Show simple item record

dc.contributor.authorCinieri, S.
dc.contributor.authorChan, Arlene
dc.contributor.authorAltundag, K.
dc.contributor.authorVandebroek, A.
dc.contributor.authorTubiana-Mathieu, N.
dc.contributor.authorBarnadas, A.
dc.contributor.authorDodyk, P.
dc.contributor.authorLazzarelli, S.
dc.contributor.authorBotha, M.
dc.contributor.authorRauch, D.
dc.contributor.authorVillanova, G.
dc.contributor.authorCoskun, U.
dc.identifier.citationCinieri, S. and Chan, A. and Altundag, K. and Vandebroek, A. and Tubiana-Mathieu, N. and Barnadas, A. and Dodyk, P. et al. 2017. Final Results of the Randomized Phase II NorCap-CA223 Trial Comparing First-Line All-Oral Versus Taxane-Based Chemotherapy for HER2-Negative Metastatic Breast Cancer. Clinical Breast Cancer. 17 (2): pp. 91-99.

© 2016 Elsevier Inc.Background: The purpose of this study was to evaluate the efficacy of 3 first-line chemotherapy combination regimens for HER2-negative metastatic breast cancer (mBC). Patients and Methods: In this open-label, 3-arm, randomized phase II trial, patients were randomized to all-oral NORCAP (vinorelbine/capecitabine), GEMPAC (gemcitabine/paclitaxel), or GEMDOC (gemcitabine/docetaxel) as first-line chemotherapy for HER2-negative mBC. Stratification factors were center, previous (neo)adjuvant anthracycline, and age. The primary end point was disease control rate (DCR; complete or partial response, or stable disease for =3 months). Results: The DCR was 73% (95% confidence interval [CI], 59-85) with NORCAP (36 of 49 patients), 78% (95% CI, 64-88) with GEMPAC (39 of 50 patients), and 80% (95% CI, 66-90) with GEMDOC (40 of 50 patients). Objective response rates were 33% (16 of 49 patients), 24% (12 of 50 patients), and 50% (25 of 50 patients), respectively; median progression-free survival was 7.6, 9.0, and 11.4 months, respectively. Median overall survival was 30 to 31 months with all regimens. The most common Grade =3 adverse event with each regimen was neutropenia (24 patients [50%], 23 patients [46%], and 43 patients [86%], respectively). The most common nonhematological Grade =3 adverse event was fatigue. Grade 2 alopecia occurred in 36 patients (72%) who received GEMPAC and 38 patients (76%) who received GEMDOC, but only 4 patients (8%) who received NORCAP. There was no evidence of a detrimental effect of NORCAP on quality of life. Conclusion: All-oral NORCAP is an active first-line chemotherapy regimen and might be offered as an alternative to first-line taxane-based therapy for HER2-negative mBC, particularly if patients wish to avoid alopecia or frequent intravenous administrations.

dc.titleFinal Results of the Randomized Phase II NorCap-CA223 Trial Comparing First-Line All-Oral Versus Taxane-Based Chemotherapy for HER2-Negative Metastatic Breast Cancer
dc.typeJournal Article
dcterms.source.titleClinical Breast Cancer
curtin.departmentCurtin Medical School
curtin.accessStatusFulltext not available

Files in this item


There are no files associated with this item.

This item appears in the following Collection(s)

Show simple item record