Randomized Phase II Trial of Capecitabine and Lapatinib with or without IMC-A12 (Cituxumumab) in Patients with HER2-Positive Advanced Breast Cancer Previously Treated with Trastuzumab and Chemotherapy: NCCTG N0733 (Alliance).

Szczegóły
Abstrakt

Tytuł:: Randomized Phase II Trial of Capecitabine and Lapatinib with or without IMC-A12 (Cituxumumab) in Patients with HER2-Positive Advanced Breast Cancer Previously Treated with Trastuzumab and Chemotherapy: NCCTG N0733 (Alliance).
Autorzy:: Haddad TC; Mayo Clinic, 200 1st Street SW, Rochester, MN, 55905, USA. .
He J; Alliance Statistics and Data Management Center, Mayo Clinic, Rochester, MN, USA.
O'Sullivan CC; Mayo Clinic, 200 1st Street SW, Rochester, MN, 55905, USA.
Chen B; Mayo Clinic, 200 1st Street SW, Rochester, MN, 55905, USA.
Northfelt D; Mayo Clinic, Scottsdale, AZ, USA.
Dueck AC; Mayo Clinic, Scottsdale, AZ, USA.
Ballman KV; Weill Cornell Medical College, New York, NY, USA.
Tenner KS; Mayo Clinic, 200 1st Street SW, Rochester, MN, 55905, USA.
Linden H; Seattle Cancer Care Alliance, Seattle, WA, USA.
Sparano JA; Montefiore Medical Center, Bronx, NY, USA.
Hopkins JO; Southeast Clinical Oncology Research (SCOR) Consortium, Winston-Salem, NC, USA.
De Silva C; Kaiser Permanente-Rock Creek, Lafayette, CO, USA.
Perez EA; Mayo Clinic, Jacksonville, FL, USA.
Haluska P; Mayo Clinic, 200 1st Street SW, Rochester, MN, 55905, USA.
Goetz MP; Mayo Clinic, 200 1st Street SW, Rochester, MN, 55905, USA.
Źródło:: Breast cancer research and treatment [Breast Cancer Res Treat] 2021 Jul; Vol. 188 (2), pp. 477-487. Date of Electronic Publication: 2021 Apr 14.
Typ publikacji:: Clinical Trial, Phase II; Journal Article; Randomized Controlled Trial
Język:: English
Imprint Name(s):: Publication: Dordrecht : Kluwer Academic
Original Publication: The Hague ; Boston : M. Nijhoff, c1981-
MeSH Terms:: Breast Neoplasms*/drug therapy
Quality of Life*
Antibodies, Monoclonal, Humanized ; Antineoplastic Combined Chemotherapy Protocols/adverse effects ; Capecitabine/therapeutic use ; Disease-Free Survival ; Female ; Humans ; Lapatinib/therapeutic use ; Quinazolines/adverse effects ; Receptor, ErbB-2/genetics ; Trastuzumab/therapeutic use
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Grant Information:: U10 CA180868 United States CA NCI NIH HHS; U10CA180820 Foundation for the National Institutes of Health; UG1 CA189859 United States CA NCI NIH HHS; U10 CA180821 United States CA NCI NIH HHS; UG1 CA232760 United States CA NCI NIH HHS; P30 CA015083 United States CA NCI NIH HHS; U10 CA180882 United States CA NCI NIH HHS; U10CA180882 Foundation for the National Institutes of Health; U10 CA180888 United States CA NCI NIH HHS; U10CA180888 Foundation for the National Institutes of Health; UG1CA189859 Foundation for the National Institutes of Health; UG1CA232760 Foundation for the National Institutes of Health; R01 CA214893 United States CA NCI NIH HHS; UG1 CA189821 United States CA NCI NIH HHS; U10CA180868 Foundation for the National Institutes of Health; UG1CA189821 Foundation for the National Institutes of Health; U10 CA180820 United States CA NCI NIH HHS; U10CA180821 Foundation for the National Institutes of Health
Contributed Indexing:: Keywords: HER2-positive; Insulin-like growth factor receptor; Metastatic breast cancer; Trastuzumab-resistance
Molecular Sequence:: ClinicalTrials.gov NCT00684983
Substance Nomenclature:: 0 (Antibodies, Monoclonal, Humanized)
0 (Quinazolines)
0VUA21238F (Lapatinib)
2285XW22DR (cixutumumab)
6804DJ8Z9U (Capecitabine)
EC 2.7.10.1 (Receptor, ErbB-2)
P188ANX8CK (Trastuzumab)
Entry Date(s):: Date Created: 20210414 Date Completed: 20210708 Latest Revision: 20230131
Update Code:: 20240104
PubMed Central ID:: PMC8262517
DOI:: 10.1007/s10549-021-06221-8
PMID:: 33852121
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Purpose: To compare efficacy and safety of capecitabine and lapatinib with or without IMC-A12 (cituxumumab) in patients with HER2-positive metastatic breast cancer (MBC) previously treated with trastuzumab.
Patients and Methods: Following an initial safety run-in cohort, patients were randomized 1:2 to Arm A (capecitabine and lapatinib) or to Arm B (capecitabine, lapatinib, and cituxumumab). Given the frequency of non-hematologic grade ≥ 3 adverse events in those receiving the three-drug combination in the safety cohort, lapatinib and capecitabine doses were reduced in Arm B only. The primary objective was to determine if the addition of cituxumumab to capecitabine and lapatinib improved progression-free survival (PFS) compared with capecitabine and lapatinib. Secondary objectives included a comparison between arms of other clinical endpoints, safety, change in overall quality of life (QOL) and self-assessed fatigue, rash, diarrhea, and hand-foot syndrome.
Results: From July 2008 to March 2012, 68 patients (out of 142 planned) were enrolled and 63 were evaluable, including 8 for the safety run-in and 55 for the randomized cohort. Study enrollment was stopped early due to slow accrual. The addition of cituxumumab to capecitabine and lapatinib did not improve PFS (HR 0.93, 95% CI: 0.52-1.64). Furthermore, no difference in objective response rate or overall survival (OS) was observed. No difference between arms was observed in grade ≥ 3 adverse events, overall QOL change from baseline after 4 cycles of treatment.
Conclusion: The addition of cituxumumab to lapatinib and capecitabine did not improve PFS or OS compared with lapatinib and capecitabine in patients with HER2-positive MBC.
Clinical Trial Registry: ClinicalTrials.gov Identifier: NCT00684983.

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