Study Protocol: Efficacy and Safety of Radioembolization (REM) as an Early Modality (EM) Therapy for Metastatic Breast Cancer (BR) to ... View Full Text


Ontology type: schema:ScholarlyArticle     


Article Info

DATE

2022-08-25

AUTHORS

Richard Wu, Keerthi Gogineni, Jane Meisel, Stephen Szabo, Meenakshi Thirunavu, Sarah Friend, Zachary Bercu, Ila Sethi, Neela Natarajan, Jeffrey Switchenko, Jason Levy, Eddie Abdalla, Laura Weakland, Kevin Kalinsky, Nima Kokabi

ABSTRACT

PurposeThe primary objective of the REMEMBR Y90 study is to evaluate the efficacy of Yttrium-90 (Y90) radioembolization in patients with breast cancer metastases to the liver as a 2nd or 3rd line treatment option with systemic therapy by assessing liver-specific and overall progression-free survival. Secondary objectives include quality of life, overall survival benefit, and toxicity in relation to patients’ tumor biology. Materials and MethodsThis trial is a multi-center, prospective, Phase 2, open-label, IRB-approved, randomized control trial in the final phases of activation. Eligible patients include those over 18 years of age with metastatic breast cancer to the liver with liver-only or liver-dominant disease, and history of tumor progression on 1–2 lines of chemotherapy. 60 patients will be randomized to radioembolization with chemotherapy versus chemotherapy alone. Permissible regimens include capecitabine, eribulin, vinorelbine, and gemcitabine within 2 weeks of enrollment for every patient. Patients receiving radioembolization will receive lobar or segmental treatment within 1–6 weeks of enrollment depending on their lesion. After final radioembolization, patients will receive clinical and imaging follow-up every 12–16 weeks for two years, including contrast-enhanced computed tomography or magnetic resonance imaging of the abdomen and whole-body positron emission tomography/computed tomography.DiscussionThis study seeks to elucidate the clinical benefit and toxicity of Y90 in patients with metastatic breast cancer to the liver who are receiving minimal chemotherapy. Given previous data, it is anticipated that the use of Y90 and chemotherapy earlier in the metastatic disease course would improve survival outcomes and reduce toxicity.Level of EvidenceLevel 1b, Randomized Controlled Trial.Trial Registration NumberNCT05315687 on clinicaltrials.gov. More... »

PAGES

1725-1734

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/s00270-022-03254-4

DOI

http://dx.doi.org/10.1007/s00270-022-03254-4

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1150500680

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/36008574


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27 schema:description PurposeThe primary objective of the REMEMBR Y90 study is to evaluate the efficacy of Yttrium-90 (Y90) radioembolization in patients with breast cancer metastases to the liver as a 2nd or 3rd line treatment option with systemic therapy by assessing liver-specific and overall progression-free survival. Secondary objectives include quality of life, overall survival benefit, and toxicity in relation to patients’ tumor biology. Materials and MethodsThis trial is a multi-center, prospective, Phase 2, open-label, IRB-approved, randomized control trial in the final phases of activation. Eligible patients include those over 18 years of age with metastatic breast cancer to the liver with liver-only or liver-dominant disease, and history of tumor progression on 1–2 lines of chemotherapy. 60 patients will be randomized to radioembolization with chemotherapy versus chemotherapy alone. Permissible regimens include capecitabine, eribulin, vinorelbine, and gemcitabine within 2 weeks of enrollment for every patient. Patients receiving radioembolization will receive lobar or segmental treatment within 1–6 weeks of enrollment depending on their lesion. After final radioembolization, patients will receive clinical and imaging follow-up every 12–16 weeks for two years, including contrast-enhanced computed tomography or magnetic resonance imaging of the abdomen and whole-body positron emission tomography/computed tomography.DiscussionThis study seeks to elucidate the clinical benefit and toxicity of Y90 in patients with metastatic breast cancer to the liver who are receiving minimal chemotherapy. Given previous data, it is anticipated that the use of Y90 and chemotherapy earlier in the metastatic disease course would improve survival outcomes and reduce toxicity.Level of EvidenceLevel 1b, Randomized Controlled Trial.Trial Registration NumberNCT05315687 on clinicaltrials.gov.
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34 DiscussionThis study
35 IRB
36 MethodsThis trial
37 Randomized Controlled Trials
38 Y90
39 Yttrium-90 Radioembolization
40 abdomen
41 activation
42 age
43 benefits
44 biology
45 breast cancer
46 breast cancer metastasis
47 cancer
48 cancer metastasis
49 capecitabine
50 chemotherapy
51 clinical benefit
52 computed tomography
53 contrast-enhanced computed tomography
54 control trial
55 course
56 data
57 disease
58 disease course
59 efficacy
60 eligible patients
61 emission tomography/
62 enrollment
63 eribulin
64 final phase
65 follow
66 gemcitabine
67 history
68 imaging
69 lesions
70 levels
71 life
72 line treatment option
73 lines
74 lines of chemotherapy
75 liver
76 liver-dominant disease
77 magnetic resonance imaging
78 materials
79 metastasis
80 metastatic breast cancer
81 minimal chemotherapy
82 modality therapy
83 objective
84 options
85 outcomes
86 overall progression-free survival
87 overall survival benefit
88 patients
89 phase
90 phase 2
91 positron emission tomography/
92 previous data
93 primary objective
94 progression
95 progression-free survival
96 quality
97 quality of life
98 radioembolization
99 regimens
100 relation
101 resonance imaging
102 safety
103 safety of radioembolization
104 secondary objective
105 study
106 survival
107 survival benefit
108 survival outcomes
109 systemic therapy
110 therapy
111 tomography
112 tomography/
113 toxicity
114 treatment
115 treatment options
116 trials
117 tumor biology
118 tumor progression
119 use
120 vinorelbine
121 weeks
122 weeks of enrollment
123 whole-body positron emission tomography/
124 years
125 years of age
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