A phase II study of paclitaxel plus carboplatin as first-line chemotherapy for women with metastatic breast carcinoma

Abstract Purpose Metronomic chemotherapy (MCT) is an increasingly used treatment option in hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2−) advanced/metastatic breast cancer (MBC) after failure of endocrine-based therapies. Methods VinoMetro was a multicentre, open-label, single-arm, phase II study of metronomic oral vinorelbine (VRL; 30 mg/day) as a first-line chemotherapy (CT) in patients with HR+/HER2− MBC after endocrine failure. The primary endpoint was the clinical benefit rate (CBR) at 24 weeks. Results Between January 2017 and April 2019, nine patients were enrolled. The CBR was 22.2% (90% confidence interval [CI] 4.1–55.0), p = 0.211. The median progression-free survival (PFS) was 12.0 weeks (95% CI 11.3–12.7). Grade 3–4 adverse events (AEs) occurred in 22.2% of patients. One patient died of febrile neutropenia. Conclusion VinoMetro (AGO-B-046) was closed early after nine patients and occurrence of one grade 5 toxicity in agreement with the lead institutional review board (IRB). Metronomic dosing of oral VRL in HR+/HER2− MBC as first-line CT after failure of endocrine therapies showed only limited benefit in this population. Trial registration number and date of registration ClinicalTrials.gov Identifier: NCT03007992; December 15, 2016.

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M-VAC combination in locally advanced, locally recurrent or metastatic breast carcinoma. A phase II study

Annals of Oncology ◽

10.1093/oxfordjournals.annonc.a058706 ◽

1994 ◽

Vol 5 (1) ◽

pp. 93-94 ◽

Cited By ~ 4

Author(s):

G. Bisagni ◽

G. Cocconi ◽

B. Di Blasio ◽

G. Ceci ◽

V. De Lisi ◽

...

Keyword(s):

Breast Carcinoma ◽

Phase Ii ◽

Phase Ii Study ◽

Locally Advanced ◽

Metastatic Breast ◽

Metastatic Breast Carcinoma ◽

Locally Recurrent

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Weekly paclitaxel versus weekly docetaxel in elderly and frail patients with metastatic breast carcinoma having failed previous anthracyclines: a randomised phase II study of the Belgian Society of Medical Oncology.

10.1158/0008-5472.sabcs-6115 ◽

2009 ◽

Author(s):

B Beuselinck ◽

W Wynendaele ◽

L Dirix ◽

H Wildiers ◽

R Paridaens ◽

...

Keyword(s):

Breast Carcinoma ◽

Phase Ii ◽

Medical Oncology ◽

Phase Ii Study ◽

Metastatic Breast ◽

Weekly Paclitaxel ◽

Belgian Society ◽

Metastatic Breast Carcinoma ◽

Weekly Docetaxel ◽

Frail Patients

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Vinorelbine as first-line chemotherapy for metastatic breast carcinoma.

Journal of Clinical Oncology ◽

10.1200/jco.1994.12.2.336 ◽

1994 ◽

Vol 12 (2) ◽

pp. 336-341 ◽

Cited By ~ 128

Author(s):

A Romero ◽

M G Rabinovich ◽

C T Vallejo ◽

J E Perez ◽

R Rodriguez ◽

...

Keyword(s):

Breast Cancer ◽

Metastatic Breast Cancer ◽

Breast Carcinoma ◽

Objective Response ◽

Metastatic Breast ◽

Survival Duration ◽

Severe Toxicity ◽

First Line ◽

Metastatic Breast Carcinoma ◽

Line Chemotherapy

PURPOSE A phase II trial was performed to evaluate the efficacy and toxicity of vinorelbine (VNB) as first-line chemotherapy for metastatic breast carcinoma. PATIENTS AND METHODS Between August 1991 and February 1993, 45 patients with metastatic breast cancer were entered onto the study. Therapy consisted of VNB 30 mg/m2 diluted in 500 mL of normal saline administered as a 1-hour intravenous infusion. Injections were repeated weekly until evidence of progressive disease (PD) or severe toxicity developed. RESULTS One patient was considered not assessable for response. An objective response (OR) was observed in 18 of 44 patients (41%; 95% confidence interval, 26% to 56%). Three patients (7%) had a complete response (CR) and 15 (34%) had a partial response (PR). The median time to treatment failure for the entire group was 6 months (range, 1 to 15), and the median duration of response was 9 months (range, 1 to 15). The median survival duration has not been reached yet. There were no treatment-related deaths. The dose-limiting toxicity was myelosuppression. Leukopenia occurred in 35 patients (78%) and was grade 3 or 4 in 16 (36%). Phlebitis was observed in 19 of 29 patients (66%) who did not have central implantable venous systems. Fifteen patients (33%) developed peripheral neurotoxicity. Myalgia occurred in 20 patients (44%). CONCLUSION VNB is an active drug against metastatic breast cancer with moderate toxicity, which justifies further evaluation in association with other agents.

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