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.
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
AMICA, GBG 97.
Legal entity responsible for the study
GBG Forschungs GmbH.
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.