PMID- 37690320
OWN - NLM
STAT- MEDLINE
DCOM- 20231206
LR  - 20231206
IS  - 1532-3080 (Electronic)
IS  - 0960-9776 (Print)
IS  - 0960-9776 (Linking)
VI  - 72
DP  - 2023 Dec
TI  - Anti-hormonal maintenance treatment with the CDK4/6 inhibitor ribociclib after 
      1st line chemotherapy in hormone receptor positive / HER2 negative metastatic 
      breast cancer: A phase II trial (AMICA).
PG  - 103575
LID - S0960-9776(23)00542-8 [pii]
LID - 10.1016/j.breast.2023.08.007 [doi]
LID - 103575
AB  - PURPOSE: This phase II study evaluated the impact of adding ribociclib to 
      maintenance endocrine therapy (ET) treatment of physicians' choice following the 
      first palliative chemotherapy in pre- and post-menopausal women with hormone 
      receptor positive (HR+)/human epidermal growth factor 2 negative (HER2-) 
      metastatic breast cancer (mBC). PATIENTS AND METHODS: The initial randomized 
      study design was later amended into a single-arm study, and all subsequent 
      patients received ribociclib and ET. The primary end point was locally assessed 
      progression-free survival (PFS). Secondary end points included overall survival 
      (OS), clinical benefit rate (CBR), safety, compliance, and quality of life (QoL). 
      RESULTS: A total of 43 patients received ribociclib + ET and 10 patients received 
      ET only. Median PFS was 12.4 months [95% CI 8.7-24.4] for patients who received 
      ribociclib + ET and 4.75 months [95% CI 1.0-10.3] for those who received ET only. 
      Median OS was not reached for patients who received ribociclib + ET, and 28 
      (65.1%) patients experienced clinical benefit [95% CI 49.1-79.0]. For patients 
      who received ribociclib + ET, grade 3-4 hematological adverse events (AEs) 
      occurred in 25 (58.1%) patients, and grade 3-4 non-hematological AEs occurred in 
      17 (39.5%) patients. During the study, 15 patients died - 14 of whom due to 
      tumor-related reasons, and one patient due to pneumonia, which was not 
      treatment-related. CONCLUSION: The results of the AMICA study show a promising 
      efficacy and safety of maintenance treatment with ribociclib added to ET after at 
      least stable disease following the first metastatic chemotherapy in patients with 
      HR+/HER2-mBC. TRIAL REGISTRATION: Anti-hormonal Therapy With Ribociclib in 
      HR-positive/HER2- Negative Metastatic Breast Cancer (AMICA), NCT03555877, 
      https://clinicaltrials.gov/ct2/show/NCT03555877.
CI  - Copyright (c) 2023. Published by Elsevier Ltd.
FAU - Decker, Thomas
AU  - Decker T
AD  - Studienzentrum Onkologie, Ravensburg, Germany.
FAU - Ludtke-Heckenkamp, Kerstin
AU  - Ludtke-Heckenkamp K
AD  - Franziskus-Hospital Harderberg Georgsmarienhutte, Germany.
FAU - Melnichuk, Luidmila
AU  - Melnichuk L
AD  - Asklepios Paulinen Klinik Wiesbaden, Germany.
FAU - Hirmas, Nader
AU  - Hirmas N
AD  - German Breast Group (GBG) Forschungs GmbH, Neu-Isenburg, Germany.
FAU - Lubbe, Kristina
AU  - Lubbe K
AD  - Diakovere Henriettenstift, Breast Center, Hannover, Germany.
FAU - Zahn, Mark-Oliver
AU  - Zahn MO
AD  - MVZ Onkologische Kooperation Harz, Goslar, Germany.
FAU - Schmidt, Marcus
AU  - Schmidt M
AD  - Universitatsmedizin Mainz, Germany.
FAU - Denkert, Carsten
AU  - Denkert C
AD  - Institut fur Pathologie, Philipps Universitat Marburg und Universitatsklinikum 
      Marburg (UKGM), Germany.
FAU - Lorenz, Ralf
AU  - Lorenz R
AD  - Frauenarztliche Gemeinschaftspraxis Braunschweig, Germany.
FAU - Muller, Volkmar
AU  - Muller V
AD  - Universitatsklinikum Hamburg-Eppendorf, Hamburg, Germany.
FAU - Zahm, Dirk-Michael
AU  - Zahm DM
AD  - SH Wald-Klinikum Gera, Germany.
FAU - Mundhenke, Christoph
AU  - Mundhenke C
AD  - Gynakologisches Krebszentrum, Klinikum Bayreuth, Germany.
FAU - Bauer, Stefan
AU  - Bauer S
AD  - Gemeinschaftspraxis fur Hamatologie und Onkologie, Lebach, Germany.
