on the informed consent form (ICF)
2) The amendment of the IMPORTANT trial protocol regarding some of the inclusion and exclusion criteria is ready for submission (see below in bold)
3) The inclusion criterion on RECIST assessment has been removed 4) The changes in the exclusion and inclusion criteria are to allow a broader patient inclusion and to serve the pragmatic scope of the trial. These changes have no impact on the informed consent form (ICF)
Newsletter No3 / September 2024
1) Five patients have completed their first 3-month follow up
2) IMPORTANT trial clinical lead, Antonios Valachis, will be attending the first meeting for Horizon Europe Cancer Mission ‘Diagnosis and Treatment’ cluster in Barcelona, Spain on 12 September 2024. IMPORTANT trial is one of the 12 funded projects under the cluster. Antonis will be chairing the round table discussion on `Addressing Inequalities´
2) IMPORTANT trial clinical lead, Antonios Valachis, will be attending the first meeting for Horizon Europe Cancer Mission ‘Diagnosis and Treatment’ cluster in Barcelona, Spain on 12 September 2024. IMPORTANT trial is one of the 12 funded projects under the cluster. Antonis will be chairing the round table discussion on `Addressing Inequalities´
Newsletter No4 / October 2024
1) Six patients have completed their first 3-month follow up
2) Clinical sites in Greece have received conditional approval from CTIS
3) The project will request for an extension of inclusion period from 30 months to 36 months, and one year extension
4) Abstract to San Antonio Breast Cancer Symposium (SABCS) 2024 has been accepted for trial in progress poster
5) Prof. Biganzoli presented IMPORTANT as part of her presentation on “MDT– case of an older adult with metastatic breast cancer´´ during ESMO 2024
6) The trial clinical lead, Assoc. Prof. Antonios Valachis, attended the 1st meeting for Horizon Europe Cancer Mission ‘Diagnosis and Treatment’ cluster in Barcelona, Spain on 12 September 2024
7) The project participated at the EU Researcher’s Night event in Nicosia, Cyprus on 27 September 2024, led by Dr Vasiliki Danilatou and Assoc. Prof. Christiana Markou from Eunomia Ltd
2) Clinical sites in Greece have received conditional approval from CTIS
3) The project will request for an extension of inclusion period from 30 months to 36 months, and one year extension
4) Abstract to San Antonio Breast Cancer Symposium (SABCS) 2024 has been accepted for trial in progress poster
5) Prof. Biganzoli presented IMPORTANT as part of her presentation on “MDT– case of an older adult with metastatic breast cancer´´ during ESMO 2024
6) The trial clinical lead, Assoc. Prof. Antonios Valachis, attended the 1st meeting for Horizon Europe Cancer Mission ‘Diagnosis and Treatment’ cluster in Barcelona, Spain on 12 September 2024
7) The project participated at the EU Researcher’s Night event in Nicosia, Cyprus on 27 September 2024, led by Dr Vasiliki Danilatou and Assoc. Prof. Christiana Markou from Eunomia Ltd
Newsletter No5 / November 2024
1) Eight patients from four sites have completed their first 3-month follow up: Barcelona 1; Örebro 1; Helsinki 3; and Oslo 3
2) One patient from Helsinki has completed the 6-month follow up.
3) Survey investigating patterns of initial dose reduction of CDK4/6 inhibitors to older breast cancer patients has been sent to medical oncologists across the six European countries in October 2024 and will be available until November 2024.
4) The IMPORTANT study protocol has been published in Future Oncology:
“Implementing geriatric assessment for dose optimization of CDK4/6 inhibitors in older breast cancer patients”.
6) The leaflet for clinicians are ready to be circulated to all clinical sites soon.
7) IMPORTANT trial clinical lead, Assoc. Prof. Antonios Valachis, was the co-chair of the ESMO Real World Data and Digital Oncology Webinar on 23
October 2024.
Newsletter No6 / December 2024
1) 15 patients from four sites have completed their first 3-month follow up: Barcelona 5; Örebro 2; Helsinki 5; and Oslo 3
2) Three patients from Helsinki and one patient from Oslo has completed the 6-month follow up
3) IMPORTANT project was showcased at the 2024 European Cancer Summit in Brussels, Belgium on 20-21 Nov 2024. A specific section of the Summit’s display area was dedicated to EU-funded projects, aiming to provide an
overview of the landscape of EU cancer initiatives. An IMPORTANT project
slide was displayed on a screen alongside other EU cancer initiatives during the summit
Newsletter No7 / January 2025
1) 17 patients from four sites have completed their first 3-month follow up: Barcelona 5; Örebro 2; Helsinki 6; Oslo 3; and Uppsala 1
2) Three patients from Helsinki and two patients from Oslo has completed the 6-month follow up
3) HeCOG has prepared a recruitment performance report from April to December 2024. Based on 36-month inclusion period, the recruitment
progress is currently slightly below target (achieved ~25.4% of 9-month recruitment target)
4) This could be due to delays in recruitment initiation from sites in Italy and Greece. There have been regulatory and administrative delays in Greece while one site in Italy is pending CTIS approval
5) To pinpoint the difficulties in recruitment / dropouts and discuss mitigation strategies, request will be sent to clinical sites to answer dedicated questionnaire on a quarterly basis
6) Emanuela Risi (Hospital of Prato, Italy) presented IMPORTANT trial poster at the
San Antonio Breast Cancer Symposium 2024. Other IMPORTANT partners (Elena
Fountzila and Montserrat Muñoz) also attended the conference
