Table 4.

Dose modification schedule and supportive care recommendations for HFSR/HFS for a phase III trial comparing capecitabine in combination with sorafenib or placebo for treatment of locally advanced or metastatic HER2-negative breast cancer (RESILIENCE)

This is intended as a brief summary of the management guidance for HFSR/HFS from the study protocol and is not the complete protocol guidance.

^aSOR/PL tablets (200 mg per tablet) administered twice per day (e.g., one tablet in morning and two tablets in evening for 600-mg dose).

^bCAP tablets administered twice per day (12 hours apart).

^cDiscontinue treatment if HFSR/HFS not resolved within 21 days.

^dReduce dose at restart after each occurrence/recurrence is resolved.

^eDose re-escalation after dose reduction for adverse events is not allowed for capecitabine but is allowed for sorafenib per protocol guidance.

Abbreviations: CAP, capecitabine; HFS, hand–foot syndrome; HFSR, hand–foot skin reaction; PL, placebo; SOR, sorafenib.