Clinical Observation Of External Compound Chinese Herbal Extract Lc09 With Capecitabine Maintenance Therapy After Response To Capecitabine-Based Combination Chemotherapy In Patients With Metastatic Breast Cancer.

e12006 Background: Capecitabine(Cape) maintenance therapy after response to Cape-based combination chemotherapy(chemo) is one of the standard regimens recommended by NCCN for metastatic breast cancer(MBC) treatment. Hand-foot syndrome (HFS) induced by Cape may lead to dose modification or treatment interruption, even when the therapy may prove beneficial. The earlier-phase data of external compound Chinese herbal extract LC09 (Herba Geranii, etc.) has shown significant effective on treating HFS. This study aimed to evaluate the efficacy of LC09 with Cape maintenance therapy in MBC. Methods: MBC patients (pts) who responded to the first-line Cape-based combination chemo (docetaxel/navelbine/gemcitabine and cape, 6 cycles) were assigned to Cape maintenance therapy until disease progression or intolerable toxicity. Pts were randomly to receive LC09 and Cape (LC09 Group) versus single Cape (Control Group). Cape 1,000 mg/m2, PO, twice daily, d1-14, every 21 days. LC09 granules 10g was dissolved in 1,000ml of w...