This study is designed to evaluate the efficacy and safety of first-line treatment ribociclib in combination with aromatase inhibitor (AI) or fulvestrant OR capecitabine with bevacizumab OR paclitaxel with / without bevacizumab in patients with HR-positive, HER2-negative advanced breast cancer with visceral metastasis. Half of the patients will receive a combination of ribociclib and AI/fulvestrant while the other half will receive capecitabine + bevacizumab or paclitaxel +/- bevacizumab.
This is a prospective, randomized, open-label, two-arm, multicenter, interventional phase III trial in Germany. The study will include adult women with HR-positive, HER2-negative advanced breast cancer with visceral metastases, who received no prior therapy for advanced disease. 158 patients will be enrolled and randomized 1:1 (stratified by the presence of lung and / or liver metastases) to receive Arm A: a combination of ribociclib and AI or fulvestrant; OR Arm B: capecitabine + bevacizumab OR paclitaxel +/- bevacizumab Treatment will be continued until disease progression, intolerable toxicity or death. Progression-free survival (PFS) will be based on tumor assessments by local radiologists/investigator using RECIST v1.1 criteria. Treatment might be continued beyond RECIST-defined progressive disease (PD) in case of negligible or clinically irrelevant disease progression according to the investigator's discretion until clinically relevant disease progression or symptomatic deterioration.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
41
Combination of ribociclib and aromatase inhibitor or fulvestrant
Capecitabine with bevacizumab OR Paclitaxel with or without bevacizumab
Gemeinschaftspraxis für Hämatologie und Onkologie
Ravensburg, Baden-Wurttemberg, Germany
Uniklinik RWTH Aachen, Gynäkologie und Geburtsmedizin
Aachen, Germany
Klinikum Mittelbaden Baden-Baden Balg
Baden-Baden, Germany
Gynäkologisches Zentrum Bonn
Bonn, Germany
St.-Johannes-Hospital Gynäkologie und Geburtshilfe
Dortmund, Germany
Efficacy in terms of PFS
PFS is defined as time from randomization to progression of disease or death of any cause, whichever comes first. It will be assessed by imaging until progressive disease or start of next-line therapy.
Time frame: Up to approximately 15 months.
Overall Survival (OS)
OS is defined as time from randomization to death of any cause.
Time frame: Up to approximately 48 months.
Overall Response Rate (ORR)
ORR is defined as the proportion of patients with best overall response of complete or partial response according to RECIST 1.1.
Time frame: Up to approximately 15 months.
Clinical Benefit Rate (CBR)
CBR is defined as the proportion of patients with best overall response of complete or partial response or stable disease lasting 24 weeks or more according to RECIST 1.1.
Time frame: Up to approximately 15 months
Time To Response (TTR)
TTR is defined as time from randomization to first occurrence of any response (complete or partial) according to RECIST 1.1.
Time frame: Up to approximately 15 months.
Number of participants with Adverse Events
Type, frequency and severity (according to CTCAE v4.03) of adverse events
Time frame: Until 30 days after end of treatment, up to approximately 16 months.
Time to deterioration of ECOG performance status
Time to deterioration of ECOG performance status by at least one point from baseline.
Time frame: Until 30 days after end of treatment, up to approximately 16 months
Tolerability of treatment
By-patient listings of safety laboratory (hemoglobin, platelets, white blood cells with differentials, international normalized ratio , serum creatinine, bilirubin, Alanine-Aminotransferase (ALT) and Aspartate-Aminotransferase (AST)).
Time frame: Until 30 days after end of treatment, up to approximately 16 months.
corrected QT interval (QTc) time
By-patient listings of cardiac monitoring.
Time frame: Until 30 days after end of treatment, up to approximately 16 months.
Health-related quality of life (QoL)
Health-related QoL will be assessed with the EORTC Quality of life questionnaire (QLQ) QLQ-C30.
Time frame: Up to 36 months.
Side effects of treatment
One question on treatment burden
Time frame: Up to 36 months.
Time spent on treatment
Burden by treatment will be assessed with 4 questions on time spent on treatment
Time frame: Up to 36 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
BAG / Onkologische Gemeinschaftspraxis
Dresden, Germany
Universitätsklinikum Essen
Essen, Germany
Praxis für interdisziplinäre Onkologie & Hämatologie
Freiburg im Breisgau, Germany
Überörtliche Berufsausübungsgemeinschaft MVZ Onkologische Kooperation Harz
Goslar, Germany
Gemeinschaftspraxis für Innere Medizin, Hämatologie, Onkologie, Gastroenterologie
Halle, Germany
...and 17 more locations