FAU - Thill, Marc
AU  - Thill M
AD  - Department of Gynecology and Gynecological Oncology, Agaplesion Markus 
      Krankenhaus Frankfurt, Germany.
FAU - Seropian, Peter
AU  - Seropian P
AD  - Krankenhauser Landkreis Freudenstadt gGmbH, Germany.
FAU - Filmann, Natalie
AU  - Filmann N
AD  - German Breast Group (GBG) Forschungs GmbH, Neu-Isenburg, Germany.
FAU - Loibl, Sibylle
AU  - Loibl S
AD  - German Breast Group (GBG) Forschungs GmbH, Neu-Isenburg, Germany; Centre for 
      Haematology and Oncology/Bethanien Frankfurt/M Freudenstadt, Germany. Electronic 
      address: sibylle.loibl@gbg.de.
LA  - eng
SI  - ClinicalTrials.gov/NCT03555877
PT  - Clinical Trial, Phase II
PT  - Journal Article
DEP - 20230901
PL  - Netherlands
TA  - Breast
JT  - Breast (Edinburgh, Scotland)
JID - 9213011
RN  - 0 (Aminopyridines)
RN  - EC 2.7.11.22 (CDK4 protein, human)
RN  - EC 2.7.11.22 (Cyclin-Dependent Kinase 4)
RN  - EC 2.7.10.1 (Receptor, ErbB-2)
RN  - TK8ERE8P56 (ribociclib)
RN  - EC 2.7.11.22 (Cyclin-Dependent Kinase 6)
SB  - IM
MH  - Female
MH  - Humans
MH  - Aminopyridines
MH  - Antineoplastic Combined Chemotherapy Protocols/therapeutic use
MH  - *Breast Neoplasms/drug therapy/pathology
MH  - Cyclin-Dependent Kinase 4/antagonists & inhibitors
MH  - Quality of Life
MH  - Receptor, ErbB-2/metabolism
MH  - Cyclin-Dependent Kinase 6/antagonists & inhibitors
PMC - PMC10507224
OTO - NOTNLM
OT  - AMICA
OT  - Advanced breast cancer
OT  - Clinical response
OT  - Efficacy
OT  - HER2 negative
OT  - Hormone receptor positive
OT  - Metastatic breast cancer
OT  - Quality of life
OT  - Ribociclib
OT  - Safety
COIS- Declaration of competing interest The authors declare that they have no known 
      competing financial interests or personal relationships that could have appeared 
      to influence the work reported in this paper. T. Decker reports ad boards from 
      Lilly, Novartis, and IOMEDICO. K. Luedtke-Heckenkamp reports personal fees from 
      AstraZeneca, Gilead, Novartis, and Pfizer. She is on the advisory board of 
      Daiichi Sankyo, Lilly, and Roche. K. Lubbe is on the advisory board of Genomic 
      Health, Roche, Daiichy Sankyo, Lilly, MSD, EISAI, Seagen, and Novartis, and has 
      received lecture fees from Novartis, AstraZeneca, Genomic Health, Roche, and 
      Lilly. M. Schmidt reports personal fees from AstraZeneca, personal fees from 
      BioNTech, personal fees from Daiichi Sankyo, personal fees from Eisai, personal 
      fees from Lilly, personal fees from MSD, personal fees from Novartis, personal 
      fees from Pfizer, personal fees from Pierre-Fabre, personal fees from Roche, and 
      personal fees from SeaGen outside the submitted work; in addition, M. Schmidt has 
      a patent for EP 2390370 B1: A method for predicting the response of a tumor in a 
      patient suffering from or at risk of developing recurrent gynecologic cancer 
      towards a chemotherapeutic agent issued and a patent for EP 2951317 B1: A method 
      for predicting the benefit from inclusion of a taxane in a chemotherapy regimen 
      in patients with breast cancer issued. C. Denkert reports grants from European 
      Commission H2020, grants from German Cancer Aid Translational Oncology, grants 
      from German Breast Group; personal fees from Novartis, Roche, MSD Oncology, 
      Daiichi Sankyo, AstraZeneca, Lilly, Molecular Health, Merck, grants from Myriad 
      to his institution, other from Sividon diagnostics (cofounder and former 
      shareholder until 2016); In addition, C. Denkert has a patent VMScope digital 
      pathology software with royalties paid, a patent WO2020109570A1 - cancer 
      immunotherapy pending, and a patent WO2015114146A1 and WO2010076322A1- therapy 
      response issued. V. Muller received speaker honoraria from Amgen, Astra Zeneca, 
