@article{3078780, title = "Phase 2 study of cabazitaxel as second-line treatment in patients with HER2-negative metastatic breast cancer previously treated with taxanes—a Hellenic Cooperative Oncology Group (HeCOG) Trial", author = "Koutras, A. and Zagouri, F. and Koliou, G.-A. and Psoma, E. and Chryssogonidis, I. and Lazaridis, G. and Tryfonopoulos, D. and Kotsakis, A. and Res, E. and Kentepozidis, N.K. and Razis, E. and Psyrri, A. and Koumakis, G. and Kalofonos, H.P. and Dimopoulos, M.A. and Fountzilas, G.", journal = "British Journal of Cancer", year = "2020", volume = "123", number = "3", pages = "355-361", publisher = "Springer Nature BV", issn = "0007-0920, 1532-1827", doi = "10.1038/s41416-020-0909-4", keywords = "alkaline phosphatase; cabazitaxel; gamma glutamyltransferase; granulocyte colony stimulating factor; lactate dehydrogenase; cabazitaxel; epidermal growth factor receptor 2; ERBB2 protein, human; taxoid, acute kidney failure; adult; aged; anemia; Article; bone pain; cancer chemotherapy; cancer survival; diarrhea; drug activity; drug dose reduction; drug efficacy; drug safety; drug withdrawal; dyspnea; estrogen receptor negative breast cancer; estrogen receptor positive breast cancer; fatigue; febrile neutropenia; female; follow up; headache; human; human epidermal growth factor receptor 2 negative breast cancer; hypermagnesemia; hypertension; hypokalemia; intention to treat analysis; leukopenia; lymphocytopenia; major clinical study; metastatic breast cancer; multicenter study; multiple cycle treatment; nausea; necrotizing enterocolitis; neutropenia; neutropenic enterocolitis; overall survival; pain; patient compliance; peripheral neuropathy; phase 2 clinical trial; priority journal; progesterone receptor positive breast cancer; progression free survival; sensory neuropathy; sepsis; side effect; skin infection; thrombocytopenia; treatment response; breast tumor; clinical trial; drug effect; drug resistance; genetics; metastasis; middle aged; survival analysis; treatment outcome, Adult; Aged; Breast Neoplasms; Drug Resistance, Neoplasm; Female; Humans; Middle Aged; Neoplasm Metastasis; Receptor, ErbB-2; Survival Analysis; Taxoids; Treatment Outcome", abstract = "Background: Cabazitaxel is a novel taxane that might be active in breast cancer resistant to first-generation taxanes. Methods: The purpose of the current multicentre phase II trial was to evaluate the activity and safety of cabazitaxel, as second-line treatment, in patients with human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer (MBC) previously treated with taxanes. The primary endpoint was objective response rate (ORR). Results: Eighty-four patients were enrolled between October 2012 and November 2016. Taxane resistance to previous treatment was detected in 43 cases. The ORR was 22.6% in the intent-to-treat population, 23.3% in taxane-resistant and 20.5% in taxane-non-resistant cases. At a median follow-up of 39.6 months, the median progression-free survival and overall survival were 3.7 months (95% CI 2.2–4.4) and 15.2 months (95% CI 11.3–19.4), respectively. Regarding toxicity, grade 3–4 neutropenia was reported in 22.6% and febrile neutropenia in 6% of the patients, respectively. Two fatal events (one febrile neutropenia and one sepsis) were reported as being related to study treatment. Conclusions: This phase II trial suggests that cabazitaxel is active as second-line treatment in taxane-pretreated patients with HER2-negative MBC, with manageable toxicity. © 2020, The Author(s), under exclusive licence to Cancer Research UK." }