Abstract
BACKGROUND: Chemotherapy is commonly used in metastatic breast cancer (MBC) to prolong life and improve quality of life (QoL). The optimal dosing and sequencing beyond the second line of treatment are unknown and pose a risk of overtreatment. Continuous low oral doses of metronomic chemotherapy using capecitabine 500 mg three times daily and cyclophosphamide 50 mg once daily (MCT-CX) may be an effective and tolerable treatment option for patients with MBC. METHODS: In this open-label, single-arm single-centre phase II trial patients with MBC received MCT-CX until disease progression or unacceptable toxicity. The primary endpoint was the clinical benefit rate (CBR), defined as the proportion of participants with a best overall response of complete (CR) or partial response (PR) at any time, or stable disease (SD) for ≥24 weeks according to radiological evaluation. Toxicity was assessed according to the Common Toxicity Criteria v 4.0. QoL was assessed with the EORTC-30 questionnaire. RESULTS: In total, 40 patients were included. Most participants (72 %) presented with visceral disease and received MCT-CX beyond the second line (58 %). The CBR was 45 % (8 PR and 10 SD ≥ 24 weeks). Toxicities were low grade with hand-foot syndrome being the most common. There was no significant change in QoL over the first 24 weeks. CONCLUSION: MCT-CX is a plausible treatment option in far advanced breast cancer, with almost half of trial participants responding to treatment without QoL impairments.