      Daiichi-Sankyo, Eisai, GSK, Pfizer, MSD, Medac, Novartis, Roche, Teva, Seagen, 
      Onkowissen, high5 Oncology, Medscape, Gilead, and Pierre Fabre; consultancy 
      honoraria from Hexal, Roche, Pierre Fabre, Amgen, ClinSol, Novartis, MSD, 
      Daiichi-Sankyo, Eisai, Lilly, Sanofi, Seagen, and Gilead; institutional research 
      support from Novartis, Roche, Seagen, and Genentech; and travel grants from 
      Roche, Pfizer, Daiichi Sankyo, and Gilead. M. Thill is on the advisory boards of 
      Agendia, Amgen, AstraZeneca, Aurikamed, Becton/Dickinson, Biom'Up, ClearCut, 
      Clovis, Daiichi Sankyo, Eisai, Exact Sciences, Gilead Science, Grunenthal, GSK, 
      Lilly, MSD, Norgine, Neodynamics, Novartis, Onkowissen, Organon, Pfizer, pfm 
      Medical, Pierre-Fabre, Roche, RTI Surgical, Seagen, Sirius Pintuition, and 
      Sysmex. He has received support from Amgen, AstraZeneca, Celgene, ClearCut, 
      Clovis, Daiichi Sanyko, Hexal, Neodynamics, Novartis, Pfizer, pfm medical, Roche, 
      Servier, and Sirius Medical. He reports travels expenses from Amgen, Art Tempi, 
      AstraZeneca, Clearcut, Clovis, Connect Medica, Daiichi Sankyo, Eisai, Exact 
      Sciences, Hexal, I-Med-Institute, Lilly, MCI, Medtronic, MSD, Neodynamics, 
      Norgine, Novartis, Pfizer, pfm Medical, Roche, RTI Surgical, and Seagen. He has 
      received honoraria and funding from Amgen, Art Tempi, AstraZeneca, Biom'Up, 
      Celgene, Clearcut, Clovis, Connect Medica, Eisai, Endomag, Exact Sciences, Gedeon 
      Richter, Gilead Science, GSK, Hexal, I-Med-Institute, Jorg Eickeler, 
      Laborarztpraxis Walther et al., Lilly, MCI, Medscape, MSD, Medtronic, 
      Neodynamics, Novartis, Onkowissen, Pfizer, pfm medical, Roche, RTI Surgical, 
      Seagen, StreamedUp, Sysmex, Vifor, and Viatris. N. Hirmas and N. Filmann declare 
      to be GBG Forschungs GmbH employees. GBG Forschungs GmbH received funding for 
      research grants from Abbvie, AstraZeneca, BMS, Daiichi-Sankyo, Gilead, Novartis, 
      Pfizer, and Roche (paid to the institution); other (non-financial/medical 
      writing) from Daiichi-Sankyo, Gilead, Novartis, Pfizer, Roche and Seagen (paid to 
      the institution). GBG Forschungs GmbH has following royalties/patents: 
      EP14153692.0, EP21152186.9, EP15702464.7, EP19808852.8 and VM Scope GmbH. S. 
      Loibl reports grants or contracts paid to institute from Abbvie, AstraZeneca, 
      DSI, Celgene, Gilead, Novartis, Pfizer, Roche, Molecular H; in addition, S. Loibl 
      has royalties or licenses for Digital Ki67 Evaluator from VM Scope GmbH that were 
      paid to institute; in addition, S. Loibl receives honorary for lectures paid to 
      the institute from AstraZeneca, DSI, Gilead, Novartis, Pfizer, and Roche; 
      non-financial for Medical Writing from DSI, Gilead, Novartis, Pfizer, Roche, and 
      Seagen; in addition, S. Loibl has patent for EP14153692.0, EP21152186.9, 
      EP15702464.7 and EP19808852.8, all patents via institute; in addition, S. Loibl 
      declares participation on a Data Safety Monitoring Board or Advisory Board from 
      Abbvie, Amgen, AstraZeneca, BMS, Celgene, DSI, Eirgenix, Eisai Europe, GSK, 
      Gilead, Lilly, Merck, Novartis, Pfizer, Pierre Fabre, Relay Therapeutics, Roche, 
      Sanofi, and Seagen, all paid to institute.
EDAT- 2023/09/11 00:42
MHDA- 2023/12/05 12:42
PMCR- 2023/09/01
CRDT- 2023/09/10 18:07
PHST- 2023/07/05 00:00 [received]
PHST- 2023/08/30 00:00 [revised]
PHST- 2023/08/31 00:00 [accepted]
PHST- 2023/12/05 12:42 [medline]
PHST- 2023/09/11 00:42 [pubmed]
PHST- 2023/09/10 18:07 [entrez]
PHST- 2023/09/01 00:00 [pmc-release]
AID - S0960-9776(23)00542-8 [pii]
AID - 103575 [pii]
AID - 10.1016/j.breast.2023.08.007 [doi]
PST - ppublish
SO  - Breast. 2023 Dec;72:103575. doi: 10.1016/j.breast.2023.08.007. Epub 2023 Sep 1.