Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care

5168 - Anti-hormonal maintenance treatment with or without the CDK4/6 inhibitor ribociclib after 1st line chemotherapy in hormone receptor positive/HER2 negative metastatic breast cancer: a phase II trial (AMICA) GBG 98


22 Oct 2018


Poster display session: Breast cancer - early stage, locally advanced & metastatic, CNS tumours, Developmental therapeutics, Genitourinary tumours - prostate & non-prostate, Palliative care, Psycho-oncology, Public health policy, Sarcoma, Supportive care


Targeted Therapy

Tumour Site

Breast Cancer


Thomas Decker


Annals of Oncology (2018) 29 (suppl_8): viii90-viii121. 10.1093/annonc/mdy272


T. Decker1, C. Denkert2, K. Lübbe3, V. Müller4, C. Mundhenke5, J. Furlanetto6, M. Schmidt7, M. Thill8, V. Tierbach9, F. Seither10, S. Loibl6

Author affiliations

  • 1 Hämatologie, Onkologie, 88212 - Ravensburg/DE
  • 2 Institute Of Pathology, Charite Berlin Mitte, 10117 - Berlin/DE
  • 3 Onkologie, DIAKOVERE gGmbH, Hannover/DE
  • 4 Department Of Gynecology, Hamburg-Eppendorf University Medical Center, Hamburg/DE
  • 5 Klinik Für Gynäkologie Und Geburtshilfe, Universität Kiel, Kiel/DE
  • 6 Department Of Medicine And Research, German Breast Group (GBG) Forschungs GmbH, 63263 - Neu-Isenburg/DE
  • 7 ., Johannes Gutenberg-Universität Mainz, Mainz/DE
  • 8 Gynäkologie, Kliniken Markus-Krankenhaus, Agaplesion, 60431 - Frankfurt am Main/DE
  • 9 Project Management, German Breast Group (GBG) Forschungs GmbH, 63263 - Neu-Isenburg/DE
  • 10 Statistic, German Breast Group (GBG) Forschungs GmbH, 63263 - Neu-Isenburg/DE


Login to access the resources on OncologyPRO.

If you do not have an ESMO account, please create one for free.

Abstract 5168


Although longer duration of chemotherapy (CT) is associated with longer progression-free survival (PFS) and overall survival (OS) in patients with metastatic breast cancer (MBC), the duration of CT is usually dictated by toxicities and patientś and physicianś preferences, resulting in treatment durations of less than 6 months. Therefore, well tolerated maintenance treatments with the potential to prolong PFS and OS are needed.

Trial design

AMICA is a multicentre, prospectively, randomized, open-label, controlled phase II study. Patients with hormone receptor (HR)+/HER2- MBC achieving stable disease or tumor response after at least 4 cycles of first-line CT at the discretion of the investigator (e.g. taxanes, capecitabine, vinorelbine, anthracyclines) will be eligible to be randomized 2:1 to receive maintenance endocrine therapy (ET) per investigatoŕs choice either with or without the CDK4/6 inhibitor ribociclib. Patients might have received up to one prior line of ET. Maintenance ET could have already been started up to 6 weeks before randomization, but after achievement of stable disease or tumor response. Life-expectacy of > 6 months is required. In both study arms, treatment will be given until disease progression, unacceptable toxicity, or withdrawal of consent. Primary objective is to evaluate the impact of a maintenance ET after first-line CT with or without ribociclib on PFS. Secondary objectives are OS, clinical benefit rate, safety, compliance and patient reported outcomes. Biomarkers predicting response to CDK inhibition and ET in formalin-fixed paraffin-embedded metastatic tissue and blood as well as the role of mutations in ctDNA will be analysed. Overall, 150 patients will be recruited. The study is conducted in 20-30 sites in Germany. One patient has been recruited so far.

Clinical trial identification


Legal entity responsible for the study

GBG Forschungs GmbH.



Editorial Acknowledgement


C. Denkert: Personal fees: Teva, Novartis, Pfizer, Roche, Amgen, MSD Oncology; Other: Sividon Diagnostics, outside the submitted work. K. Lübbe: Consulting or advisory role: Roche and Novartis. V. Müller: Honoraria: Amgen, AstraZeneca, Daiichi Sankyo, Eisai, Pfizer, Novartis, Roche, Teva; Consolting or advisory role: Hexal, Roche, Pfizer, Amgen, Daiichi Sankyo, Nektar, EISAI; Travel accommodation: Roche, Pfizer. M. Schmidt: Honoraria: Roche, Novartis, Pfizer; Consulting or advisor role: Roche, Novartis, Pfizer; Speakers' bureau: Roche, Novartis, Pfizer; Travel accommodations: Roche, Pfizer. M. Thill: Travel reimbursement, Consulting, Honoraria: Amgen, AstraZeneca, Celgene, Eisai, Genomic Health, Lilly, Myriad, Neodynamics, Novartis, Pfizer, pfm Medical, Roche, RTI Surgical, SurgicEye, Teva; Writing assistance: Roche and Celgene; Research funding: Genomic Health. S. Loibl: Grants for Institution: AbbVie, Amgen, AstraZeneca, Celgene, Novartis, Pfizer, Roche, Teva, Vifor during the conduct of the study as well as outside the submitted work. All other authors have declared no conflicts of interest.

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings
  • Necessary cookies enable core functionality. The website cannot function properly without these cookies, and you can only disable them by changing your browser preferences.